| 1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 70(1):7-30, 2020 01. |
Review/Other-Dx |
N/A |
Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data. |
Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data on population-based cancer occurrence. Incidence data (through 2016) were collected by the Surveillance, Epidemiology, and End Results Program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data (through 2017) were collected by the National Center for Health Statistics. In 2020, 1,806,590 new cancer cases and 606,520 cancer deaths are projected to occur in the United States. The cancer death rate rose until 1991, then fell continuously through 2017, resulting in an overall decline of 29% that translates into an estimated 2.9 million fewer cancer deaths than would have occurred if peak rates had persisted. This progress is driven by long-term declines in death rates for the 4 leading cancers (lung, colorectal, breast, prostate); however, over the past decade (2008-2017), reductions slowed for female breast and colorectal cancers, and halted for prostate cancer. In contrast, declines accelerated for lung cancer, from 3% annually during 2008 through 2013 to 5% during 2013 through 2017 in men and from 2% to almost 4% in women, spurring the largest ever single-year drop in overall cancer mortality of 2.2% from 2016 to 2017. Yet lung cancer still caused more deaths in 2017 than breast, prostate, colorectal, and brain cancers combined. Recent mortality declines were also dramatic for melanoma of the skin in the wake of US Food and Drug Administration approval of new therapies for metastatic disease, escalating to 7% annually during 2013 through 2017 from 1% during 2006 through 2010 in men and women aged 50 to 64 years and from 2% to 3% in those aged 20 to 49 years; annual declines of 5% to 6% in individuals aged 65 years and older are particularly striking because rates in this age group were increasing prior to 2013. It is also notable that long-term rapid increases in liver cancer mortality have attenuated in women and stabilized in men. In summary, slowing momentum for some cancers amenable to early detection is juxtaposed with notable gains for other common cancers. |
4 |
| 2. Roehrborn CG, Black LK. The economic burden of prostate cancer. BJU Int. 2011;108(6):806-813. |
Review/Other-Dx |
N/A |
To discuss expenditure on prostate cancer diagnosis, treatment and follow-up and evaluate the cost of prostate cancer and its management in different countries. |
A high proportion of the costs are incurred in the first year after diagnosis; in 2006, this amounted to 106.7-179.0 million euros (euro) in the European countries where these data were available (UK, Germany, France, Italy, Spain and the Netherlands). In the USA, the total estimated expenditure on prostate cancer was 9.862 billion US dollars ($) in 2006. The mean annual costs per patient in the USA were $10,612 in the initial phase after diagnosis, $2134 for continuing care and $33,691 in the last year of life. In Canada, hospital and drug expenditure on prostate cancer totalled C$103.1 million in 1998. In Australia, annual costs for prostate cancer care in 1993-1994 were 101.1 million Australian dollars. Variations in costs between countries were attributed to differences in incidence and management practices. Per patient costs depend on cancer stage at diagnosis, survival and choice of treatment. Despite declining mortality rates, costs are expected to rise owing to increased diagnosis, diagnosis at an earlier stage and increased survival. |
4 |
| 3. Evans AJ, Henry PC, Van der Kwast TH, et al. Interobserver variability between expert urologic pathologists for extraprostatic extension and surgical margin status in radical prostatectomy specimens. Am J Surg Pathol 2008;32:1503-12. |
Observational-Dx |
200 original hematoxylin and eosin slides. |
To report interobserver variability in a group of expert pathologists concerning extraprostatic soft tissue (EPE) and SM interpretation for radical prostatectomy specimens. |
On the basis of panel diagnoses, as the gold standard, specificity, sensitivity, and accuracy values were high for both EPE (87.5%, 95.0%, and 91.2%) and SM (97.5%, 83.3%, and 90.4%). Overall kappa values for all 60 slides were 0.74 for SM and 0.63 for EPE. The kappa values were higher for slides with definitive gold standard EPE (kappa=0.81) and SM (kappa=0.73) diagnoses when compared with the EPE (kappa=0.29) and SM (kappa=0.62) equivocal slides. |
3 |
| 4. van der Kwast TH, Collette L, Van Poppel H, et al. Impact of pathology review of stage and margin status of radical prostatectomy specimens (EORTC trial 22911). Virchows Arch. 2006;449(4):428-434. |
Experimental-Dx |
552 patients |
To report on the degree of interobserver variation between local pathologists and review pathology (by a single pathologist) for pathological stage, including seminal vesicle invasion and extraprostatic extension, and for surgical margin status. In addition, the prognostic impact of these parameters was analyzed using biochemical recurrence-free survival (PSA failure after prostatectomy) as outcome parameter. |
Although a high concordance between review pathology and local pathologists existed for seminal vesicle invasion (94%, kappa=0.83), agreement was much less for extraprostatic extension (57.5%, kappa=0.33) and for surgical margin status (69.4%, kappa=0.45). Review pathology of surgical margin status was a stronger predictor of biochemical progression-free survival in univariate analysis [hazard ratio (HR)=2.16 and p=0.0002] than local pathology (HR=1.08 and p>0.1). The review pathology demonstrated a significant difference between those with and without extraprostatic extension (HR=1.83 and p=0.0017), while local pathology failed to do so (HR=1.05 and p>0.8). |
2 |
| 5. localization Graser A, Heuck A, Sommer B, et al. Per-sextant localization and staging of prostate cancer: correlation of imaging findings with whole-mount step section histopathology. AJR Am J Roentgenol 2007;188:84-90. |
Observational-Dx |
106 patients |
To determine the diagnostic accuracy and interobserver agreement of 1.5-T prostatic MRI for per-sextant tumor localization and staging of prostate cancer as compared with whole-mount step section histopathology. |
Forty-one patients had ECE (tumor stage T3), and 65 patients had organ-confined disease (stage T2). Of 636 prostatic sextants, 417 were positive for prostate cancer and 135 were positive for ECE at histopathology. For prostate cancer localization, ROC analysis yielded area under the ROC curve (AUC) values ranging from 0.776 +/- 0.023 (SD) to 0.832 +/- 0.027. For the detection of ECE, the AUC values ranged from 0.740 +/- 0.054 to 0.812 +/- 0.045. Interobserver agreement (kappa) ranged from 0.49 to 0.60 for prostate cancer localization and from 0.59 to 0.67 for the detection of ECE. |
3 |
| 6. D'Amico AV, Whittington R, Malkowicz SB, et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. Jama. 1998;280(11):969-974. |
Observational-Tx |
1,872 patients; 888 treated with RP; 218 treated with implant with or without neoadjuvant ADT; 766 treated with RT |
To estimate control of PSA after RP, EBRT, or implant with or without neoadjuvant ADT in patients with clinically localized prostate cancer. |
The relative risk of PSA failure in low-risk patients (stage T1c, T2a and PSA level =10 ng/mL and GS =6) treated using RT, implant plus ADT, or implant therapy was 1.1 compared with those patients treated with RP. The addition of ADT to implant therapy did not improve PSA outcome in high-risk patients but resulted in a PSA outcome that was not statistically different compared with the results obtained using RP or RT in intermediate-risk patients. Intermediate- and high-risk patients treated with EBRT or RP fared better than brachytherapy. |
2 |
| 7. Eifler JB, Feng Z, Lin BM, et al. An updated prostate cancer staging nomogram (Partin tables) based on cases from 2006 to 2011. BJU Int. 2013;111(1):22-29. |
Review/Other-Dx |
5,629 consecutive men |
To update the 2007 Partin tables in a contemporary patient population. |
The median PSA was 4.9 ng/mL, 63% had Gleason 6 disease, and 78% of men had T1c disease. 73% of patients had organ-confined disease, 23% had EPE, 3% had SV+ but not LN+, and 1% had LN+ disease. Compared to the previous Partin nomogram, there was no change in the distribution of pathologic state. The risk of LN+ disease was significantly higher for tumors with biopsy Gleason 9–10 than Gleason 8 (organ-confined disease 3.2, 95% CI 1.3–7.6). The c-indexes for EPE vs organ-confined disease, SV+ vs organ-confined disease, and LN+ vs organ-confined disease were 0.702, 0.853, and 0.917, respectively. Men with biopsy Gleason 4+3 and Gleason 8 had similar predicted probabilities for all pathologic stages. Most men presenting with Gleason 6 disease or Gleason 3+4 disease have <2% risk of harboring LN+ disease and may have lymphadenectomy omitted at RP. |
4 |
| 8. Karakiewicz PI, Bhojani N, Capitanio U, et al. External validation of the updated Partin tables in a cohort of North American men. J Urol. 2008; 180(3):898-902; discussion 902-893. |
Observational-Dx |
1,838 patients |
To confirm the accuracy and performance characteristics of Partin tables in an external validation cohort. Three metrics - overall accuracy (AUC), Brier score and calibration plots – were assessed in a large cohort of men. |
The rates of extraprostatic extension, SVI and lymph node invasion were 26.9%, 5.5% and 1.8%. The accuracy of extraprostatic extension, SVI and lymph node invasion prediction was 71%, 80% and 75% according to the AUC method, and 0.176, 0.051 and 0.037 according to the Brier score, respectively. Extraprostatic extension predictions between 0% and 25%, and lymph node invasion predictions between 0% and 5% correlated well with observed extraprostatic extension and lymph node invasion rates, respectively. Conversely a suboptimal correlation was recorded between predicted and observed SVI rates as well as between predicted and observed rates of extraprostatic extension and lymph node invasion for predicted extraprostatic extension and lymph node invasion values above 25% and 5%, respectively. In this examined validation cohort the overall accuracy of the Partin tables was comparable to results reported in the original 2007 development cohort. However, performance characteristics indicate that predictions within specific probability ranges should be interpreted with caution. |
3 |
| 9. Yu JB, Makarov DV, Sharma R, Peschel RE, Partin AW, Gross CP. Validation of the partin nomogram for prostate cancer in a national sample. J Urol. 2010; 183(1):105-111. |
Observational-Dx |
11,185 patients |
To validate the Partin nomogram for prostate cancer in a large, population based sample. |
The Partin tables discriminated well between patient groups at risk for positive lymph nodes and SVI (AUC 0.77 and 0.74, respectively). The discrimination of extraprostatic extension and organ confined disease was more limited (AUC 0.62 and 0.68, respectively). The AUC for positive lymph nodes was 0.78 in white men, 0.73 in black men and 0.83 in Asian/Pacific Islander men (P=0.17). The AUC for positive lymph nodes in men 61 years old or younger was 0.80 vs 0.74 in men older than 61 years (P=0.03). The Partin tables showed excellent discrimination for SVI and positive lymph nodes. Discrimination of extraprostatic extension and organ confined disease was more limited. The Partin tables performed best in young men. |
3 |
| 10. Rayn KN, Bloom JB, Gold SA, et al. Added Value of Multiparametric Magnetic Resonance Imaging to Clinical Nomograms for Predicting Adverse Pathology in Prostate Cancer. J Urol. 200(5):1041-1047, 2018 11. |
Observational-Dx |
532 patients |
To examine the additional value of prostate mpMRI data and Tbx pathology data to the MSKCC4 and Partin3 nomograms to predict adverse pathological features on final pathology. |
When multiparametric magnetic resonance imaging findings were added to the systematic biopsy based MSKCC nomogram, the AUC increased by 0.10 for organ confined disease (p <0.001), 0.10 for extraprostatic extension (p = 0.003), 0.09 for seminal vesicle invasion (p = 0.011) and 0.06 for lymph node involvement (p = 0.120). Using Gleason scores derived from targeted biopsy compared to systematic biopsy provided an additional predictive value of organ confined disease (? AUC 0.07, p = 0.003) and extraprostatic extension (? AUC 0.07, p = 0.048) at radical prostatectomy with the MSKCC nomogram. Similar results were obtained using the Partin nomogram. |
3 |
| 11. Sandeman K, Eineluoto JT, Pohjonen J, et al. Prostate MRI added to CAPRA, MSKCC and Partin cancer nomograms significantly enhances the prediction of adverse findings and biochemical recurrence after radical prostatectomy. PLoS ONE. 15(7):e0235779, 2020. |
Observational-Dx |
387 patients |
To determine the added value of preoperative prostate multiparametric MRI (mpMRI) supplementary to clinical variables and their role in predicting post prostatectomy adverse findings and biochemically recurrent cancer (BCR). |
Clinical variables alone, MSKCC nomogram or Partin tables were outperformed by models with mpMRI for the prediction of any adverse finding at RP. AUC for clinical parameters versus clinical parameters and mpMRI variables were 0.77 versus 0.82 for any adverse finding. For MSKCC nomogram versus MSKCC nomogram and mpMRI variables the AUCs were 0.71 and 0.78 for any adverse finding. For Partin tables versus Partin tables and mpMRI variables the AUCs were 0.62 and 0.73 for any adverse finding. |
3 |
| 12. Greene DJ, Elshafei A, Nyame YA, et al. External validation of a PCA-3-based nomogram for predicting prostate cancer and high-grade cancer on initial prostate biopsy. Prostate. 76(11):1019-23, 2016 08. |
Observational-Dx |
336 patients |
To externally validate a previously developed PCA3-based nomogram for the prediction of prostate cancer (PCa) and high-grade (intermediate and/or high-grade) prostate cancer (HGPCa) at the time of initial prostate biopsy. |
Biopsy confirms PCa and HGPCa in 51.0% and 30.4% of validation patients, respectively. This differed from the original cohort in that it had significantly more PCa and HGPCA (51% vs. 44%, P = 0.019; and 30.4% vs. 19.1%, P < 0.001). Despite the differences in PCa detection the concordance index was 75% and 77% for overall PCa and HGPCa, respectively. |
3 |
| 13. Punnen S, Nahar B, Soodana-Prakash N, et al. Optimizing patient's selection for prostate biopsy: A single institution experience with multi-parametric MRI and the 4Kscore test for the detection of aggressive prostate cancer. PLoS ONE. 13(8):e0201384, 2018. |
Observational-Dx |
300 men |
To evaluate the performance of mpMRI and the 4Kscore test together for the detection of significant prostate cancer. |
Among 300 men who underwent a 4Kscore test and mpMRI, 149 (49%) underwent a biopsy. Among those, 73 (49%) had cancer, and 49 (33%) had Gleason 7 cancer. The area under the curve (AUC) for using the 4Kscore test and mpMRI together 0.82 (0.75-0.89) was superior to using the 4Kscore 0.70 (0.62-0.79) or mpMRI 0.74 (0.66-0.81) individually (p = 0.001). Similarly, decision analysis revealed the highest net benefit was achieved using both tests. |
3 |
| 14. Palsdottir T, Nordstrom T, Aly M, et al. A Unified Prostate Cancer Risk Prediction Model Combining the Stockholm3 Test and Magnetic Resonance Imaging. Eur Urol Oncol. 2(5):490-496, 2019 09. |
Observational-Dx |
532 men |
To develop a unified risk prediction model (S3M-MRI) that combines the Stockholm3 score (based on protein and genetic markers and clinical variables) and Prostate Imaging-Reporting and Data System v.2 scores modified for MRI without contrast (modPI-RADS). |
The area under the receiver operating characteristic curve (AUC) was 0.88 (95% confidence interval [CI] 0.85-0.91) for S3M-MRI, which was significantly higher (p=0.04) than for Stockholm3 (0.86, 95% CI 0.83-0.89) and modPI-RADS (0.83, 95% CI 0.79-0.87). S3M-MRI had a higher net benefit on decision curve analysis for clinically relevant probability thresholds for biopsy recommendation in comparison to Stockholm3 and modPI-RADS. However, for different diagnostic strategies, sequential use of Stockholm3 followed by MRI only for Stockholm3-positive men resulted in a similar number of unnecessary biopsies (64 vs 69) and diagnosed International Society of Urological Pathology (ISUP) grade group 1 cancers (56 vs 51) at similar sensitivity for ISUP grade group =2 cancers, while avoiding 38% of MRI scans. |
3 |
| 15. Fenstermaker M, Mendhiratta N, Bjurlin MA, et al. Risk Stratification by Urinary Prostate Cancer Gene 3 Testing Before Magnetic Resonance Imaging-Ultrasound Fusion-targeted Prostate Biopsy Among Men With No History of Biopsy. Urology. 99:174-179, 2017 Jan. |
