Prostate Imaging Reporting And Data System Version 2 Category Research Articles

Comparison of multiple abbreviated multiparametric MRI-derived protocols for the detection of clinically significant prostate cancer.

The aim of this paper was to compare the accuracy of multiple abbreviated multiparametric magnetic resonance imaging (mpMRI)-derived protocols in detecting clinically significant prostate cancer (csPCa). One hundred and eight men undergoing staging 3.0T mpMRI with a Prostate Imaging - Reporting and Data System version 2 (PI-RADSv2)-compliant protocol before radical prostatectomy (RP) were retrospectively evaluated. Two readers (R1, R2) independently analyzed mpMRI, assigning a PI-RADSv2 category to each observation as appearing on each examination sequence. A study coordinator assessed final PI-RADSv2 category by combining readers' assignments according to four protocols: short MRI (sMRI) (diffusion-weighted imaging + axial T2-weighted imaging), contrast-enhanced short MRI (cesMRI) (sMRI + dynamic contrast-enhanced [DCE] imaging), biparametric MRI (diffusion-weighted imaging + multiplanar T2-weigthed imaging), and mpMRI. Using RP pathology as the reference standard for csPCa, we calculated the per-lesion cancer detection rate (CDR) and false discovery rate (FDR) for each MRI protocol (cut-off PI-RADSv2 category ≥3), and the per-PI-RADSv2 category prevalence of csPCa and false positives. Pathology after RP found 142 csPCas with median International Society of Urogenital Pathology grade group 2, and stage ≤pT2c in 68.6% of cases. CDR was comparable across the four MRI protocols (74.6% to 75.3% for R1, and 68.3% for R2). FDR was comparable as well (14.4%-14.5% for R1 and 11.1% for R2). sMRI was the minimum protocol equaling mpMRI in terms of CDR, although cesMRI, similarly to mpMRI, was associated with fewer PI-RADSv2 category 3 assignments and higher prevalence of csPCa within PI-RADSv2 category 3 observations (66.7% versus 76.9% for R1, and 100% versus 91.7% for R2, respectively). Among multiple abbreviated mpMRI-derived protocols, cesMRI was the one equaling mpMRI in terms of csPCa detection and minimizing PI-RADSv2 category 3 assignments.

Postoperative Biochemical Failure in Patients With PI-RADS Category 4 or 5 Prostate Cancers: Risk Stratification According to Zonal Location of an Index Lesion

OBJECTIVE. The objective of our study was to assess postoperative biochemical failure in patients with prostate cancer according to zonal location of an index lesion classified as Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) category 4 or 5. MATERIALS AND METHODS. Consecutive patients (n = 232) with prostate cancer who had PI-RADSv2 category 4 or 5 lesions on MRI and who underwent radical prostatectomy were retrospectively evaluated. We investigated clinical (prostate-specific antigen density), MRI (PI-RADSv2 category of index lesion and zonal location, assessed as peripheral zone [PZ] or transition zone [TZ], of index lesion), and pathologic (tumor volume, tumor grade, and presence of extraprostatic extension) parameters. We analyzed Kaplan-Meier survival curves and the Cox proportional hazards model to assess 2-year biochemical failure-free survival and identify significant parameters associated with postoperative biochemical failure RESULTS. Biochemical failure occurred in 14.2% of patients (33/232). Two-year biochemical failure-free survival of patients with a PI-RADSv2 category 4 or 5 index lesion was 81.3%. For all patients, 2-year biochemical failure-free survival was different according to PI-RADSv2 category (category 4, 86.4%; category 5, 74.5%; p = 0.021) or zonal location (PZ, 75.3%; TZ, 96.8%; p = 0.003). Two-year biochemical failure-free survival in patients with category 4 lesions was similar in patients with PZ lesions (83.1%) and those with TZ lesions (100.0%) (p = 0.072), whereas it was different in patients with category 5 lesions (PZ, 62.0%; TZ, 95.0%; p = 0.002). In multivariate analysis, only zonal location of an index lesion on MRI was associated with biochemical failure (hazard ratio = 0.155; p = 0.012). CONCLUSION. Zonal location of an index lesion on MRI may be a useful imaging bio-marker to predict postoperative biochemical failure.

Comparing Prostate Imaging-Reporting and Data System Version 2 (PI-RADSv2) Category 1 and 2 Groups: Clinical Implication of Negative Multiparametric Magnetic Resonance Imaging.

Objectives To evaluate the clinicopathological differences between Prostate Imaging-Reporting and Data System (PI-RADS) version 2 (v2) category 1 and 2 groups. Materials and Methods. We retrospectively reviewed our two institutional clinical databases: (1) transrectal ultrasound (TRUS)/magnetic resonance imaging (MRI) fusion biopsy cohort (n = 706) and (2) radical prostatectomy (RP) cohort (n = 1403). Subsequently, we performed comparative analyses between PI-RADSv2 category 1 and 2 groups. Clinically significant prostate cancer (csPCa) was defined as the presence of Gleason score (GS) ≥ 3 + 4 in a single biopsy core, and adverse pathology (AP) was defined as high-grade (primary Gleason pattern 4 or any pattern 5) and/or non-organ-confined disease (pT3/N1). We also performed multivariate logistic regression analyses for AP. Results In the TRUS/MRI fusion biopsy cohort, no significant differences in detection rates of all cancer (18.2% vs. 29.0%, respectively, P = 0.730) or csPCa (9.1% vs. 9.9%, respectively, P = 0.692) were observed between PI-RADSv2 category 1 and 2 groups. There were no significant differences in pathologic outcomes including Gleason score (≥4 + 3, 21.2% vs. 29.9%, respectively, P = 0.420) or detection rate of AP (27.3% vs. 33.8%, respectively, P = 0.561) between the two groups in the RP cohort either. PI-RADSv2 category 1 or 2 had no significant association with AP, even in univariate analysis (P = 0.299). Conclusions PI-RADSv2 categories 1 and 2 had similar performance to predict clinicopathological outcomes. Consequently, these two categories may be unified into a single category. Negative mpMRI does not guarantee the absence of AP, as with csPCa.

Dynamic Contrast-Enhanced MRI-Upgraded Prostate Imaging Reporting and Data System Version 2 Category 3 Peripheral Zone Observations Stratified by a Size Threshold of 15 mm.

OBJECTIVE. The purpose of this study is to evaluate dynamic contrast-enhanced (DCE) MRI (DCE-MRI)-upgraded Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) peripheral zone (PZ) observations stratified by a size threshold of 15 mm. MATERIALS AND METHODS. Two blinded radiologists independently assessed 301 patients with 326 clinically significant tumors (Gleason score [GS] ≥ 7) using multiparametric MRI performed before radical prostatectomy (RP) between 2012 and 2017 and then assigned PI-RADSv2 scores for the tumors. PI-RADSv2 category 3 PZ observations upgraded on the basis of abnormal DCE-MRI findings were tabulated, agreement was calculated, and discrepancies were resolved by consensus