Observational-Dx |
187 men |
To determine whether a combination of prostate cancer gene 3 (PCA3) and magnetic resonance imaging (MRI) suspicion score (mSS) could further optimize detection of prostate cancer on MRI fusion-targeted biopsy (MRF-TB) among men with no history of biopsy. |
PCA3 is associated with cancer detection on MRF-TB for men with no prior biopsies (area under the curve: 0.67, 95% confidence interval: 0.59-0.76). Using a cutoff of =35, PCA3 was associated with cancer risk among men with mSS 2-3 (P = .004), but not among those with mSS 4-5 (P = .340). The interaction of PCA3 and mSS demonstrated significantly higher discrimination for cancer than mSS alone (area under the curve: 0.83 vs 0.79, P = .0434). |
3 |
| 16. Duffy MJ.. Biomarkers for prostate cancer: prostate-specific antigen and beyond. [Review]. Clin Chem Lab Med. 58(3):326-339, 2020 02 25. |
Review/Other-Dx |
N/A |
To provide an updated and critical review on the role of PSA in prostate cancer screening, risk stratification, follow-up and monitoring therapy. |
No results stated in abstract. |
4 |
| 17. Lamy PJ, Allory Y, Gauchez AS, et al. Prognostic Biomarkers Used for Localised Prostate Cancer Management: A Systematic Review. Eur Urol Focus. 4(6):790-803, 2018 12. |
Review/Other-Dx |
58 studies |
To evaluate the clinical validity, level of evidence (LOE) for, and potential clinical utility of six prognostic prognostic biomarkers (PHI, 4Kscore, MiPS, GPS, Prolaris, Decipher). |
No results stated in abstract. |
4 |
| 18. Bjurlin MA, Rosenkrantz AB, Beltran LS, Raad RA, Taneja SS. Imaging and evaluation of patients with high-risk prostate cancer. Nat Rev Urol. 2015;12(11):617-628. |
Review/Other-Dx |
N/A |
To describe the various imaging modalities used to evaluate high-risk prostate cancer patients. |
While established prostate cancer staging guidelines have increased the appropriate use of imaging, underuse for high-risk prostate cancer remains substantial. Several factors affect the utility of initial diagnostic imaging, including the variable definition of high-risk prostate cancer, variable guideline recommendations, poor accuracy of existing imaging tests, and the difficulty in validating imaging findings. Conventional imaging modalities, including CT and radionuclide bone scan, have been employed for local and metastatic staging, but their performance characteristics have generally been poor. Emerging modalities including multiparametricMRI, positron emission tomography (PET)-CT, and PET-MRI have shown increased diagnostic accuracy and could improve accuracy in staging patients with high-risk prostate cancer. |
4 |
| 19. Hicks RM, Simko JP, Westphalen AC, et al. Diagnostic Accuracy of 68Ga-PSMA-11 PET/MRI Compared with Multiparametric MRI in the Detection of Prostate Cancer. Radiology. 289(3):730-737, 2018 12. |
Observational-Dx |
32 patients |
To compare the diagnostic accuracy of gallium 68 (68Ga)-labeled prostate-specific membrane antigen (PSMA)-11 PET/MRI with that of multiparametric MRI in the detection of prostate cancer. |
The region-specific sensitivities of PET/MRI and multiparametric MRI were 74% (95% confidence interval [CI]: 70%, 77%) and 50% (95% CI: 45%, 0.54%), respectively, with the alternative neighboring approach (P < .001 for both) and 73% (95% CI: 68%, 79%) and 69% (95% CI: 62%, 75%), respectively, with the population-averaged generalized estimating equation (P = .04). Region-specific specificity of PET/MRI was similar to that of multiparametric MRI with the alternative neighboring approach (88% [95% CI: 85%, 91%] vs 90% [95% CI: 87%, 92%], P = .99) and in population-averaged estimates (70% [95% CI: 64%, 76%] vs 70% [95% CI: 64%, 75%], P = .99). SUVmax was associated with a Gleason score of 7 and higher (odds ratio: 1.71 [95% CI: 1.27, 2.31], P < .001). |
2 |
| 20. Sandhu GS, Andriole GL. Overdiagnosis of prostate cancer. J Natl Cancer Inst Monogr. 2012;2012(45):146-151. |
Review/Other-Dx |
N/A |
To address issues relevant to prostate cancer over-diagnosis. |
No results stated in abstract. |
4 |
| 21. Schroder FH, Hugosson J, Roobol MJ, et al. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet. 2014;384(9959):2027-2035. |
Experimental-Tx |
72,891 intervention group and 89,352 control group |
To provide updated results of mortality from prostate cancer with follow-up to 2010, with analyses truncated at 9, 11, and 13 years. |
With data truncated at 13 years of follow-up, 7408 prostate cancer cases were diagnosed in the intervention group and 6107 cases in the control group. The rate ratio of prostate cancer incidence between the intervention and control groups was 1.91 (95% CI 1.83-1.99) after 9 years (1.64 [1.58-1.69] including France), 1.66 (1.60-1.73) after 11 years, and 1.57 (1.51-1.62) after 13 years. The rate ratio of prostate cancer mortality was 0.85 (0.70-1.03) after 9 years, 0.78 (0.66-0.91) after 11 years, and 0.79 (0.69-0.91) at 13 years. The absolute risk reduction of death from prostate cancer at 13 years was 0.11 per 1000 person-years or 1.28 per 1000 men randomised, which is equivalent to one prostate cancer death averted per 781 (95% CI 490-1929) men invited for screening or one per 27 (17-66) additional prostate cancer detected. After adjustment for non-participation, the rate ratio of prostate cancer mortality in men screened was 0.73 (95% CI 0.61-0.88). |
1 |
| 22. Hugosson J, Roobol MJ, Mansson M, et al. A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer. Eur Urol. 76(1):43-51, 2019 07. |
Observational-Dx |
162,241 patients |
To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended. |
The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently. |
2 |
| 23. Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 378(19):1767-1777, 2018 May 10. |
Experimental-Dx |
500 men |
To compare MRI-targeted biopsy with standard transrectal ultrasonography–guided biopsy in a pragmatic, multicenter, randomized trial. |
A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer,so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P = 0.005). MRI, with or without targeted biopsy, was non inferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001). |
2 |
| 24. van der Leest M, Cornel E, Israel B, et al. Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naive Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study. Eur Urol. 75(4):570-578, 2019 04. |
Observational-Dx |
626 biopsy-naïve patients |
To compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biopsy-naïve men with prostate-specific antigen levels of =3ng/ml. |
The MRI pathway detected csPCa in 159/626 (25%) patients and insignificant prostate cancer (insignPCa) in 88/626 patients (14%). TRUSGB detected csPCa in 146/626 patients (23%) and insignPCa in 155/626 patients (25%). Relative sensitivity of the MRI pathway versus the TRUSGB pathway was 1.09 for csPCa (p=0.17) and 0.57 for insignPCa (p<0.0001). The total number of biopsy cores reduced from 7512 to 849 (-89%). The MRI pathway enabled biopsy avoidance in 309/626 (49%) patients due to nonsuspicious mpMRI. Immediate TRUSGB detected csPCa in only 3% (10/309) of these patients, increasing to 4% (13/309) with 1-yr follow-up. At the same time, TRUSGB would overdetect insignPCa in 20% (63/309). "Focal saturation" by four additional perilesional cores to MRGB improved the detection of csPCa in 21/317 (7%) patients. Compared with the literature, our proportion of nonsuspicious mpMRI cases is significantly higher (27-36% vs 49%) and that of equivocal cases is lower (15-28% vs 6%). |
1 |
| 25. Rouviere O, Puech P, Renard-Penna R, et al. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 20(1):100-109, 2019 01. |
Observational-Dx |
224 in the per-protocol population |
To present the results of the MRI-FIRST trial, a prospective multicentre study in biopsy-naive patients that compared, in the same patients, the detection of ISUP grade group 2 or higher cancers, obtained by 12–14 core systematic biopsy and 3–6 core targeted biopsy. |
53 (21%) of 251 analysed patients had negative (Likert =2) multiparametric MRI. csPCa-A was detected in 94 (37%) of 251 patients. 13 (14%) of these 94 patients were diagnosed by systematic biopsy only, 19 (20%) by targeted biopsy only, and 62 (66%) by both techniques. Detection of csPCa-A by systematic biopsy (29·9%, 95% CI 24·3-36·0) and targeted biopsy (32·3%, 26·5-38·4) did not differ significantly (p=0·38). csPCa-A would have been missed in 5·2% (95% CI 2·8-8·7) of patients had systematic biopsy not been done, and in 7·6% (4·6-11·6) of patients had targeted biopsy not been done. Four grade 3 post-biopsy adverse events were reported (3 cases of prostatitis, and 1 case of urinary retention with haematuria). |
1 |
| 26. Ahdoot M, Wilbur AR, Reese SE, et al. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 382(10):917-928, 2020 03 05. |
Observational-Dx |
2103 men |
To assess the use of MRI-targeted, systematic, or combined prostate biopsy in an attempt to define the most effective method for prostate cancer diagnosis. |
A total of 2103 men underwent both biopsy methods; cancer was diagnosed in 1312 (62.4%) by a combination of the two methods (combined biopsy), and 404 (19.2%) underwent radical prostatectomy. Cancer detection rates on MRI-targeted biopsy were significantly lower than on systematic biopsy for grade group 1 cancers and significantly higher for grade groups 3 through 5 (P<0.01 for all comparisons). Combined biopsy led to cancer diagnoses in 208 more men (9.9%) than with either method alone and to upgrading to a higher grade group in 458 men (21.8%). However, if only MRI-target biopsies had been performed, 8.8% of clinically significant cancers (grade group =3) would have been misclassified. Among the 404 men who underwent subsequent radical prostatectomy, combined biopsy was associated with the fewest upgrades to grade group 3 or higher on histopathological analysis of surgical specimens (3.5%), as compared with MRI-targeted biopsy (8.7%) and systematic biopsy (16.8%). |
3 |
| 27. Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 389(10071):815-822, 2017 02 25. |
Observational-Dx |
576 men |
To test diagnostic accuracy of MP-MRI and TRUS-biopsy against a reference test (template prostate mapping biopsy [TPM-biopsy]). |
On TPM-biopsy, 408 (71%) of 576 men had cancer with 230 (40%) of 576 patients clinically significant. For clinically significant cancer, MP-MRI was more sensitive (93%, 95% CI 88-96%) than TRUS-biopsy (48%, 42-55%; p<0·0001) and less specific (41%, 36-46% for MP-MRI vs 96%, 94-98% for TRUS-biopsy; p<0·0001). 44 (5·9%) of 740 patients reported serious adverse events, including 8 cases of sepsis. |
1 |
| 28. Drost FH, Osses DF, Nieboer D, et al. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 4:CD012663, 2019 04 25. |
Meta-analysis |
18 studies |
To determine the diagnostic accuracy of the index tests MRI only, MRI-targeted biopsy, the MRI pathway (MRI with or without MRI-targeted biopsy) and systematic biopsy as compared to template-guided biopsy as the reference standard in detecting clinically significant prostate cancer as the target condition, defined as International Society of Urological Pathology (ISUP) grade 2 or higher. |
MRI compared to template-guided biopsy: Based on a pooled sensitivity of 0.91 (95% confidence interval (CI): 0.83 to 0.95; 12 studies; low certainty of evidence) and a pooled specificity of 0.37 (95% CI: 0.29 to 0.46; 12 studies; low certainty of evidence) using a baseline prevalence of 30%, MRI may result in 273 (95% CI: 249 to 285) true positives, 441 false positives (95% CI: 378 to 497), 259 true negatives (95% CI: 203 to 322) and 27 (95% CI: 15 to 51) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency.MRI-targeted biopsy compared to template-guided biopsy: Based on a pooled sensitivity of 0.80 (95% CI: 0.69 to 0.87; 8 studies; low certainty of evidence) and a pooled specificity of 0.94 (95% CI: 0.90 to 0.97; 8 studies; low certainty of evidence) using a baseline prevalence of 30%, MRI-targeted biopsy may result in 240 (95% CI: 207 to 261) true positives, 42 (95% CI: 21 to 70) false positives, 658 (95% CI: 630 to 679) true negatives and 60 (95% CI: 39 to 93) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency.The MRI pathway compared to template-guided biopsy: Based on a pooled sensitivity of 0.72 (95% CI: 0.60 to 0.82; 8 studies; low certainty of evidence) and a pooled specificity of 0.96 (95% CI: 0.94 to 0.98; 8 studies; low certainty of evidence) using a baseline prevalence of 30%, the MRI pathway may result in 216 (95% CI: 180 to 246) true positives, 28 (95% CI: 14 to 42) false positives, 672 (95% CI: 658 to 686) true negatives and 84 (95% CI: 54 to 120) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations, inconsistency and imprecision.Systemic biopsy compared to template-guided biopsy: Based on a pooled sensitivity of 0.63 (95% CI: 0.19 to 0.93; 4 studies; low certainty of evidence) and a pooled specificity of 1.00 (95% CI: 0.91 to 1.00; 4 studies; low certainty of evidence) using a baseline prevalence of 30%, systematic biopsy may result in 189 (95% CI: 57 to 279) true positives, 0 (95% CI: 0 to 63) false positives, 700 (95% CI: 637 to 700) true negatives and 111 (95% CI: 21 to 243) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency.Agreement analyses: In a mixed population of both biopsy-naïve and prior-negative biopsy men comparing the MRI pathway to systematic biopsy, we found a pooled detection ratio of 1.12 (95% CI: 1.02 to 1.23; 25 studies). We found pooled detection ratios of 1.44 (95% CI 1.19 to 1.75; 10 studies) in prior-negative biopsy men and 1.05 (95% CI: 0.95 to 1.16; 20 studies) in biopsy-naïve men. |
Good |
| 29. Moore CM, Robertson NL, Arsanious N, et al. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol 2013;63:125-40. |
Review/Other-Dx |
50 reports |
To systematically review the literature to compare the accuracy of MRI-targeted biopsy with standard transrectal biopsy in the detection of clinically significant prostate cancer. |
Evidence synthesis was used to address specific questions. Where MRI was applied to all biopsy-naive men, 62% (374 of 599) had MRI abnormalities. When subjected to a targeted biopsy, 66% (248 of 374) had prostate cancer detected. Both targeted and standard biopsy detected clinically significant cancer in 43% (236 or 237 of 555, respectively). Missed clinically significant cancers occurred in 13 men using targeted biopsy and 12 using a standard approach. Targeted biopsy was more efficient. A third fewer men were biopsied overall. Those who had biopsy required a mean of 3.8 targeted cores compared with 12 standard cores. A targeted approach avoided the diagnosis of clinically insignificant cancer in 53 of 555 (10%) of the presenting population. |
4 |
| 30. Woo S, Suh CH, Eastham JA, et al. Comparison of Magnetic Resonance Imaging-stratified Clinical Pathways and Systematic Transrectal Ultrasound-guided Biopsy Pathway for the Detection of Clinically Significant Prostate Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Eur Urol Oncol. 2(6):605-616, 2019 11. |
Meta-analysis |
Nine RCTs (2908 patients) were included. |
To perform a systematic review and meta-analysis of RCTs comparing the detection rates of csPCa in the MRI-stratified pathway and the systematic TRUS-Bx pathway in patients with a suspicion of prostate cancer (PCa). |
The MRI-stratified pathway detected more csPCa than the TRUS-Bx pathway (relative detection rate 1.45 [95% confidence interval {CI} 1.09-1.92] for all patients, and 1.42 [95% CI 1.02-1.97] and 1.60 [95% CI 1.01-2.54] for biopsy-naïve and prior negative biopsy patients, respectively). Detection rates were not significantly different between pathways for cisPCa (0.89 [95% CI 0.49-1.62]), but higher in the MRI-stratified pathway for the detection of any PCa (1.39 [95% CI 1.05-1.84]). |
Good |
| 31. Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Shear-Wave Elastography for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-Analysis. [Review]. AJR Am J Roentgenol. 209(4):806-814, 2017 Oct. |
Meta-analysis |
8 studies |
To review the diagnostic performance of shear-wave elastography (SWE) in the detection of prostate cancer (PCa). |
The pooled sensitivity was 0.83 (95% CI, 0.66-0.92) with a specificity of 0.85 (95% CI, 0.78-0.90) for the detection of PCa. Study design (prospective vs retrospective) was the only significant factor affecting heterogeneity (p < 0.01). At subgroup analysis, the pooled sensitivity and specificity were 0.84 (95% CI, 0.64-0.94) and 0.84 (95% CI, 0.76-0.90), respectively, in studies using shear-wave speed imaging and 0.84 (95% CI, 0.64-0.94) and 0.86 (95% CI, 0.78-0.91), respectively, in studies based on per-lesion analysis. |
Good |
| 32. Boehm K, Tennstedt P, Beyer B, et al. Additional elastography-targeted biopsy improves the agreement between biopsy Gleason grade and Gleason grade at radical prostatectomy. World J Urol. 34(6):805-10, 2016 Jun. |
Observational-Dx |
259 patients |
To assess whether real-time elastography-targeted biopsy (RTE-bx) may help to correctly assign Gleason grade at radical prostatectomy (RP) and to compare discriminant properties of systematic biopsy alone (sbx) versus combination with RTE-bx (comb-bx) to distinguish between postoperatively favorable (Gleason 3 + 3, pT2, Nx/0) and postoperatively unfavorable (Gleason =4 + 4) prostate cancer (PCa) at RP. |
Comb-bx resulted in higher correct overall Gleason assignment (68.3 vs. 56.7 %, p = 0.008) than sbx. Similarly, lower rates of undergrading (21.2 vs. 36.3 %, p < 0.001) were recorded. Specificity gains with comb-bx were 10 % (92 vs. 82 %, p = 0.004) for postoperatively favorable PCa. Comb-bx resulted in 31 % sensitivity gains relative to sbx (94 vs. 63 %, p = 0.03), when postoperatively unfavorable PCa was the endpoint. |
3 |
| 33. Lughezzani G, Saita A, Lazzeri M, et al. Comparison of the Diagnostic Accuracy of Micro-ultrasound and Magnetic Resonance Imaging/Ultrasound Fusion Targeted Biopsies for the Diagnosis of Clinically Significant Prostate Cancer. Eur Urol Oncol. 2(3):329-332, 2019 05. |
Observational-Dx |
56 patients |
To compare the diagnostic accuracy of micro-US targeted biopsies (index test) and MRI/US fusion targeted biopsies (reference standard test) in detecting clinically significant prostate cancer (csPC), defined as Gleason =7 disease, in a prospectively collected cohort of 104 patients with suspected PC defined according to prostate-specific antigen, digital rectal examination, and the presence of at least one Prostate Imaging-Reporting and Data System =3 lesion at mpMRI. |
PC was diagnosed in 56 patients (54%) and csPC in 35 (34%). Micro-US sensitivity for csPC detection was 94%, with 33/35 csPC cases correctly identified. The negative predictive value was 90%, while the positive predictive value was 40% and the specificity was 28%. Of the 61 targeted zones concordant between micro-US and mpMRI, 24 were csPC. |
3 |
| 34. Mannaerts CK, Wildeboer RR, Remmers S, et al. Multiparametric Ultrasound for Prostate Cancer Detection and Localization: Correlation of B-mode, Shear Wave Elastography and Contrast Enhanced Ultrasound with Radical Prostatectomy Specimens. J Urol. 202(6):1166-1173, 2019 12. |
Observational-Dx |
48 patients |
To determine the diagnostic performance of B-mode, shear wave elastography and contrast enhanced ultrasound with quantification software as well as the combination, multiparametric ultrasound, for clinically significant prostate cancer localization using radical prostatectomy histopathology as the reference standard. |
The region of interest specific sensitivity of multiparametric ultrasound (Likert 3 or greater) for clinically significant prostate cancer was 74% (95% CI 67-80) compared to 55% (95% CI 47-63), 55% (95% CI 47-63) and 59% (95% CI 51-67) for B-mode, shear wave elastography and contrast enhanced ultrasound, respectively. Multiparametric ultrasound sensitivity was significantly higher for Likert thresholds and all different clinically significant prostate cancer definitions (all p <0.05). |
3 |
| 35. Baur ADJ, Schwabe J, Rogasch J, et al. A direct comparison of contrast-enhanced ultrasound and dynamic contrast-enhanced magnetic resonance imaging for prostate cancer detection and prediction of aggressiveness. Eur Radiol. 28(5):1949-1960, 2018 May. |
Observational-Dx |
92 patients |
To evaluate if CEUS can provide comparable information as DCE-MRI for the detection of prostate cancer (PCa) and prediction of its aggressiveness. |
In peripheral zone lesions of all tested CEUS parameters only time to peak (TTPCEUS) showed significant differences between benign lesions and PCa (AUC 0.65). Of all tested DCE-MRI parameters, rate constant (Kep) was the best discriminator of high-grade PCa in the whole prostate (AUC 0.83) and in peripheral zone lesions (AUC 0.89). |
3 |
| 36. Trabulsi EJ, Calio BP, Kamel SI, et al. Prostate Contrast Enhanced Transrectal Ultrasound Evaluation of the Prostate With Whole-Mount Prostatectomy Correlation. Urology. 133:187-191, 2019 Nov. |
Observational-Dx |
58 pa |
To investigate the diagnostic accuracy of contrast enhanced transrectal ultrasound (CE-TRUS) in comparison with whole-mount radical prostatectomy specimens. |
Among the 58 whole-mount specimens, a maximum Gleason score of 6 was identified in 29 subjects, a score of 7 was identified in 24 and a score of 8 was identified in 5. The Az for baseline TRUS parameters was 0.55 for grayscale, 0.61 for color Doppler and 0.59 for power Doppler. CE-TRUS parameters demonstrated significant increases in Az with the highest Az for CE-power Doppler (0.66) and flash replenishment imaging (0.64) (P = .04 for comparison to baseline). The combination of CE-power Doppler and flash replenishment imaging resulted in improved Az compared with baseline imaging (0.70 vs 0.59, P= .006). |
2 |
| 37. Heesakkers RA, Hovels AM, Jager GJ, et al. MRI with a lymph-node-specific contrast agent as an alternative to CT scan and lymph-node dissection in patients with prostate cancer: a prospective multicohort study. Lancet Oncol. 9(9):850-6, 2008 Sep. |
Experimental-Dx |
375 patients |
To compare the diagnostic accuracy of MRL with up-to-date multidetector CT (MDCT), and test the hypothesis that a negative MRL finding obviates the need for a PLND. |
61 of 375 (16%) patients had lymph-node metastases. Sensitivity was 34% (21 of 61; 95% CI 23-48) for MDCT and 82% (50 of 61; 70-90) for MRL (McNemar's test p<0.05). Specificity was 97% (303 of 314; 94-98) for MDCT and 93% (291 of 314; 89-95) for MRL. Positive predictive value (PPV) was 66% (21 of 32; 47-81) for MDCT and 69% (50 of 73; 56-79) for MRL. Negative predictive value (NPV) was 88% (303 of 343; 84-91) for MDCT and 96% (291 of 302; 93-98) for MRL (McNemar's test p<0.05). Of the 61 patients with lymph-node metastases, 50 were detected by MRL, of which 40 (80%) had metastases in normal-sized lymph nodes. The high sensitivity and NPV of MRL imply that in patients with a negative MRL, the chance of positive lymph nodes is less than 11/302 (4%). |
2 |
| 38. Birkhauser FD, Studer UE, Froehlich JM, et al. Combined ultrasmall superparamagnetic particles of iron oxide-enhanced and diffusion-weighted magnetic resonance imaging facilitates detection of metastases in normal-sized pelvic lymph nodes of patients with bladder and prostate cancer. Eur Urol. 64(6):953-60, 2013 Dec. |
Observational-Dx |
75 patients |
To prospectively assess the diagnostic accuracy of combined ultrasmall superparamagnetic particles of iron oxide (USPIO) MRI and diffusion-weighted (DW) MRI in staging of normal-sized pelvic LNs in bladder and/or prostate cancer patients. |
At histopathologic analysis, 2993 LNs (median: 39 LNs; range: 17-68 LNs per patient) with 54 LN metastases (1.8%) were found in 20 of 75 (27%) patients. Per-patient sensitivity and specificity for detection of LN metastases by the three readers ranged from 65% to 75% and 93% to 96%, respectively; sensitivity and specificity per pelvic side ranged from 58% to 67% and 94% to 97%, respectively. Median reading time for the combined USPIO-DW-MRI images was 9 min (range: 3-26 min). |
2 |
| 39. Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Diagnostic Performance of Prostate Imaging Reporting and Data System Version 2 for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-analysis. [Review]. Eur Urol. 72(2):177-188, 2017 08. |
Meta-analysis |
21 studies |
To review the diagnostic performance of PI-RADSv2 for the detection of PCa. |
The pooled sensitivity was 0.89 (95% confidence interval [CI] 0.86-0.92) with specificity of 0.73 (95% CI 0.60-0.83) for PCa detection. Proportion of patients with PCa, magnetic field strength, and reference standard were significant factors affecting heterogeneity (p<0.01). Multiple subgroup analyses showed consistent results. In six studies performing head-to-head comparison, PI-RADSv2 demonstrated higher pooled sensitivity of 0.95 (95% CI 0.85-0.98) compared with 0.88 (95% CI 0.80-0.93) for PI-RADSv1 (p=0.04). However, the pooled specificity was not significantly different (0.73 [95% CI 0.47-0.89] vs 0.75 [95% CI 0.36-0.94], respectively; p=0.90). |
Good |
| 40. Mertan FV, Greer MD, Shih JH, et al. Prospective Evaluation of the Prostate Imaging Reporting and Data System Version 2 for Prostate Cancer Detection. J Urol. 196(3):690-6, 2016 Sep. |
Observational-Dx |
116 lesions in 62 patients |
To evaluate the cancer detection rate at each overall PI-RADSv2 score. |
Histopathology revealed 55 of 116 (47.4%) cancers (17 Gleason 3+3, 16 Gleason 3+4, 6 Gleason 4+3, 12 Gleason 4+4, 3 Gleason 4+5 and 1 Gleason 5+4). Based on targeted biopsy on a per lesion basis, the overall cancer detection rates of PI-RADS 2, 3, 4 and 5 scores for all tumors was 22.2%, 15.8%, 29.8% and 78.1%, respectively. The cancer detection rate of PI-RADS 2, 3, 4 and 5 scores for Gleason 3+4 or greater tumors was 5.6%, 0%, 21.3% and 75%, respectively. Differences in the cancer detection rate between overall PI-RADS 4 and 5 scores were significant (p <0.001 for Gleason greater than 3+3 and Gleason 3+4 or greater cancers). |
3 |
| 41. Purysko AS, Bittencourt LK, Bullen JA, Mostardeiro TR, Herts BR, Klein EA. Accuracy and Interobserver Agreement for Prostate Imaging Reporting and Data System, Version 2, for the Characterization of Lesions Identified on Multiparametric MRI of the Prostate. AJR Am J Roentgenol. 209(2):339-349, 2017 Aug. |
Observational-Dx |
170 patients |
To measure the accuracy and interobserver agreement of the Prostate Imaging Reporting and Data System, version 2 (PI-RADSv2), for the characterization of prostate lesions on multiparametric MRI. |
The prevalence of clinically significant prostate cancer was 0.36 (61/170 patients). The AUCs for readers 1 and 2 were 0.871 and 0.882, respectively. The AUCs were greater for peripheral zone lesions than for transition zone lesions. When a PI-RADSv2 assessment category = 3 was considered positive, the agreement between readers was good overall (? = 0.63) and was fair for transition zone lesions (? = 0.53). When a PI-RADSv2 assessment category = 4 was considered positive, the agreement was excellent overall (? = 0.91) and was excellent for both peripheral zone lesions (? = 0.91) and transition zone lesions (? = 0.87). |
2 |
| 42. Greer MD, Shih JH, Barrett T, et al. All over the map: An interobserver agreement study of tumor location based on the PI-RADSv2 sector map. J Magn Reson Imaging. 48(2):482-490, 2018 08. |
Observational-Dx |
30 patients |
To evaluate interobserver agreement in defining prostate tumor location on mpMRI using the PI-RADSv2 sector map. |
Readers detected an average of 1.9 lesions per patient (range 1.6-2.3). 96.3% (335/348) of all lesions for all readers were scored PI-RADS =3. Readers defined a median of 2 (range 1-18) sectors per lesion. Agreement for detecting index lesions by screen shots was 83.7% (76.1%-89.9%) vs. 71.0% (63.1-78.3%) overlap agreement on the PI-RADS sector map (P < 0.001). Exact agreement for defining sectors of detected index lesions was only 21.2% (95% confidence interval [CI]: 14.4-27.7%) and rose to 49.0% (42.4-55.3%) when overlap was considered. Agreement on defining the same level of disease (ie, apex, mid, base) was 61.4% (95% CI 50.2-71.8%). |
2 |
| 43. Mussi TC, Yamauchi FI, Tridente CF, et al. Interobserver Agreement and Positivity of PI-RADS Version 2 Among Radiologists with Different Levels of Experience. Acad Radiol. 26(8):1017-1022, 2019 08. |
Observational-Dx |
160 biopsied lesions |
To evaluate interobserver agreement of Prostate Imaging Reporting and Data System (PI-RADS) v2 category among radiologists with different levels of experience. |
Coefficient of concordance according to categories was 0.71 considering both zones, 0.72 for peripheral zone (PZ) and 0.44 for peripheral zone (TZ). Agreement for PI-RADS score of 3 or greater was 0.48 in PZ and 0.57 in TZ. Tumor positivity rates were 54.3% and 66.0% for PI-RADS 3 + 1 and 4 for PZ, respectively; and 25.0 and 49.2% for PI-RADS 3 + 1 and 4 for TZ, respectively (p < 0.001 in both analysis). Lesions <10, 10-14, and =15 mm had 55.3%, 74.6%, and 93.5% of positivity rates for cancer in PZ (p = 0.002 and <0.001) and 26.7%, 56.5%, and 59.6% in TZ, respectively (p = 0.245 and 0.632). Sensitivities, specificities, and accuracies of magnetic resonance imaging for prostate cancer using PI-RADS v2 were 76%, 72%, and 74% for PZ; and 76%, 69%, and 71% for TZ, respectively. |
2 |
| 44. Moldovan PC, Van den Broeck T, Sylvester R, et al. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. [Review]. Eur Urol. 72(2):250-266, 2017 08. |
Meta-analysis |
48 studies included in qualitative synthesis, 8 also met criteria for meta-analysis |
To systematically review the literature assessing the negative predictive value (NPV) of mpMRI in patients with a suspicion of PCa. |
At patient level, the median prevalence was 50.4% (interquartile range [IQR], 36.4-57.7%) for overall cancer and 32.9% (IQR, 28.1-37.2%) for csPCa. The median mpMRI NPV was 82.4% (IQR, 69.0-92.4%) for overall cancer and 88.1% (IQR, 85.7-92.3) for csPCa. NPV significantly decreased when cancer prevalence increased, for overall cancer (r=-0.64, p<0.0001) and csPCa (r=-0.75, p=0.032). Eight studies fulfilled the inclusion criteria for meta-analysis. Seven reported results for overall PCa. When the overall PCa prevalence increased from 30% to 60%, the combined NPV estimates decreased from 88% (95% confidence interval [95% CI], 77-99%) to 67% (95% CI, 56-79%) for a cut-off score of 3/5. Only one study selected for meta-analysis reported results for Gleason =7 cancers, with a positive biopsy rate of 29.3%. The corresponding NPV for a cut-off score of =3/5 was 87.9%. |
Good |
| 45. Hansen NL, Barrett T, Koo B, et al. The influence of prostate-specific antigen density on positive and negative predictive values of multiparametric magnetic resonance imaging to detect Gleason score 7-10 prostate cancer in a repeat biopsy setting. BJU Int. 119(5):724-730, 2017 05. |
Observational-Dx |
514 patients |
To evaluate the influence of prostate-specific antigen density (PSAD) on positive (PPV) and negative (NPV) predictive values of multiparametric magnetic resonance imaging (mpMRI) to detect Gleason score =7 cancer in a repeat biopsy setting. |
Gleason score =7 cancer was detected in 31% of the men. The NPV of Likert 1-2 mpMRI was 0.91 (±0.04) with a PSAD of =0.2 ng/mL/mL and 0.71 (±0.16) with a PSAD of >0.2 ng/mL/mL (P = 0.003). For Likert 3 mpMRI, PPV was 0.09 (±0.06) with a PSAD of =0.2 ng/mL/mL and 0.44 (±0.19) with a PSAD of >0.2 ng/mL/mL (P = 0.002). PSAD also significantly affected the PPV of Likert 4-5 mpMRI lesions: the PPV was 0.47 (±0.08) with a PSAD of =0.2 ng/mL/mL and 0.66 (±0.10) with a PSAD of >0.2 ng/mL/mL (P < 0.001). |
3 |
| 46. Rosenkrantz AB, Shanbhogue AK, Wang A, Kong MX, Babb JS, Taneja SS. Length of capsular contact for diagnosing extraprostatic extension on prostate MRI: Assessment at an optimal threshold. J Magn Reson Imaging. 43(4):990-7, 2016 Apr. |
Observational-Dx |
90 patients |
To evaluate the length of capsular contact of dominant lesions on multiparametric prostate magnetic resonance imaging (MRI) for predicting extraprostatic extension (EPE) and to determine a threshold value to apply in clinical practice. |
The optimal thresholds were 6 mm and 7 mm of contact using T2 WI and ADC for any EPE, and 10 mm and 7 mm using T2 WI and ADC for nonfocal EPE (AUCs 81.0-82.5%). Capsular contact had higher sensitivity, yet lower specificity, than subjective interpretations for any EPE and for nonfocal EPE (all P = 0.018, aside from any EPE for R2 using ADC). Length of contact exhibited more substantial gains in sensitivity (9-20% for any EPE; 34-41% for nonfocal EPE) than losses in specificity (6-13% for any EPE; 17-27% for nonfocal EPE) compared with subjective interpretations. Interreader agreement: 0.70 for assessments based on length of contact; 0.49-0.59 for subjective assessments. |
2 |
| 47. Woo S, Kim SY, Cho JY, Kim SH. Length of capsular contact on prostate MRI as a predictor of extracapsular extension: which is the most optimal sequence?. Acta Radiol. 58(4):489-497, 2017 Apr. |
Observational-Dx |
185 patients |
To evaluate LCC using different MRI sequences for determining ECE in prostate cancer. |
There were no significant differences among LCCs ( P = 0.333-0.837). All LCCs were significantly greater in patients with ECE ( P < 0.001). The optimal threshold value for predicting ECE was >14, >13, >12, and >14 mm for LCCT2, LCCADC, LCCDCE, and LCCmax, respectively. LCCmax yielded the highest area under the curve (0.895) which was significantly greater than that by LCCADC (0.858, P = 0.030). Otherwise, there were no significant difference between LCCs ( P = 0.052-0.985). At univariate analysis, age, clinical stage, PSA, Gleason score, and all LCCs were significantly associated with ECE ( P < 0.001-0.040). At multivariate analysis, GS ( P = 0.008) and all LCCs ( P < 0.001) were independently predictive factors. |
3 |
| 48. Mehralivand S, Shih JH, Harmon S, et al. A Grading System for the Assessment of Risk of Extraprostatic Extension of Prostate Cancer at Multiparametric MRI. Radiology. 290(3):709-719, 2019 03. |
Observational-Dx |
553 participants |
To evaluate MRI features associated with pathologically defined extraprostatic extension (EPE) of prostate cancer and to propose an MRI grading system for pathologic EPE. |
Among 553 study participants, the mean age was 60 years ± 8 (standard deviation); the median prostate-specific antigen value was 6.3 ng/mL. A total of 125 of 553 (22%) participants had pathologic EPE at radical prostatectomy. Detection of pathologic EPE, defined as number of pathologic EPEs divided by number of participants with individual MRI features, was as follows: curvilinear contact length, 88 of 208 (42%); capsular bulge and irregularity, 78 of 175 (45%); and EPE visible at MRI, 37 of 56 (66%). For MRI, grades 1, 2, and 3 for detection of pathologic EPE were 18 of 74 (24%), 39 of 102 (38%), and 37 of 56 (66%), respectively. Clinical features plus the MRI-based EPE grading system (prostate-specific antigen, International Society of Urological Pathology stage, MRI grade) predicted pathologic EPE better than did MRI grade alone (AUC, 0.81 vs 0.77, respectively; P < .001). |
3 |
| 49. de Rooij M, Hamoen EH, Witjes JA, Barentsz JO, Rovers MM. Accuracy of Magnetic Resonance Imaging for Local Staging of Prostate Cancer: A Diagnostic Meta-analysis. Eur Urol. 2015:[E-pub ahead of print]. |
Meta-analysis |
75 studies including 9796 patients |
To assess the diagnostic accuracy of magnetic resonance imaging (MRI) for local PCa staging and explore the influence of different imaging protocols. |
A total of 75 studies (9796 patients) could be analysed. Pooled data for ECE (45 studies, 5681 patients), SVI (34 studies, 5677 patients), and overall stage T3 detection (38 studies, 4001 patients) showed sensitivity and specificity of 0.57 (95% confidence interval [CI] 0.49-0.64) and 0.91 (95% CI 0.88-0.93), 0.58 (95% CI 0.47-0.68) and 0.96 (95% CI 0.95-0.97), and 0.61 (95% CI 0.54-0.67) and 0.88 (95% CI 0.85-0.91), respectively. Functional imaging in addition to T2-weighted imaging and use of higher field strengths (3 T) improved sensitivity for ECE and SVI. ECE sensitivity was not improved by endorectal coil use. |
M |
| 50. Verma S, Turkbey B, Muradyan N, et al. Overview of dynamic contrast-enhanced MRI in prostate cancer diagnosis and management. AJR Am J Roentgenol. 2012;198(6):1277-1288. |
Review/Other-Dx |
N/A |
To provide a detailed summary of efforts to date in prostate DCE-MRI as well as to present a guide for performing DCE-MRI in patients with known or suspected prostate cancer. |
No results stated in abstract. |
4 |
| 51. Weinreb JC, Barentsz JO, Choyke PL, et al. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 69(1):16-40, 2016 Jan. |
Review/Other-Dx |
N/A |
To promote global standardization and diminish variation in the acquisition, interpretation, and reporting of prostate multiparametric magnetic resonance imaging (mpMRI) examination, and it is based on the best available evidence and expert consensus opinion. |
No results stated in abstract. |
4 |
| 52. Romero G, Foster BR, Pettersson DR, Fung AW, Guimaraes AR, Coakley FV. Endorectal multiparametric MRI of the prostate: incremental effect of perfusion imaging on biopsy target identification. Clin Imaging. 40(3):553-7, 2016 May-Jun. |
Observational-Dx |
52 patients |
To evaluate the incremental effect of perfusion imaging on biopsy target identification at endorectal multiparametric prostate magnetic resonance imaging (MRI). |
Reader 1 identified 36 targets without and 39 targets with perfusion imaging (P>.05). The corresponding numbers for reader 2 were 38 and 38, respectively (P=.5). |
2 |
| 53. Hotker AM, Mazaheri Y, Aras O, et al. Assessment of Prostate Cancer Aggressiveness by Use of the Combination of Quantitative DWI and Dynamic Contrast-Enhanced MRI. AJR Am J Roentgenol. 206(4):756-63, 2016 Apr. |
Observational-Dx |
158 men |
To investigate whether the apparent diffusion coefficient (ADC) value from DWI and the forward volume transfer constant (K(trans)) value from dynamic contrast-enhanced MRI independently predict prostate cancer aggressiveness, and to determine whether the combination of both parameters performs better than either parameter alone in assessing tumor aggressiveness before treatment. |
The median ADC and K(trans) values showed moderate correlation only for tumors for which the Gleason score (GS) was 4 + 4 or higher (? = 0.547; p = 0.042). The tumor ADC value was statistically significantly associated with all dichotomized GSs (p < 0.005), including a GS of 3 + 3 versus a GS of 3 + 4 or higher (AUC, 0.693; p = 0.001). The tumor K(trans) value differed statistically significantly only between tumors with a GS of 3 + 3 and those with a primary Gleason grade of 4 (p = 0.015), and it made a statistically significant contribution only in differentiating tumors with a GS of 4 + 3 or higher (AUC, 0.711; p < 0.001) and those with a GS of 4 + 4 or higher (AUC, 0.788; p < 0.001) from lower-grade tumors. Combining ADC and K(trans) values improved diagnostic performance in characterizing tumors with a GS of 4 + 3 or higher and those with a GS of 4 + 4 or higher (AUC, 0.739 and 0.856, respectively; p < 0.01). |
3 |
| 54. Woo S, Suh CH, Kim SY, Cho JY, Kim SH, Moon MH. Head-to-Head Comparison Between Biparametric and Multiparametric MRI for the Diagnosis of Prostate Cancer: A Systematic Review and Meta-Analysis. AJR Am J Roentgenol. 211(5):W226-W241, 2018 11. |
Meta-analysis |
22 studies (2142 patients) |
To perform a systematic review and meta-analysis of a head-to-head comparison between the performance of biparametric MRI (bpMRI; only T2-weighted imaging and DWI) and that of multiparametric MRI (mpMRI; T2-weighted imaging, DWI, dynamic contrast-enhanced MRI) for the diagnosis of prostate cancer. |
Twenty studies (2142 patients) were included. Pooled sensitivity and specificity were 0.74 (95% CI, 0.66-0.81) and 0.90 (95% CI, 0.86-0.93) for bpMRI and 0.76 (95% CI, 0.69-0.82) and 0.89 (95% CI, 0.85-0.93) for mpMRI. MRI protocol (bpMRI vs mpMRI) was not a significant factor in heterogeneity (p = 0.83). In 26 subgroups evaluated on the basis of stratification to clinicopathologic, study, and MRI characteristics, MRI protocol (bpMRI vs mpMRI) was not a significant factor in heterogeneity in any subgroup (p = 0.25-0.97). |
Good |
| 55. Klein EA. Prostate cancer: MR-TRUS fusion biopsy--defining a new standard. Nat Rev Clin Oncol. 2015;12(5):253-254. |
Observational-Dx |
N/A |
To (1) comment on a study published by Siddiqui et al and (2) explain how MR-TRUS fusion can address the shortcomings of current biopsy schemes. |
The widespread use of PSA screening and transrectal ultrasound (TRUS)-guided prostate biopsy has resulted in an epidemic of overdetection and overtreatment of prostate cancer. The use of targeted magnetic resonance (MR) and ultrasound fusion guided prostate biopsy promises to improve the detection rate of high-risk prostate cancer—reducing the issue of overdetection and overtreatment. |
4 |
| 56. Wysock JS, Rosenkrantz AB, Huang WC, et al. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014;66(2):343-351. |
Experimental-Dx |
125 men |
To prospectively compare targeted biopsy outcomes between MR imaging (MRI)-ultrasound fusion and visual targeting. |
Among 172 targets, fusion biopsy detected 55 (32.0%) cancers and 35 (20.3%) Gleason sum >/=7 cancers compared with 46 (26.7%) and 26 (15.1%), respectively, using visual targeting (p=0.1374, p=0.0523). Fusion biopsy provided informative nonbenign histology in 77 targets compared with 60 by visual (p=0.0104). Targeted biopsy detected 75.0% of all clinically significant cancers and 86.4% of Gleason sum >/=7 cancers detected on standard biopsy. On multivariate analysis, fusion performed best among smaller targets. The study is limited by lack of comparison with whole-gland specimens and sample size. Furthermore, cancer detection on visual targeting is likely higher than in community settings, where experience with this technique may be limited. |
2 |
| 57. Wegelin O, Exterkate L, van der Leest M, et al. The FUTURE Trial: A Multicenter Randomised Controlled Trial on Target Biopsy Techniques Based on Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer in Patients with Prior Negative Biopsies. Eur Urol. 75(4):582-590, 2019 04. |
Observational-Dx |
665 men |
To compare detection rates of overall PCa and clinically significant PCa (csPCa) for the three MRI-based TB techniques. |
On mpMRI, 234/665 (35%) patients had PIRADS =3 lesions and underwent TB. There were no significant differences in the detection rates of overall PCa (FUS-TB 49%, COG-TB 44%, MRI-TB 55%, p=0.4). PCa detection rate differences were -5% between FUS-TB and MRI-TB (p=0.5, 95% confidence interval [CI] -21% to 11%), 6% between FUS-TB and COG-TB (p=0.5, 95% CI -10% to 21%), and -11% between COG-TB and MRI-TB (p=0.17, 95% CI -26% to 5%). There were no significant differences in the detection rates of csPCa (FUS-TB 34%, COG-TB 33%, MRI-TB 33%, p>0.9). Differences in csPCa detection rates were 2% between FUS-TB and MRI-TB (p=0.8, 95% CI -13% to 16%), 1% between FUS-TB and COG-TB (p>0.9, 95% CI -14% to 16%), and 1% between COG-TB and MRI-TB (p>0.9, 95% CI -14% to 16%). The main study limitation was a low rate of PIRADS =3 lesions on mpMRI, causing underpowering for primary outcome. |
3 |
| 58. Hamid S, Donaldson IA, Hu Y, et al. The SmartTarget Biopsy Trial: A Prospective, Within-person Randomised, Blinded Trial Comparing the Accuracy of Visual-registration and Magnetic Resonance Imaging/Ultrasound Image-fusion Targeted Biopsies for Prostate Cancer Risk Stratification. Eur Urol. 75(5):733-740, 2019 05. |
Observational-Dx |
141 men |
To assess concordance between the two methods. |
The two strategies combined detected 93 clinically significant prostate cancers (72% of the cohort). Each strategy detected 80/93 (86%) of these cancers; each strategy identified 13 cases missed by the other. Three patients experienced adverse events related to biopsy (urinary retention, urinary tract infection, nausea, and vomiting). No difference in urinary symptoms, erectile function, or quality of life between baseline and follow-up (median 10.5 wk) was observed. The key limitations were lack of parallel-group randomisation and a limit on the number of targeted cores. |
2 |
| 59. Porreca A, Del Giudice F, Giampaoli M, et al. Adding systematic biopsy to magnetic resonance ultrasound fusion targeted biopsy of the prostate in men with previous negative biopsy or enrolled in active surveillance programs: A prospective single center, randomized study. Medicine (Baltimore). 99(37):e22059, 2020 Sep 11. |
Observational-Dx |
312 patients |
To investigate benefits in terms of detection rate and pathological stratification of prostate cancer (PCa) using contextual SBx during MRI-TBx. |
A total of 312 patients were included in the 2 cohorts (cohort A: 213 cases; cohort B: 99 cases). No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P?=?.36) and csPCa-DR (48.2% vs 60.9 respectively; P?=?.12). The MRI-TBx alone cohort showed higher csPCa/PCa ratio (87.5% vs 62.2%; P?=?.03). The MRI-TBx plus SBx group subanalysis showed significantly higher csPCa-DR obtained at the MRI-TBx cores when compared with the SBx cores (43.7% vs 24.1%, respectively; P?=?.01). Independently to age, prostatic-specific antigen and prostate imaging-reporting and data system score, either in rebiopsy (OR 0.43, 0.21–0.97) or AS (OR 0.46, 0.32–0.89) setting, SBx cores were negatively associated with the csPCa-DR when combined to TBx cores. |
2 |
| 60. Baco E, Rud E, Eri LM, et al. A Randomized Controlled Trial To Assess and Compare the Outcomes of Two-core Prostate Biopsy Guided by Fused Magnetic Resonance and Transrectal Ultrasound Images and Traditional 12-core Systematic Biopsy. Eur Urol. 69(1):149-56, 2016 Jan. |
Experimental-Dx |
183 patients |
To compare the rate of detection of clinically significant prostate cancer (csPCa) between the two groups. |
Detection rates for any cancer (MRI group 51/86, 59%; control group 48/89, 54%; p=0.4) and csPCa (38/86, 44% vs 44/89, 49%; p=0.5) did not significantly differ between the groups. Detection of csPCa was comparable between two-core MRI/TRUS-TB (33/86, 38%) and 12-core RB in the control group (44/89, 49%; p=0.2). In a subset analysis of patients with normal DRE, csPCa detection was similar between two-core MRI/TRUS-TB (14/66, 21%) and 12-core RB in the control group (15/60, 25%; p=0.7). Among biopsy-proven csPCas in MRI group, 87% (33/38) were detected by MRI/TRUS-TB. The definition of csPCa was only based on biopsy outcomes. |
2 |
| 61. Porpiglia F, Manfredi M, Mele F, et al. Diagnostic Pathway with Multiparametric Magnetic Resonance Imaging Versus Standard Pathway: Results from a Randomized Prospective Study in Biopsy-naive Patients with Suspected Prostate Cancer. Eur Urol. 72(2):282-288, 2017 08. |
Observational-Dx |
212 patients |
To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa. |
The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; p=0.002) and csPCa (43.9% vs 18.1%, respectively; p<0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; p<0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; p<0.001). The reproducibility of the study could have been affected by the single-center nature. |
1 |
| 62. Pessoa RR, Viana PC, Mattedi RL, et al. Value of 3-Tesla multiparametric magnetic resonance imaging and targeted biopsy for improved risk stratification in patients considered for active surveillance. BJU Int. 119(4):535-542, 2017 04. |
Observational-Dx |
105 patients |
To evaluate the role of multiparametric magnetic resonance imaging (mpMRI) of the prostate and transrectal ultrasonography guided biopsy (TRUS-Bx) with visual estimation in early risk stratification of patients with prostate cancer on active surveillance (AS). |
In all, 105 patients were available for analysis in the study. From this cohort, 42 (40%) had PI-RADS 1, 2, or 3 lesions and 63 (60%) had only grade 4 or 5 lesions. Overall, 87 patients underwent visual estimation TRUS-Bx. Reclassification among patients with PI-RADS 1, 2, 3, 4, and 5 was 0%, 23.1%, 9.1%, 74.5%, and 100%, respectively. Overall, mpMRI sensitivity, specificity, positive predictive value, and negative predictive value for disease reclassification were 92.5%, 76%, 81%, and 90.5%, respectively. In the multivariate analysis, only PSAD and mpMRI remained significant for reclassification (P < 0.05). In the cross-tabulation, SBx would have missed 15 significant cases detected by targeted biopsy, but SBx did detect five cases of significant cancer not detected by targeted biopsy alone. |
3 |
| 63. Jambor I, Bostrom PJ, Taimen P, et al. Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial). J Magn Reson Imaging. 46(4):1089-1095, 2017 10. |
Observational-Dx |
175 men |
To evaluate the role of a 3T biparametric magnetic resonance imaging (bpMRI), T2 -weighted imaging, and three separate diffusion-weighted imaging acquisitions combined with targeted biopsy (TB) for improving risk stratification of men with elevated prostate-specific antigen (PSA). |
TB compared with SB had higher CDR for SPCa (45%, 72/161 vs. 39%, 63/161, respectively; P > 0.05) and a lower CDR for Gleason score 3 + 3 (8%, 15/161 vs. 16%, 30/161; P < 0.05). Restricting biopsy to men with equivocal to highly suspicious bpMRI findings would have resulted in a 24% (38/161) reduction in the number of men undergoing biopsy, while missing 4 (2%) with SPCa. All anonymized datasets, including bpMRI reports and follow up information, are freely available on the trial server. |
3 |
| 64. Muthigi A, Sidana A, George AK, et al. Midline lesions of the prostate: role of MRI/TRUS fusion biopsy and implications in Gleason risk stratification. Int Urol Nephrol. 48(9):1445-52, 2016 Sep. |
Observational-Dx |
1266 patients |
To further study the utility of MRI/TRUS fusion-guided biopsy, we hypothesized that midline lesions may be undersampled with systematic 12-core biopsy, and that MRI/TRUS fusion-guided biopsy has added value in patients with midline lesions identified on mpMRI. |
Out of 1266 patients, we identified 202 suspicious midline lesions in 190 patients [median (IQR) age 63 (10) years; PSA 7.6 (6.6)]. Eighty-eight (46.3 %) patients had cancer detection on FBx of midline lesion. A midline target represented the index lesion of the prostate in 63/190 (33.2 %) patients. Risk category upgrading based on FBx of a midline lesion compared to SBx occurred in 45/190 patients (23.7 %). On multivariate analysis, higher PSA (p = .001), lower MRI-derived prostate volume (p < .001), and moderate–high or high suspicion on mpMRI (p = .014) predicted CS cancer in midline lesions. |
3 |
| 65. Smeenge M, de la Rosette JJ, Wijkstra H. Current status of transrectal ultrasound techniques in prostate cancer. Curr Opin Urol. 2012;22(4):297-302. |
Review/Other-Dx |
N/A |
To present the current status of transrectal ultrasound imaging in prostate cancer (PCa) and discuss the latest techniques now under preclinical evaluation. |
Three-dimensional ultrasound and quantification techniques are superior to two-dimensional ultrasound in visualizing PCa and can be beneficial in staging prior to operation. Doppler-guided biopsies are more likely to yield positive results, especially when high Gleason scores are present. Furthermore, Vardenafil usage strengthens Doppler enhancement and can help in increasing the diagnostic accuracy of Doppler. Multiple studies show elastography to be a promising new addition to the ultrasound investigations for detection of PCa. Especially the recently introduced Shear Wave Elastography shows decreased user dependency and increased PCa detection rates. MRI can also aid in the diagnostics of PCa. However, MRI-guided biopsies are more complicated compared to ultrasound guidance. MRI/ultrasound fusion combines best of both techniques and, although just recently emerged, the studies available show promising PCa detection rates. |
4 |
| 66. Steinkohl F, Luger AK, Pichler R, et al. Visibility of MRI prostate lesions on B-mode transrectal ultrasound. Med. ultrasonography. 20(4):441-445, 2018 Dec 08. |
Observational-Dx |
180 patients |
To further assess the visibility of mpMRI lesions on B TRUS in a larger cohort and to identify factors influencing visibility of mpMRI lesions on B TRUS |
Overall 92 from 148 mpMRI lesions (62.2%) were visible on B TRUS. The location of the lesion in the prostate, the PIRADS classification of the lesions and the size of the lesion had no significant influence on the visibility on B TRUS. Only the prostate volume had a significant influence on visibility: in smaller prostates significantly more lesions were visible on B TRUS than in large glands (p+0.041; 45.1 ml vs 54 ml). |
3 |
| 67. Onur R, Littrup PJ, Pontes JE, Bianco FJ, Jr. Contemporary impact of transrectal ultrasound lesions for prostate cancer detection. J Urol. 2004;172(2):512-514. |
Observational-Dx |
3,912 |
To study whether the predictability of a biopsy core changes if the tissue comes from an isoechoic vs hypoechoic lesion. |
A total of 31,296 cores were obtained from the cohort. Overall 2,642 (68%) cores had at least 1 hypoechoic lesion ultrasonographically. Cancer was detected in 675 (25.5%) and 323 (25.4%) patients with or without hypoechoic lesions (p = 0.97). The per core cancer detection was fairly uniform and averaged 9.3% and 10.4% for hypoechoic and isoechoic areas, respectively. The difference was not statistically significant (p = 0.3). Gleason scores were less than 7, 7 and greater than 7 in 46%, 34% and 20% of cases, respectively. |
3 |
| 68. Hodge KK, McNeal JE, Terris MK, Stamey TA. Random systematic versus directed ultrasound guided transrectal core biopsies of the prostate. J Urol. 1989;142(1):71-74; discussion 74-75. |
Observational-Dx |
136 patients |
To examine the possibility that random systematic biopsies from the apex to the base in the peripheral and central zones of both prostatic lobes may be a better method to detect posteriorly located cancers than concentrating upon specific hypo-echoic defects. |
Prostate cancer was diagnosed in 83 of 136 patients (62 per cent). In 80 of 83 individuals (94 per cent) the cancer was detected by random systematic biopsies alone. Of 57 men in whom random systematic and directed biopsies were obtained the results of biopsy agreed in 86 per cent, while in 9 per cent random systematic biopsies found cancers missed by directed biopsies and in 5 per cent directed biopsies diagnosed cancers missed by random systematic prostate biopsies. |
4 |
| 69. Dominguez-Escrig JL, McCracken SR, Greene D. Beyond diagnosis: evolving prostate biopsy in the era of focal therapy. Prostate Cancer. 2011;2011:386207. |
Review/Other-Dx |
N/A |
To review the evolution of prostatic biopsy and current controversies. |
Despite decades of use as the "gold standard" in the detection of prostate cancer, the optimal biopsy regimen is still not universally agreed upon. While important aspects such as the need for laterally placed biopsies and the importance of apical cancer are known, repeated studies have shown significant patients with cancer on subsequent biopsy when the original biopsy was negative and an ongoing suspicion of cancer remained. Attempts to maximise the effectiveness of repeat biopsies have given rise to the alternate approaches of saturation biopsy and the transperineal approach. Recent interest in focal treatment of prostate cancer has further highlighted the need for accurate detection of prostate cancer, and in response, the introduction of transperineal template-guided biopsy. While the saturation biopsy approach and the transperineal template approach increase the detection rate of cancer in men with a previous negative biopsy and appear to have acceptable morbidity, there is a lack of clinical trials evaluating the different biopsy strategies. |
4 |
| 70. Kvale R, Moller B, Wahlqvist R, et al. Concordance between Gleason scores of needle biopsies and radical prostatectomy specimens: a population-based study. BJU Int. 2009;103(12):1647-1654. |
Observational-Dx |
1,116 patients |
To study the concordance between the Gleason scores of needle biopsies and radical prostatectomy (RP) specimens in a population-based registry, to clarify whether the concordance depends on the annual number of RP specimens assessed in the pathology unit, and to identify preoperative clinical factors that predict upgrading from a Gleason score of <or=6 in the biopsy to >or=7 in the RP specimen. |
The Gleason scores were identical in biopsy and RP specimens in 591 of the 1116 (53%) patients. The biopsy-based Gleason score more often under-graded (38%) than over-graded (9%) the RP-based Gleason score. Pathology units that examined >40 RP specimens annually had a higher concordance between the Gleason score in the biopsy and RP specimen than did lower-volume units. The rate of upgrading from a Gleason score of <or=6 in the biopsy to >or=7 in the RP specimen increased with increasing preoperative prostate-specific antigen serum levels, and with increasing intervals between biopsy and RP. |
3 |
| 71. Porten SP, Whitson JM, Cowan JE, et al. Changes in prostate cancer grade on serial biopsy in men undergoing active surveillance. J Clin Oncol. 2011;29(20):2795-2800. |
Observational-Dx |
377 |
To further characterize the behavior of Gleason grade on serial biopsies over time in men undergoing active surveillance. |
Three hundred seventy-seven men met inclusion criteria. Mean age at diagnosis was 61.9 years. Fifty-three percent of men had prostate-specific antigen of 6 ng/mL or less, and 94% had Gleason score of 6 or less. A majority of men were cT1 (62%), had less than 33% of biopsy cores involved (80%), and were low risk (77%) at diagnosis. Median number of cores taken at diagnostic biopsy was 13, mean time to follow-up was 18.5 months, and 29% of men had three or more repeat biopsies. Overall, 34% (129 men) were found to have an increase in Gleason grade. The majority of men who experienced an upgrade (81%) did so by their second repeat biopsy. |
3 |
| 72. Shakir NA, Siddiqui MM, George AK, et al. Should Hypoechoic Lesions on Transrectal Ultrasound Be Sampled During Magnetic Resonance Imaging-targeted Prostate Biopsy?. Urology. 105:113-117, 2017 Jul. |
Observational-Dx |
1260 men |
To determine whether supplemental biopsy of hypoechoic ultrasound lesions (HUL) incidentally found during magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion-targeted prostate biopsy results in improved prostate cancer (PCa) detection. |
Of 1260 men in the trial, 106 underwent biopsy of 119 HULs. PCa was diagnosed in 52 out of 106 men (49%) by biopsy of either MRI lesions or HUL. Biopsy of HUL in addition to MRI lesions resulted in 4 additional diagnoses of high-grade (ISUP grades 3-5) PCa versus biopsy of MRI lesions alone (20 vs 16 men, P = .046). Three of these cases were upgraded from lower grade (ISUP grades 1-2) PCa on MRI-guided biopsy alone, and only 1 case (1% of cohort) was diagnosed that would have been missed by MRI-guided biopsy alone. Supplemental biopsy of HUL did not change the PCa risk category in 96% (102 out of 106) of men with HUL. |
2 |
| 73. Keetch DW, Catalona WJ, Smith DS. Serial prostatic biopsies in men with persistently elevated serum prostate specific antigen values. J Urol. 1994;151(6):1571-1574. |
Observational-Dx |
1,136 patients |
To determine the need for repeat prostatic biopsies in men whose initial biopsy results revealed no evidence of cancer or atypia. |
Of 427 men who had negative initial biopsy results, a persistent serum PSA level of greater than 4.0 ng./ml. and abnormal rectal or ultrasound examination findings 82 (19%) had cancer on biopsy 2. Of 203 men with persistent abnormalities 16 (8%) had cancer on biopsy 3 and 6 of 91 (7%) had cancer on biopsy 4 or later. Thus, 96% of the cancers were detected through either biopsy 1 or 2. The median initial PSA level, followup PSA levels and the yearly rate of change in PSA were significantly greater in men whose cancer was detected compared with those of men whose cancer was not detected (6.4 versus 5.4 ng./ml., 7.4 versus 6.6 ng./ml. and 1.1 versus 0.7 ng./ml. per year, respectively). There was a trend for a higher percentage of tumors detected through serial screening to be pathologically organ confined with those detected through initial screening (73% versus 62%, p = 0.07). |
3 |
| 74. Ploussard G, Nicolaiew N, Marchand C, et al. Risk of repeat biopsy and prostate cancer detection after an initial extended negative biopsy: longitudinal follow-up from a prospective trial. BJU Int. 2013;111(6):988-996. |
Observational-Dx |
617 men |
To assess prospectively the time-varying risk of rebiopsy and of prostate cancer (PCa) detection after an initial negative biopsy protocol. |
A total of 617 men (31%) underwent at least one rebiopsy after a mean follow-up of 19 months. PCa detection rates during second, third, and fourth sets of biopsies were 16.7, 16.9 and 12.5%, respectively. The overall rate of detected PCa was 7.0%. The 5-year rebiopsy-free and PCa-free survival rates were 65.9 and 92.5%, respectively. Indications for rebiopsy were more frequently reported in patients having a high prostate-specific antigen (PSA) level (P = 0.006) or a high PSA density (PSAD; P < 0.001) and in younger patients (P = 0.008). The risk of PCa on rebiopsies was not correlated with age, but significantly increased more than twofold in cases of PSA >6 ng/mL, PSAD >0.15 ng/mL/g, free-to-total PSA ratio (%fPSA) <15, and/or prostate volume <50 mL. Time-dependent analyses were in line with these findings. The main study limitation was the lack of control of the absence of PCa and PSA kinetics in men not rebiopsied. |
3 |
| 75. Roehl KA, Antenor JA, Catalona WJ. Serial biopsy results in prostate cancer screening study. J Urol. 2002;167(6):2435-2439. |
Review/Other-Dx |
2,526 |
To evaluate prostate biopsy results in men with elevated prostate specific antigen (PSA) levels and/or suspicious digital rectal examination whose initial biopsies did not reveal cancer. |
Of the men who underwent up to 10 biopsy procedures the serial cancer detection rates were 29%, 17%, 14%, 11%, 9% and 7%, respectively, on biopsy procedures 1 through 6. No significant difference in the yield of cancer on serial biopsies was observed between the groups using the greater than 4.0 ng./ml. and greater than 2.5 ng./ml. cutoff. There was a trend for more cancers detected through serial screening to be organ confined compared with those detected on initial screening (78% versus 69%, p = 0.05). Also, more cancers detected using the greater than 2.5 ng./ml. cutoff were organ confined (80% versus 66%, p = 0.004). Only approximately 1% of the cancers fulfilled the published criteria for clinically insignificant tumors. |
4 |
| 76. Vencalek O, Facevicova K, Furst T, Grepl M. When less is more: a simple predictive model for repeated prostate biopsy outcomes. Cancer Epidemiol. 2013;37(6):864-869. |
Observational-Dx |
221 patients |
To present a new predictive model for repeated prostate biopsy outcomes. |
Of the 221 patients, 29 (13%) were diagnosed with prostate cancer on the repeated biopsy. The final model includes the PSA level and the transitory zone volume as predictors. Its accuracy is 76.4%. The cut-off point of 0.0687 in the predicted positive repeated biopsy outcome assures 95% sensitivity and prevents 42% of unnecessary biopsies. |
4 |
| 77. Zaytoun OM, Stephenson AJ, Fareed K, et al. When serial prostate biopsy is recommended: most cancers detected are clinically insignificant. BJU Int. 2012;110(7):987-992. |
Observational-Dx |
749 patients |
To investigate the total rate of cancer detection in serial biopsy and how many of these were deemed clinically insignificant. |
Prostate cancer was detected in 15.9% of 749 serial biopsies, representing a cumulative prostate cancer detection rate of 24.8% (119/479 patients). * The sPBx group had a significantly higher detection rate per biopsy session (18.6% vs 12.7%, P= 0.026). * Nevertheless, most positive biopsies 75/119 (63%) revealed clinically insignificant cancer, including 74.6% of cancers detected by sPBx. |
3 |
| 78. KandaSwamy GV, Bennett A, Narahari K, Hughes O, Rees J, Kynaston H. Establishing the pathways and indications for performing isotope bone scans in newly diagnosed intermediate-risk localised prostate cancer - results from a large contemporaneous cohort. BJU Int. 120(5B):E59-E63, 2017 11. |
Observational-Dx |
976 patients |
To establish the pattern of isotope bone scan (BS) positivity in a large contemporaneous cohort of patients with newly diagnosed localised prostate cancer and compare with the European Association of Urology (EAU) guidelines, as imaging guidelines and clinical practice for using BS to stage newly diagnosed patients with intermediate-risk localised prostate cancer are not uniform in the literature. |
Of 976 patients in the D'Amico intermediate-risk category, 99 had primary Gleason pattern 4. Only one of the 99 patients had a positive BS and there were no positive BS in patients with Gleason primary pattern 3 in the intermediate-risk category. On subgroup analysis, based on prostate-specific antigen (PSA) level and Gleason grade alone, the BS-positivity rate in patients with a PSA level of <20 ng/mL and Gleason primary pattern 4 vs 3 was 6% and 0%, respectively, resulting in 100% NPV for a positive BS with Gleason primary pattern 3 and a PSA level of <20 ng/mL. The importance of clinical T stage (cT) was also noted, as eight of 146 patients had positive BS, who were high risk on cT stage, with a PSA level of <20 ng/mL and Gleason score <8. All eight patients had Gleason primary pattern 4. By limiting BS to the population at risk (all high-risk + intermediate-risk with primary pattern 4), 68 BS per year could have been avoided in a single centre. A limitation was that there was no histological confirmation of bony metastases. Extending the BS recommendation considering the new Gleason Grade Grouping is discussed. |
3 |
| 79. Wondergem M, van der Zant FM, Knol RJJ, et al. 99mTc-HDP bone scintigraphy and 18F-sodiumfluoride PET/CT in primary staging of patients with prostate cancer. World J Urol. 36(1):27-34, 2018 Jan. |
Observational-Dx |
104 patients |
To evaluate the performance and clinical impact of both BS and NaF PET/CT in primary staging of patients with prostate cancer. |
One-hundred-and-four patients underwent NaF PET/CT, whereas 122 patients underwent BS. Sensitivities of 97-100 and 84-95% and specificities of 98-100 and 72-100% were found on a patient basis for detection of bone metastases with NaF PET/CT and BS, respectively. Equivocal findings warranted further diagnostic procedures in 2% of the patients in the NaF cohort and in 16% in the BS cohort. In addition NaF PET/CT demonstrated lymph node metastases in 50% of the included patients, of which 25% showed evidence of lymph node metastases only. |
2 |
| 80. Suh CH, Shinagare AB, Westenfield AM, Ramaiya NH, Van den Abbeele AD, Kim KW. Yield of bone scintigraphy for the detection of metastatic disease in treatment-naive prostate cancer: a systematic review and meta-analysis. [Review]. Clin Radiol. 73(2):158-167, 2018 02. |
Meta-analysis |
54 studies |
To evaluate the yield of staging bone scintigraphy in patients with treatment-naive prostate cancer. |
Fifty-four eligible studies, which included a total sample size of 20,421 patients, were included. The pooled proportions of the positive bone scintigraphy in patients with PSA =10, 10 <PSA =20, and PSA >20 were 3.5% (95% confidence interval [CI]: 2.4-5%), 6.9% (95% CI: 4.5-10.3%), and 41.8% (95% CI: 36.3-47.6%). The pooled proportions of the positive bone scintigraphy examinations in patients with Gleason score =6, 7, and =8 were 4.1% (95% CI: 2-8%), 10% (95% CI: 6.1-15.8%), and 28.7% (95% CI: 21.8-36.8%). Meta-regression analysis revealed that the Gleason score was a significant factor affecting study heterogeneity in patients with PSA =10 (p = 0.04). Pooled proportions of positive bone scintigraphy examinations showed 3.4% in patients with a PSA of =10 and 3.3% in patients with 10 <PSA =20 regarding a Gleason score of =7. |
Good |
| 81. Cantiello F, Russo GI, Kaufmann S, et al. Role of multiparametric magnetic resonance imaging for patients under active surveillance for prostate cancer: a systematic review with diagnostic meta-analysis. Prostate Cancer Prostatic Dis. 22(2):206-220, 2019 05. |
Meta-analysis |
226 studies |
To evaluate the accuracy of mpMRI to monitor re-classification or progression in patients under AS. |
In total, 226 studies were selected after research and after removal of duplicates. After analysis on inclusion criteria, 43 studies were identified as eligible for this systematic review with a total of 6,605 patients. The timing of MRI during follow-up of AS differed from all studies like criteria for inclusion in the AS protocol. Overall, there was a low risk of bias across all studies. The diagnostic meta-analysis for 1.5 tesla showed a sensitivity of 0.60, negative predictive value (NPV) of 0.75 and a hierarchical summary receiving operating curve (HSROC) of 0.74 while for 3.0 tesla mpMRI a sensitivity of 0.81, a NPV of 0.78 and a HSROC of 0.83. |
Inadequate |
| 82. Amin A, Scheltema MJ, Shnier R, et al. The Magnetic Resonance Imaging in Active Surveillance (MRIAS) Trial: Use of Baseline Multiparametric Magnetic Resonance Imaging and Saturation Biopsy to Reduce the Frequency of Surveillance Prostate Biopsies. J Urol. 203(5):910-917, 2020 05. |
Observational-Dx |
172 men |
To 1) assess the diagnostic utility of baseline and serial mpMRI to predict biopsy proven progression to csPCa in men on AS and 2) prospectively assess the oncologic safety of an AS protocol that replaces confirmatory biopsy at 1 year with selective biopsy triggered by suspicious mpMRI. |
We report the prespecified interim analysis of the first 100 men at 3 years. At baseline the median age was 64.5 (IQR 57.25-69) years, prostate specific antigen was 4.7 ng/ml (IQR 3.4-6.6), 91% had Gleason 3+3=6 prostate cancer and multiparametric magnetic resonance imaging was negative (Prostate Imaging Reporting and Data System 1/2/3) in 87% of men. Within 3 years 21% experienced pathological progression. The positive predictive value, negative predictive value, sensitivity and specificity for detection of clinically significant prostate cancer by surveillance multiparametric magnetic resonance imaging was 45%, 89%, 61% and 80%, respectively. Positive surveillance magnetic resonance imaging (p=0.002) and prostate specific antigen density greater than 0.2 ng/ml (p=0.042) had significant predictive value for clinically significant prostate cancer. |
3 |
| 83. Henderson DR, de Souza NM, Thomas K, et al. Nine-year Follow-up for a Study of Diffusion-weighted Magnetic Resonance Imaging in a Prospective Prostate Cancer Active Surveillance Cohort. Eur Urol. 69(6):1028-33, 2016 06. |
Observational-Dx |
86 patients |
To determine long-term outcomes with respect to the apparent diffusion coefficient (ADC) derived from diffusion-weighted magnetic resonance imaging (DW-MRI) in a prospective AS cohort. |
The median follow-up was 9.5 yr (interquartile range 7.9-10.0 yr). On univariate analysis, ADC below the median was associated with shorter TAH (hazard ratio [HR] 2.13, 95% confidence interval [CI] 1.17-3.89; p<0.014) and TRT (HR 2.54, 95% CI 1.49-4.32; p<0.001). Median TRT was 9.3 yr (95% CI 7.0-11.6 yr) for patients with ADC above the median and only 2.4 yr (95% CI 1.5-6.0 yr) for ADC below the median. For TRT, addition of ADC to a multivariate model of baseline variables resulted in a significant improvement in model fit (HR 1.33, 95% CI 1.14-1.54; p<0.001). Receiver operating characteristic analysis for TRT revealed an area under the curve of 0.80 (95% CI 0.70-0.88). |
2 |
| 84. Kornberg Z, Cowan JE, Westphalen AC, et al. Genomic Prostate Score, PI-RADS TM version 2 and Progression in Men with Prostate Cancer on Active Surveillance. J Urol. 201(2):300-307, 2019 02. |
Observational-Dx |
440 men |
To determine whether these tests (OncotypeDx GPS and PI-RADS) are associated with an increased risk of biopsy upgrading in men on active surveillance. |
Of the men 140 had only GPS test findings, 169 had only a PI-RADS version 2 score and 131 had both data. Each 5-unit increase in the GPS was associated with an increased risk of biopsy upgrading (HR 1.28, 95% CI 1.19-1.39, p <0.01). PI-RADS scores of 5 vs 1-2 (HR 4.38, 95% CI 2.36-8.16, p <0.01) and 4 vs 1-2 (HR 2.62, 95% CI 1.45-4.76, p <0.01) were also associated with an increased risk of a biopsy upgrade. On subanalysis of patients with GPS and PI-RADS version 2 scores the GPS was associated with biopsy upgrading, adding value to the clinical covariates (partial likelihood ratio p = 0.01). |
3 |
| 85. Bryant RJ, Yang B, Philippou Y, et al. Does the introduction of prostate multiparametric magnetic resonance imaging into the active surveillance protocol for localized prostate cancer improve patient re-classification?. BJU Int. 122(5):794-800, 2018 11. |
Observational-Dx |
445 patients |
To determine whether replacement of protocol-driven repeat prostate biopsy (PB) with multiparametric magnetic resonance imaging (mpMRI) ± repeat targeted prostate biopsy (TB) when evaluating men on active surveillance (AS) for low-volume, low- to intermediate-risk prostate cancer (PCa) altered the likelihood of or time to treatment, or reduced the number of repeat biopsies required to trigger treatment. |
Of 445 patients, 132 (30%) discontinued AS and underwent treatment intervention, with a median (IQR) time to treatment of 1.55 (0.71-2.4) years. The commonest trigger for treatment was PCa upgrading after mpMRI and TB (43/132 patients, 29%). No significant difference was observed in the time at which patients receiving a PB alone or receiving mpMRI ± TB discontinued AS to undergo treatment (median 1.9 vs 1.33 years; P = 0.747). Considering only those patients who underwent repeat biopsy, a greater proportion of patients receiving TB after mpMRI discontinued AS compared with those receiving PB alone (29/66 [44%] vs 32/87 [37%]; P = 0.003). On average, a single set of repeat biopsies was needed to trigger treatment regardless of whether this was a PB or TB. |
3 |
| 86. Bloom JB, Hale GR, Gold SA, et al. Predicting Gleason Group Progression for Men on Prostate Cancer Active Surveillance: Role of a Negative Confirmatory Magnetic Resonance Imaging-Ultrasound Fusion Biopsy. J Urol. 201(1):84-90, 2019 01. |
Observational-Dx |
542 patients |
To determine the implication of a negative FB, consisting of all targeted lesions and SB, for disease progression and the rate of AS discontinuation. |
Of the 542 patients referred with Grade Group 1 (466) or Grade Group 2 (76) cancer 111 (20.5%) had a negative fusion biopsy. A total of 60 vs 122 patients with a negative vs a positive fusion biopsy were followed on active surveillance with a median time to Grade Group progression of 74.3 and 44.6 months, respectively (p <0.01). Negative fusion biopsy was associated with a reduced risk of Grade Group progression (HR 0.41, 95% CI 0.22-0.77, p <0.01). |
3 |
| 87. Arabi A, Deebajah M, Yaguchi G, et al. Systematic Biopsy Does Not Contribute to Disease Upgrading in Patients Undergoing Targeted Biopsy for PI-RADS 5 Lesions Identified on Magnetic Resonance Imaging in the Course of Active Surveillance for Prostate Cancer. Urology. 134:168-172, 2019 Dec. |
Observational-Dx |
148 patients |
To compare the utility of the systematic 12-core prostate biopsy (SB) combined with magnetic resonance imaging (MRI)-targeted lesion biopsy (MRI-TB) vs MRI-TB alone in the diagnosis of high PI-RADS lesions. |
Of the 255 total lesions (247 lesions with PI-RADS =3), 141 were upgraded from the previous biopsy (55.3%). Of these, 104 were upgraded by the MRI-TB (40.8%), and 87 lesions were upgraded by the SB (34.1%). The MRI-TB had a NU rate of 26.2% for all lesions. On subanalysis, the NU rates of PI-RADS 3, 4, and 5 MRI-TBs were 39.3%, 21.2%, and 3.4%, respectively. |
3 |
| 88. Borkowetz A, Renner T, Platzek I, et al. Evaluation of Magnetic Resonance Imaging/Ultrasound-Fusion Biopsy in Patients with Low-Risk Prostate Cancer Under Active Surveillance Undergoing Surveillance Biopsy. Urol Int. 100(2):155-163, 2018. |
Observational-Dx |
83 patients |
To compare MRI/ultrasound-fusion biopsy (fusPbx) with systematic biopsy (sysPbx) in patients undergoing biopsy for A |
Eighty-three patients were enrolled. PCa upgrading was detected in 39% by fusPbx and in 37% by sysPbx (p = 1.0). The percentage of patients who were reclassified in fusPbx and sysPbx (p = 0.45) were 64 and 59% respectively. ComPbx detected more frequently tumour upgrading than fusPbx (71 vs. 64%, p = 0.016) and sysPbx (71 vs. 59%, p < 0.001) and more patients had to be reclassified after comPbx than after fusPbx or sysPbx alone. |
3 |
| 89. Klotz L, Loblaw A, Sugar L, et al. Active Surveillance Magnetic Resonance Imaging Study (ASIST): Results of a Randomized Multicenter Prospective Trial. Eur Urol. 75(2):300-309, 2019 02. |
Observational-Dx |
273 men |
To determine, in men recently diagnosed with grade group 1 (GG1) prostate cancer, if magnetic resonance imaging (MRI) with targeted biopsy could identify a greater proportion of men with GG =2 cancer on their confirmatory biopsy compared with systematic biopsies. |
In total, 296 men were registered and 273 randomized. Of the MRI group, 64% had a region of interest. No difference was observed in the rate of GG =2 upgrading (the intent-to-treat population, p=0.7, and per-protocol [PP] population, p=0.4), GG =2 upgrading within each stratum separately, or GG =3. After central pathology review, upgrading was observed in 36/132 (27%) men in the systematic biopsy arm and 42/127 (33%) men in the MRI arm (p=0.3). Upgrading was seen in 19/137 (14%) patients in the MRI arm on targeted biopsy alone (median, 2 cores) compared with 31/136 (23%) in the systematic biopsy arm (median, 12 cores; p=0.09). In the MRI arm, 8/127 (6.5%) patients had GG =2 disease identified on targeted biopsy, but =GG1 on the systematic biopsy, and 10/127 (7.9%) patients had GG =2 disease identified by systematic biopsy but =GG1 on targeted biopsy. Significant differences in upgrading on targeted biopsies were seen between sites, likely reflecting different levels of expertise with the targeted biopsy technique. |
3 |
| 90. Ma TM, Tosoian JJ, Schaeffer EM, et al. The Role of Multiparametric Magnetic Resonance Imaging/Ultrasound Fusion Biopsy in Active Surveillance. Eur Urol. 71(2):174-180, 2017 02. |
Observational-Dx |
230 men |
To assess TB in active surveillance (AS). |
GS =7was detected by either biopsy method in 25 men (24.3%) in the AS group, 12 men (22.2%) in the CB group, and 55 men (75.3%) in the DB group.GS =7 was found in 24.3% by SB + TB versus 20.4% by SB in the AS group (p=0.13); in 22.2% by SB + TB versus 16.7% by SB in the CB group (p=0.25); and in 75.3% by SB + TB versus 58.9% by SB in the DB group (p=0.002). The sensitivity for GS =7 detection was lower for TB than for SB (p=0.006) in the AS cohort (relative sensitivity ratio 0.33, 95% confidence interval 0.16-0.71). Higher PI-RADS score (4 vs 3, odds ratio [OR] 2.00, p=0.04; 5 vs 3, OR 4.74, p=0.02), lower MRI-estimated prostate volume (OR 1.20 per 10-cm3 lower volume, p=0.01), larger ROI (OR 1.04 per mm, p=0.02), and right-sided ROI (OR 2.27, p=0.01) were associated with finding cancer on TB. A potential limitation is that not all men who presented for biopsy underwent TB and the urologist was not blinded to MRI results before SB. |
3 |
| 91. Pepe P, Garufi A, Priolo G, Pennisi M. Can MRI/TRUS fusion targeted biopsy replace saturation prostate biopsy in the re-evaluation of men in active surveillance?. World J Urol. 34(9):1249-53, 2016 Sep. |
Observational-Dx |
40 men |
To evaluate the detection rate for significant prostate cancer of mMRI/TRUS fusion targeted biopsy versus saturation prostate biopsy in men enrolled in active surveillance (AS) protocol. |
Ten out of 40 (25 %) patients were reclassified by SPBx based on upgraded GS = 7; mpMRI found all the lesions predictive of significant PCa showing a false-positive rate equal to 5 %; on the contrary, mpMRI/TRUS targeted biopsy missed 3/10 (30 %) significant PCa characterised by the presence of a single positive core of GS = 7 and GPC = 5 %, suggesting that reduced number of targeted biopsies could miss small but significant PCa. Diagnostic accuracy, sensitivity, specificity, and positive and negative predictive value of mpMRI in diagnosing significant PCa were 95.2, 100, 93.8, 83.4, 100 %, respectively. |
1 |
| 92. Recabal P, Assel M, Sjoberg DD, et al. The Efficacy of Multiparametric Magnetic Resonance Imaging and Magnetic Resonance Imaging Targeted Biopsy in Risk Classification for Patients with Prostate Cancer on Active Surveillance. J Urol. 196(2):374-81, 2016 Aug. |
Observational-Dx |
206 men |
To evaluate the efficacy of prostate MRI-targeted biopsy to detect higher grade cancer (defined here as Gleason score=3+4) and also describe the efficacy to rule out higher grade disease in patients on AS for Gleason 3+3 prostate cancer. In addition, we sought to assess whether MRI-targeted biopsies may be used instead of systematic biopsy or whether a biopsy might be avoided based on the level of suspicion of detecting cancer on imaging depicted by MRI score. |
Of 206 consecutive men on active surveillance 135 (66%) had a multiparametric magnetic resonance imaging region of interest. Overall, higher grade cancer was detected in 72 (35%) men. A higher multiparametric magnetic resonance imaging score was associated with an increased probability of detecting higher grade cancer (Wilcoxon-type trend test p <0.0001). Magnetic resonance imaging targeted biopsy detected higher grade cancer in 23% of men. Magnetic resonance imaging targeted biopsy alone missed higher grade cancers in 17%, 12% and 10% of patients with multiparametric magnetic resonance imaging scores of 3, 4 and 5, respectively. |
3 |
| 93. Jung AJ, Coakley FV, Shinohara K, et al. Local staging of prostate cancer: comparative accuracy of T2-weighted endorectal MR imaging and transrectal ultrasound. Clin Imaging. 2012;36(5):547-552. |
Observational-Dx |
101 patients |
To compare the accuracy of T2-weighted magnetic resonance (MR) imaging and transrectal ultrasound (TRUS) for staging of prostate cancer. |
Staging accuracy was not significantly different between MR imaging (A(z) = 0.69-0.70) and TRUS (A(z) = 0.81, P>.05). |
2 |
| 94. Eltemamy MM, Leapman MS, Cowan JE, Westphalen A, Shinohara K, Carroll PR. Serial Anatomical Prostate Ultrasound during Prostate Cancer Active Surveillance. J Urol. 196(3):727-33, 2016 Sep. |
Review/Other-Dx |
875 patients |
To evaluate the incidence, growth dynamics and clinical significance of changes in prostate lesions on serial transrectal ultrasound among a large cohort of men with prostate cancer managed by active surveillance. |
The 875 identified patients underwent a median of 5 transrectal ultrasound studies (IQR 3-8). Median followup was 49 months (IQR 27-81). Of the patients 345 (39%) progressed on serial transrectal ultrasound, including 51 by size, 265 by the number of lesion sites and 279 by stage. Median time to progression was 14 months. Transrectal ultrasound progression was independently associated with biopsy upgrade (OR 1.8, 95% CI 1.3-2.5, p <0.01). |
4 |
| 95. Zhou J, Gou Z, Wu R, Yuan Y, Yu G, Zhao Y. Comparison of PSMA-PET/CT, choline-PET/CT, NaF-PET/CT, MRI, and bone scintigraphy in the diagnosis of bone metastases in patients with prostate cancer: a systematic review and meta-analysis. Skeletal Radiol. 48(12):1915-1924, 2019 Dec. |
Meta-analysis |
1700 |
To compare the diagnostic performance of prostate-specific membrane antigen (PSMA)-PET/CT, choline-PET/CT, Sodium Fluoride (NaF) PET/CT, MRI, and bone scintigraphy (BS) in detecting bone metastases in patients with prostate cancer. |
The per-patient pooled sensitivities of PSMA-PET/CT, choline-PET/CT, NaF-PET/CT, MRI, and BS were 0.97, 0.87, 0.96, 0.91, and 0.86, respectively. The pooled specificities were 1.00, 0.99, 0.97, 0.96, and 0.95, respectively. The pooled DOR values were 504.16, 673.67, 242.63, and 114.44, respectively. The AUC were 1.00, 0.99, 0.99, 0.98, and 0.95, respectively. The per-lesion pooled sensitivities of PSMA-PET/CT, choline-PET/CT, NaF-PET/CT, MRI, and bone imaging were 0.88, 0.80, 0.97, 0.81 and 0.68, respectively. |
Good |
| 96. Johnston EW, Latifoltojar A, Sidhu HS, et al. Multiparametric whole-body 3.0-T MRI in newly diagnosed intermediate- and high-risk prostate cancer: diagnostic accuracy and interobserver agreement for nodal and metastatic staging. Eur Radiol. 29(6):3159-3169, 2019 Jun. |
Observational-Dx |
56 men |
To determine the diagnostic accuracy and interobserver concordance of whole-body (WB)-MRI, vs. 99mTc bone scintigraphy (BS) and 18fluoro-ethyl-choline (18F-choline) PET/CT for the primary staging of intermediate/high-risk prostate cancer. |
The mean sensitivity/specificity of WB-MRI for N1 disease was 1.00/0.96 respectively, compared with 1.00/0.82 for 18F-choline PET/CT. The mean sensitivity and specificity of WB-MRI, 18F-choline PET/CT, and BS were 0.90/0.88, 0.80/0.92, and 0.60/1.00 for M1b disease. ROC-AUC did not show statistically significant improvement for each component of the LSR; mean ROC-AUC 0.92, 0.94, and 0.93 (p < 0.05) for mDixon + DWI, + T2WI, and + contrast respectively. WB-MRI had an interobserver concordance (?) of 0.79, 0.68, and 0.58 for N1, M1a, and M1b diseases respectively. |
2 |
| 97. Haran C, McBean R, Parsons R, Wong D. Five-year trends of bone scan and prostate-specific membrane antigen positron emission tomography utilization in prostate cancer: A retrospective review in a private centre. J Med Imaging Radiat Oncol. 63(4):495-499, 2019 Aug. |
Review/Other-Dx |
3144 exams |
To describe the trends of use between Gallium-68 prostate-specific membrane antigen ligand (Ga-68 PSMA) PET/computed tomography (PSMA PET/CT) and nuclear medicine bone scan (NMBS) for prostate cancer staging in the first institution in Australia to offer both modalities. |
A total of 3144 examinations were performed in the time period reviewed, with 546 NMBS and 2598 PSMA PET/CT scans performed. In the 6 months after PSMA PET/CT was introduced, there was a 45.7% decrease in the number of NMBS performed and 95.3% decrease across the duration of the study. In the PSMA PET/CT cohort, 1569 examinations were performed for pre-treatment staging and 1029 performed for secondary staging. There was a significant difference in the proportion of PSMA PET/CT conducted for pre-treatment staging compared with secondary staging when comparing the first and final 500 examinations (P < 0.05). |
4 |
| 98. Kim SJ, Lee SW. The role of 18F-fluciclovine PET in the management of prostate cancer: a systematic review and meta-analysis. Clin Radiol. 74(11):886-892, 2019 Nov. |
Meta-analysis |
13 studies |
To investigate the diagnostic performance of 18F-fluciclovine positron-emission tomography (PET) or combined PET and computed tomography (PET/CT) for diagnosis of primary cancer, preoperative lymph node (LN) staging, and detection of recurrent disease of prostate cancer (PCa) through a systematic review and meta-analysis. |
Across 13 studies (563 patients), the pooled sensitivity for 18F-fluciclovine PET or PET/CT for diagnosis of primary PCa was 0.87 (95% confidence interval [CI]: 0.77-0.93) and a pooled specificity of 0.84 (95% CI: 0.68-0.93). For LN staging, the pooled sensitivity was 0.56 (95% CI: 0.37-0.74) and a pooled specificity of 0.98 (95% CI: 0.88-1.00). For detection of recurrent disease, the pooled sensitivity was 0.79 (95% CI: 0.60-0.91) and a pooled specificity of 0.69 (95% CI: 0.59-0.77). In meta-regression analysis, no definite variable was the source of the study heterogeneity. |
Good |
| 99. Evangelista L, Cimitan M, Zattoni F, Guttilla A, Zattoni F, Saladini G. Comparison between conventional imaging (abdominal-pelvic computed tomography and bone scan) and [(18)F]choline positron emission tomography/computed tomography imaging for the initial staging of patients with intermediate- tohigh-risk prostate cancer: A retrospective analysis. Scand J Urol. 49(5):345-53, 2015. |
Observational-Dx |
48 patients |
To evaluate the efficiency of [18F]fluorocholine positron emission tomography/computed tomography (FCH PET/CT) in detecting lymph-node and bone involvement in comparison with conventional imaging, such as abdominal–pelvic CT and bone scan, in the initial staging of prostate cancer (PCa) |
The overall accuracy of FCH PET/CT for lymph-node involvement was 83.3%. The sensitivity of FCH was higher in the high-risk subset (83.3%) than in the intermediate-risk group (33.3%), whereas FCH specificity was similar. In comparison with dedicated CT scan, FCH PET/CT showed a higher sensitivity and a similar specificity (46.2% vs 69.2% and 92.3% vs 92.3%, respectively). Moreover, the sensitivity and specificity of PET/CT were higher than those of bone scan (100% vs 90% and 86.4% vs 77.2%, respectively). In contrast with conventional imaging, PET/CT changed the staging of the PCa in 33.3% patients |
3 |
| 100. Samper Ots P, Luis Cardo A, Vallejo Ocana C, et al. Diagnostic performance of 18F-choline PET-CT in prostate cancer. Clin Transl Oncol. 21(6):766-773, 2019 Jun. |
Observational-Dx |
269 patients |
To evaluate the diagnostic performance of 18F-choline PETCT in staging prostate cancer (PC) and whether the use of this imaging modality changes the therapeutic decision in patients previously staged by conventional imaging. The secondary aim was to determine the prognostic factors associated with positive choline PETCT findings in both detection of disseminated disease and in changes in the therapeutic indication. |
The mean PSA by groups was, group 1: 31.22 ng/ml, group 2: 2.52 ng/ml and group 3: 5.85 ng/ml. The tumor detection rate with 18F-choline PETCT was 74% (group 1: 85.5%, group 2: 55.1% and group 3: 91%). Prognostic factors for positive 18F-choline PETCT were identified only in group 2: PSA at failure and PSADT. 18F-choline PETCT changed the therapeutic indication in 62.8% (group 1: 71%, group 2: 55.2% and group 3: 70.1%). The prognostic factors for a change in treatment were identified only in group 1: secondary Gleason = 4 and GS = 7 and in group 2: PSA at failure, PSA nadir after surgery and pathologic stage N0. 18F-choline PETCT identified lymph node and/or metastatic disease in 32.7% (group 1: 25.8%, group 2: 29.7% and group 3: 41.6%). Prognostic factors for detecting lymph node/metastasis were identified in the group 2: PSA failure = 1.37 ng/ml and PSADT < 4 months and in the group 3: PSADT < 4.6 months and time to failure < 5 years. |
3 |
| 101. Metser U, Berlin A, Halankar J, et al. 18F-Fluorocholine PET Whole-Body MRI in the Staging of High-Risk Prostate Cancer. AJR Am J Roentgenol. 210(3):635-640, 2018 Mar. |
Observational-Dx |
58 patients |
To determine whether integrated 18F-fluorocholine (FCH) PET whole-body MRI (PET/WBMRI) depicts lymph node and distant metastases in patients with high-risk prostate cancer more frequently than does conventional staging. |
In the detection of metastases, PET had significantly higher sensitivity (72/77 [93.5%]) than conventional imaging (49/77 [63.6%]; p < 0.001) and WBMRI (56/77 [72.7%]; p = 0.002). There was a trend toward improved detection with PET/WBMRI (77/77 [100%]) compared with PET alone (p = 0.059). For correct NM staging, PET and PET/WBMRI performed better than conventional imaging (p = 0.002) and WBMRI (p = 0.008). Twelve of 56 patients (21.4%) had early biochemical failure after radical treatment (median, 7 months; range, 1-20 months). This rate was higher for patients with M1a or M1b disease at PET/WBMRI than for others, but this finding did not reach statistical significance (4/8 [50%] vs 8/48 [16.7%]; p = 0.055). |
2 |
| 102. Jambor I, Kuisma A, Kahkonen E, et al. Prospective evaluation of 18F-FACBC PET/CT and PET/MRI versus multiparametric MRI in intermediate- to high-risk prostate cancer patients (FLUCIPRO trial). Eur J Nucl Med Mol Imaging. 45(3):355-364, 2018 03. |
Observational-Dx |
26 ment |
To evaluate 18F-FACBC PET/CT, PET/MRI, and multiparametric MRI (mpMRI) in detection of primary prostate cancer (PCa). |
In the visual analysis, 164/312 (53%) regions contained PCa, and 41 tumor foci were identified. PET/CT demonstrated the highest sensitivity at 87% while its specificity was low at 56%. The AUC of both PET/MRI and mpMRI significantly (p < 0.01) outperformed that of PET/CT while no differences were detected between PET/MRI and mpMRI. SUVmax and VT of Gleason score (GS) >3 + 4 tumors were significantly (p < 0.05) higher than those for GS 3 + 3 and benign hyperplasia. A total of 442 lymph nodes were evaluable for staging, and PET/CT and PET/MRI demonstrated true-positive findings in only 1/7 patients with metastatic lymph nodes. |
2 |
| 103. Elschot M, Selnaes KM, Sandsmark E, et al. Combined 18F-Fluciclovine PET/MRI Shows Potential for Detection and Characterization of High-Risk Prostate Cancer. J Nucl Med. 59(5):762-768, 2018 05. |
Observational-Dx |
28 patients |
To investigate whether quantitative imaging features derived from combined 18F-fluciclovine PET/multiparametric MRI show potential for detection and characterization of primary prostate cancer. |
Voxel and VOI features were extracted from 40 tumor VOIs (26 high-grade), 36 BPH VOIs, 6 prostatitis VOIs, and 37 healthy-tissue VOIs. PET/MRI performed better than MRI and PET alone for distinguishing tumors from benign tissue (AUCs of 87%, 81%, and 83%, respectively, at the voxel level and 96%, 93%, and 93%, respectively, at the VOI level) and high-grade tumors from other tissue (AUCs of 85%, 79%, and 81%, respectively, at the voxel level and 93%, 93%, and 91%, respectively, at the VOI level). T2-weighted MRI, diffusion-weighted MRI, and PET features were the most important for classification. |
3 |
| 104. Elschot M, Selnaes KM, Sandsmark E, et al. A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. Eur J Nucl Med Mol Imaging. 44(4):695-703, 2017 Apr. |
Observational-Dx |
28 patients |
To optimise the PET imaging protocol for detection and characterisation of primary prostate cancer, by quantitative evaluation of the dynamic uptake of [18F]Fluciclovine in cancerous and benign tissue. |
Twenty-eight (28) patients [median (range) age: 66 (55-72) years] were included. An early (W1: 5-10 minutes post-injection) and two late candidate windows (W2: 18-23; W3: 33-38 minutes post-injection) were selected. Late compared with early imaging was better able to distinguish between malignant and benign tissue [W3, SUVmean: tumour vs. BPH 2.5 vs. 2.0 (p<0.001), tumour vs. inflammation 2.5 vs. 1.7 (p<0.001), tumour vs. healthy tissue 2.5 vs. 2.0 (p<0.001); W1, SUVmean: tumour vs. BPH 3.1 vs. 3.1 (p=0.771), tumour vs inflammation 3.1 vs. 2.2 (p=0.021), tumour vs. healthy tissue 3.1 vs. 2.5 (p<0.001)] as well as between high-grade and low/intermediate-grade tumours (W3, SUVmean: 2.6 vs. 2.1 (p=0.040); W1, SUVmean: 3.1 vs. 2.8 (p=0.173)). These differences were relevant to the peripheral zone, but not the central gland. |
2 |
| 105. Selnaes KM, Kruger-Stokke B, Elschot M, et al. 18F-Fluciclovine PET/MRI for preoperative lymph node staging in high-risk prostate cancer patients. Eur Radiol. 28(8):3151-3159, 2018 Aug. |
Observational-Dx |
28 patients |
To investigate the diagnostic potential of simultaneous 18F-fluciclovine PET/MRI for pelvic lymph node (LN) staging in patients with high-risk prostate cancer. |
Patient- and region-based sensitivity/specificity for detection of pelvic LN metastases was 40 %/87.5 % and 35 %/95.7 %, respectively, for MRI and 40 %/100 % and 30 %/100 %, respectively, for PET. LN metastases in true-positive regions were significantly larger than metastases in false-negative regions. PET-positive stage N1 patients had higher metastatic burden than PET-negative N1 patients. |
2 |
| 106. Alemozaffar M, Akintayo AA, Abiodun-Ojo OA, et al. [18F]Fluciclovine Positron Emission Tomography/Computerized Tomography for Preoperative Staging in Patients with Intermediate to High Risk Primary Prostate Cancer. J Urol. 204(4):734-740, 2020 10. |
Observational-Dx |
57 patients |
To determine if [18F]fluciclovine positron emission tomography/computerized tomography is an early indicator of subclinical metastasis among patients with high risk prostate cancer. |
Overall 57 of 68 patients completed the protocol, of whom 31 had nodal metastasis on histology. [18F]Fluciclovine positron emission tomography/computerized tomography sensitivity and specificity in detecting nodal metastasis was 55.3% and 84.8% per patient, and 54.8% and 96.4% per region (right and left pelvis, presacral and nonregional), respectively. Compared with conventional imaging [18F]Fluciclovine positron emission tomography/computerized tomography had significantly higher sensitivity on patient based (55.3% vs 33.3%, p <0.01) and region based (54.8% vs 19.4%, p <0.01) analysis, detecting metastasis in 7 more patients and 22 more regions, with similar high specificity. Four additional patients had distant disease or other cancer detected on [18F] fluciclovine positron emission tomography/computerized tomography which precluded surgery. |
2 |
| 107. Sheikhbahaei S, Jones KM, Werner RA, et al. 18F-NaF-PET/CT for the detection of bone metastasis in prostate cancer: a meta-analysis of diagnostic accuracy studies. Ann Nucl Med. 33(5):351-361, 2019 May. |
Meta-analysis |
507 patients |
To establish the diagnostic performance of 18F-NaF-PET/CT for the detection of bone metastases in prostate cancer patients. |
The pooled sensitivity, specificity, diagnostic odds ratio (DOR) and the area under the summary receiver operating characteristics curve (AUC) of 18F-NaF-PET/CT for the detection of bone metastases were 0.98 (95% CI 0.95-0.99), 0.90 (95% CI 0.86-0.93), 123.2 and 0.97, respectively. Seven studies provided the lesion-based accuracy information of 1812 lesions identified on 18F-NaF-PET/CT with the pooled sensitivity, specificity, DOR and AUC of 0.97 (95% CI 0.95-0.98), 0.84 (95% CI 0.81-0.87), 206.8 and 0.97, respectively. The overall diagnostic performance of 18F-NaF-PET/CT is superior to 99mTc-bone scintigraphy (AUC 0.842; P < 0.001; four studies) and 99mTc-SPECT (AUC 0.896; P < 0.001, four studies). Compared to 18F NaF-PET/CT, whole-body MRI with diffusion-weighted imaging (DWI) was shown to have lower sensitivity (0.83, 95% CI 0.68-0.93), with no significant difference in the overall performance (AUC 0.947; P = 0.18, four studies). |
Good |
| 108. Gauthe M, Aveline C, Lecouvet F, et al. Impact of sodium 18F-fluoride PET/CT, 18F-fluorocholine PET/CT and whole-body diffusion-weighted MRI on the management of patients with prostate cancer suspicious for metastasis: a prospective multicentre study. World J Urol. 37(8):1587-1595, 2019 Aug. |
Observational-Dx |
101 patients |
To compare the impact of 18F-sodium-fluoride (NaF) PET/CT, 18F-fluorocholine (FCH) PET/CT and diffusion-weighted whole-body MRI (DW-MRI) on the management of patients with prostate cancer (PCa) suspicious for distant metastasis. |
One-hundred-one patients (27 at staging, 59 at first biochemical recurrence (BCR) and 15 at first episode of rising serum level of prostate-specific antigen during androgen-deprivation therapy) were included. The overall rate of management changes was 52%: 29% as a consequence of WBI, higher for FCH-PET/CT than for NaF-PET/CT or DW-MRI (p < 0.0001) and highest (41%) for FCH-PET/CT at BCR. Actual management was adequate in all patients but two. |
3 |
| 109. Cooperberg MR, Cowan JE, Hilton JF, et al. Outcomes of active surveillance for men with intermediate-risk prostate cancer. J Clin Oncol. 2011;29(2):228-234. |
Review/Other-Dx |
540 men |
To determine the extent to which low- and intermediate-risk men differ in terms of risk factors for progression, and whether the rate of cancer progression is in fact higher among the men at intermediate risk. |
Compared to men with low-risk tumors, those with intermediate-risk tumors were older (mean, 64.9 v 62.3 years) with higher mean PSA values (10.9 v 5.1 ng/mL), and more tumor involvement (mean, 20.4% v 15.3% positive biopsy cores; all P < .01). Within 4 years of the first positive biopsy, the clinical risk group did not differ in terms of the proportions experiencing progression-free survival, (low [54%] v intermediate [61%]; log-rank P = .22) or the proportions who underwent active treatment (low [30%] v intermediate [35%]; log-rank P = .88). Among men undergoing surgery, none were node positive and none had biochemical recurrence within 3 years. |
4 |
| 110. Raldow AC, Zhang D, Chen MH, Braccioforte MH, Moran BJ, D'Amico AV. Risk Group and Death From Prostate Cancer: Implications for Active Surveillance in Men With Favorable Intermediate-Risk Prostate Cancer. JAMA Oncol. 2015;1(3):334-340. |
Observational-Dx |
5,580 patients |
To estimate and compare the risk of PC-specific mortality (PCSM) and all-cause mortality (ACM) following brachytherapy among men with low and favorable intermediate-risk PC. |
After median follow-up of 7.69 years, 605 men had died (10.84% of total cohort), 34 of PC (5.62% of total deaths). Men with favorable intermediate-risk PC did not have significantly increased risk of PCSM and ACM compared with men with low-risk PC (adjusted hazard ratio [HR], 1.64; 95% CI, 0.76-3.53; P = .21 for PCSM; adjusted HR, 1.11; 95% CI, 0.88-1.39; P = .38 for ACM). Eight-year adjusted point estimates for PCSM were low: 0.48% (95% CI, 0.23%-0.93%) and 0.33% (95% CI, 0.19%-0.56%) for men with favorable intermediate-risk PC and low-risk PC, respectively. The respective estimates for ACM were 10.45% (95% CI, 8.91%-12.12%) and 8.68% (95% CI, 7.80%-9.61%). |
3 |
| 111. Carlsson S, Benfante N, Alvim R, et al. Risk of Metastasis in Men with Grade Group 2 Prostate Cancer Managed with Active Surveillance at a Tertiary Cancer Center. J Urol. 203(6):1117-1121, 2020 06. |
Review/Other-Dx |
219 men |
To study the risk of metastatic prostate cancer development in men with Grade Group 2 disease managed with active surveillance at Memorial Sloan Kettering Cancer Center. |
Median age at diagnosis was 67 years (IQR 61-72), median prostate specific antigen was 5 ng/ml (IQR 4-7) and most patients (69%) had nonpalpable disease. During followup 64 men received treatment, including radical prostatectomy in 36 (56%), radiotherapy in 20 (31%), hormone therapy in 3 (5%) and focal therapy in 5 (8%). Of the 36 patients who underwent radical prostatectomy 32 (89%) had Grade Group 2 disease on pathology and 4 (11%) had Grade Group 3 disease. Treatment-free survival was 61% (95% CI 52-70) at 5 years and 49% (95% CI 37-60) at 10 years. Three men experienced biochemical recurrence, no men had distant metastasis and no men died of prostate cancer during the followup. Median followup was 3.1 years (IQR 1.9-4.9). |
4 |
| 112. Beksac AT, Sobotka S, Xu P, et al. Downgrading of Grade Group After Radical Prostatectomy: Comparison of Multiparametric Magnetic Resonance Imaging Guided Fusion Biopsy and Standard 12-Core Biopsy. Urology. 127:80-85, 2019 05. |
Observational-Dx |
536 patients |
To analyze the factors associated with Grade group (GG) downgrading post-radical prostatectomy. |
Ninety-three patients underwent fusion biopsy (FB) and 443 underwent the standard 12 core biopsy. Baseline clinical characteristics were similar between the 2 groups except for race (P = .009). Downgrading was observed in 76 patients (14.1%). Rate of downgrading was higher in the FB group (n = 22, 23.7% vs n = 54, 12.2%, P = .008). In multivariable logistic regression analysis, FB (OR:2.39, P = .004) and maximum percentage of core involvement (OR:1.01, P = .013) were associated with downgrading after robot-assisted laparoscopic radical prostatectomy. After 1:2 propensity score matching, FB was still associated with an increased rate of downgrading (P = .034). Downgrading had no significant effect on pathologic outcome. |
3 |
| 113. Woo S, Kim SY, Kim SH, Cho JY. JOURNAL CLUB: Identification of Bone Metastasis With Routine Prostate MRI: A Study of Patients With Newly Diagnosed Prostate Cancer. AJR Am J Roentgenol. 206(6):1156-63, 2016 Jun. |
Observational-Dx |
308 patients |
To evaluate whether routine prostate MRI is adequate for detection of bone metastasis in patients with newly diagnosed prostate cancer. |
Twenty-one (6.8%) patients had bone metastasis. They had significantly higher prostate-specific antigen levels (p = 0.015) and Gleason scores (p < 0.001) than those without bone metastasis. The diagnostic performance of MRI was as follows: sensitivity, 95.2%; specificity, 99–100%; positive predictive value, 86.9–100%; negative predictive value, 99.7%. For 119 patients at high risk of bone metastasis, these values were 95%, 100%, 100%, and 99%. Only 1 of the 21 (4.8%) patients had bone metastasis only in an area not explored with prostate MRI, that is, the thoracic spine. |
3 |
| 114. Hricak H, Wang L, Wei DC, et al. The role of preoperative endorectal magnetic resonance imaging in the decision regarding whether to preserve or resect neurovascular bundles during radical retropubic prostatectomy. Cancer. 2004; 100(12):2655-2663. |
Observational-Dx |
135 patients |
To evaluate endorectal MRI in the decision regarding whether to preserve or resect NVBs during radical RRP. |
MRI findings suggested altering the surgical plan in 39% of NVB (106/270 NVB). When the surgeon judged that the NVB resection was definitely not necessary (165 NVB), MRI confirmed that decision in 138 NVB (84%). The concordant decision was correct in 96% of the cases (133/138 NVB). In 36 high-risk patients (=75% probability of ECE), MRI findings changed the surgical plan for 28 NVB (78%); the change was found to be appropriate in 26 cases (93%). MRI was found to significantly improve the surgeon’s decision to preserve or resect the NVBs during RP. |
3 |
| 115. Muglia VF, Westphalen AC, Wang ZJ, Kurhanewicz J, Carroll PR, Coakley FV. Endorectal MRI of prostate cancer: incremental prognostic importance of gross locally advanced disease. AJR Am J Roentgenol. 2011;197(6):1369-1374. |
Observational-Dx |
66 patients with gross locally advanced disease and 65 controls. |
The purpose of this study was to determine the frequency and incremental prognostic importance of gross locally advanced disease seen at endorectal MRI in patients with prostate cancer. |
Sixty-six of 1777 (3.7%) patients had gross locally advanced disease. One of 1085 (0.1%) patients had low-risk disease, 25 of 489 (5.1%) had intermediate-risk disease, and 40 of 203 (19.7%) had high-risk disease. Follow-up data were available for 44 of these 66 patients. During a median follow-up period of 79 months, biochemical failure and metastasis had developed in 17 and 6 of these 44 patients compared with 9 and none of the 65 patients in the control group (p < 0.001). |
3 |
| 116. Robertson NL, Sala E, Benz M, et al. Combined Whole Body and Multiparametric Prostate Magnetic Resonance Imaging as a 1-Step Approach to the Simultaneous Assessment of Local Recurrence and Metastatic Disease after Radical Prostatectomy. J Urol. 198(1):65-70, 2017 07. |
Observational-Dx |
76 patients |
To report our initial experience with whole body and dedicated prostate magnetic resonance imaging as a single examination to assess local recurrence and metastatic disease in patients with suspected recurrent prostate cancer after radical prostatectomy. |
Median prostate specific antigen was 0.36 ng/ml (range less than 0.05 to 56.12). Whole body and dedicated prostate magnetic resonance imaging identified suspected disease recurrence in 16 of 76 patients (21%), including local recurrence in the radical prostatectomy bed in 6, nodal metastases in 3, osseous metastases in 4 and multifocal metastatic disease in 3. In 43 patients at least 1 standard staging scan was done in addition to whole body and dedicated prostate magnetic resonance imaging. Concordance was demonstrated between the imaging modalities in 36 of 43 cases (84%). All metastatic lesions detected by other imaging tests were detected on magnetic resonance imaging. In addition, the magnetic resonance imaging modality detected osseous metastases in 4 patients with false-negative findings on other imaging tests, including 2 bone scans and 3 computerized tomography scans. It also excluded osseous disease in 1 patient with positive 18F-fluorodeoxyglucose positron emission tomography/computerized tomography and subsequent negative bone biopsy. |
3 |
| 117. Tulsyan S, Das CJ, Tripathi M, Seth A, Kumar R, Bal C. Comparison of 68Ga-PSMA PET/CT and multiparametric MRI for staging of high-risk prostate cancer68Ga-PSMA PET and MRI in prostate cancer. Nucl Med Commun. 38(12):1094-1102, 2017 Dec. |
Observational-Dx |
36 patients |
To compare Glu-NH-CO-NH-Lys-(Ahx) [Ga(HBED-CC)] [Ga prostate-specific membrane antigen-11 (PSMA-11)] PET with multiparametric MRI (mpMRI) for the staging of high-risk prostate cancer. |
The median age of the 36 patients included was 65 years (range: 44-80 years) and the median prostate specific antigen was 94.3 ng/ml (range: 20-19005 ng/ml). Concordance for localization of primary on Ga-PSMA PET/CT and MRI was observed in 19/36 (52.7%) patients. Concurrence for T staging on Ga-PSMA and MRI was observed in 58.3% of patients. Ga-PSMA PET/CT detected higher numbers of patients with regional (29) and nonregional (15) lymph nodes in comparison with MRI (20 and 5, respectively). Concurrence for regional and nonregional lymph node staging was observed in 72.2% of patients. Additional sites of metastatic disease reported on Ga-PSMA PET/CT were to the skeleton in one patient, the lung in two patients, and the liver in one patient. |
2 |
| 118. Han S, Woo S, Kim YJ, Suh CH. Impact of 68Ga-PSMA PET on the Management of Patients with Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 74(2):179-190, 2018 08. |
Meta-analysis |
15 studies |
To perform a systematic review and meta-analysis to evaluate the impact of 68Ga-PSMA PET on management of patients with prostate cancer. |
Fifteen studies (1163 patients) were included. The pooled proportion of management changes was 54% (95% confidence interval 47-60%). At meta-regression analyses, PET positivity (%) was a significant factor of heterogeneity (p=0.0486). For patients with biochemical failure, the proportion of radiotherapy (from 56% to 61%), surgery (from 1% to 7%), focal therapy (from 1% to 2%), and multimodal treatment (from 2% to 6%) increased, whereas that of systemic treatment (from 26% to 12%) and no treatment (from 14% to 11%) decreased with 68Ga-PSMA PET. |
Good |
| 119. Hofman MS, Lawrentschuk N, Francis RJ, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 395(10231):1208-1216, 2020 04 11. |
Observational-Dx |
339 men |
To investigate whether novel imaging using prostate-specific membrane antigen (PSMA) PET-CT might improve accuracy and affect management. |
From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001). We found a lower sensitivity (38% [24-52] vs 85% [74-96]) and specificity (91% [85-97] vs 98% [95-100]) for conventional imaging compared with PSMA PET-CT. Subgroup analyses also showed the superiority of PSMA PET-CT (area under the curve of the receiver operating characteristic curve 91% vs 59% [32% absolute difference; 28-35] for patients with pelvic nodal metastases, and 95% vs 74% [22% absolute difference; 18-26] for patients with distant metastases). First-line conventional imaging conferred management change less frequently (23 [15%] men [10-22] vs 41 [28%] men [21-36]; p=0·008) and had more equivocal findings (23% [17-31] vs 7% [4-13]) than PSMA PET-CT did. Radiation exposure was 10·9 mSv (95% CI 9·8-12·0) higher for conventional imaging than for PSMA PET-CT (19·2 mSv vs 8·4 mSv; p<0·001). We found high reporter agreement for PSMA PET-CT (?=0·87 for nodal and ?=0·88 for distant metastases). In patients who underwent second-line image, management change occurred in seven (5%) of 136 patients following conventional imaging, and in 39 (27%) of 146 following PSMA PET-CT. |
2 |
| 120. Lengana T, Lawal IO, Boshomane TG, et al. 68Ga-PSMA PET/CT Replacing Bone Scan in the Initial Staging of Skeletal Metastasis in Prostate Cancer: A Fait Accompli?. Clin Genitourin Cancer. 16(5):392-401, 2018 10. |
Observational-Dx |
113 patients |
To evaluate the use of 68Ga-PSMA positron emission tomography/computed tomography (PET/CT) in patients with prostate cancer and compared the results to those for technetium-99m (99mTc)-10-metacyloyloxydecyl dihydrogen phosphate (MDP) bone scintigraphy (BS). |
Ninety-one bone lesions were interpreted as bone metastases in 25 men undergoing 68Ga-PSMA PET/CT compared to only 61 lesions in 19 men undergoing 99mTc-MDP BS. Of the 7 bone scans that missed skeletal metastases, 54% of these missed lesions were due to either marrow or lytic skeletal metastases. The median standardized uptake value in all malignant bone lesions was 13.84. 68Ga-PSMA PET/CT showed significantly higher sensitivity and accuracy than BS (96.2% vs. 73.1%, and 99.1% vs. 84.1%) for the detection of skeletal lesions. For extraskeletal lesions, 68Ga-PSMA PET/CT showed an additional 96 unexpected lesions with a median standardized uptake value of 17.6. |
2 |
| 121. Maurer T, Gschwend JE, Rauscher I, et al. Diagnostic Efficacy of (68)Gallium-PSMA Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer. J Urol. 195(5):1436-1443, 2016 May. |
Observational-Dx |
130 patients |
To 1) investigate the diagnostic efficacy of (68)Ga-PSMA-PET imaging for lymph node staging in patients with prostate cancer scheduled for radical prostatectomy and 2) compare it to morphological imaging (computerized tomography and magnetic resonance tomography) with histopathological evaluation as the standard of reference. |
Lymph node metastases were found in 41 of 130 patients (31.5%). On patient based analysis the sensitivity, specificity and accuracy of (68)Ga-PSMA-PET were 65.9%, 98.9% and 88.5%, and those of morphological imaging were 43.9%, 85.4% and 72.3%, respectively. Of 734 dissected lymph node templates 117 (15.9%) showed metastases. On template based analysis the sensitivity, specificity and accuracy of (68)Ga-PSMA-PET were 68.3%, 99.1% and 95.2%, and those of morphological imaging were 27.3%, 97.1% and 87.6%, respectively. On ROC analysis (68)Ga-PSMA-PET performed significantly better than morphological imaging alone on patient and template based analyses (p = 0.002 and <0.001, respectively). |
2 |
| 122. Thalgott M, Duwel C, Rauscher I, et al. One-Stop-Shop Whole-Body 68Ga-PSMA-11 PET/MRI Compared with Clinical Nomograms for Preoperative T and N Staging of High-Risk Prostate Cancer. Journal of Nuclear Medicine. 59(12):1850-1856, 2018 12. |
Observational-Dx |
102 patients |
To assess the diagnostic potential of 1-stop-shop prostate-specific membrane antigen ligand (68Ga-PSMA-11) PET/MRI compared with preoperative staging nomograms in patients with high-risk prostate cancer. |
Seventy-three patients were finally analyzed. On a cohort basis, the MSKCC nomogram (39.7%) positivity rate was most concordant with pathologic prevalence for LNM (34.3%) compared with Partin tables (14.1%) and imaging (20.6%). Prevalence of ECE (72.6%) was best predicted by MSKCC nomograms and imaging (83.6% each), compared with Partin tables (38.4%). For prevalence of SVI (45.2%), imaging (47.9%) performed superior to MSKCC (37.6%) and Partin tables (19.3%). On a patient basis, AUCs for LNM, ECE, and SVI did not differ significantly between tests (P > 0.05). Imaging revealed a high specificity (100%) for LNM and a sensitivity (60%) comparable to the MSKCC nomogram (68%) and Partin tables (60%). For ECE, imaging revealed the highest sensitivity (94.3%) compared with the MSKCC nomogram (66%) and Partin tables (71.1%). For SVI, sensitivity and specificity of imaging and the MSKCC nomogram were comparable (81.5% and 80% vs. 87.9% and 75%). The rate of concordance to the final pTN stage was 60.3% for imaging, 52.1% for the MSKCC nomogram, and 39.7% for Partin tables. |
3 |
| 123. Kuten J, Fahoum I, Savin Z, et al. Head-to-Head Comparison of 68Ga-PSMA-11 with 18F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard. J Nucl Med. 61(4):527-532, 2020 04. |
Observational-Dx |
16 patients |
To compare the diagnostic accuracy of 18F-PSMA-1007 with 68Ga-PSMA-11 PET/CT in the same patients presenting with newly diagnosed intermediate- or high-risk PCa. |
PSMA-avid lesions in the prostate were identified in all 16 patients with an almost perfect concordance between the 2 tracers (? ranged from 0.871 to 1). Aside from the dominant intraprostatic lesion, similarly detected by both radiotracers, a second less intense positive focus was detected in 4 patients only with 18F-PSMA-1007. Three of these secondary foci were confirmed as Gleason grade 3 lesions, whereas the fourth was shown on pathologic examination to represent chronic prostatitis. |
3 |
| 124. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://www.acr.org/-/media/ACR/Files/Appropriateness-Criteria/RadiationDoseAssessmentIntro.pdf. |
Review/Other-Dx |
N/A |
To provide evidence-based guidelines on exposure of patients to ionizing radiation. |
No abstract available. |
4 |
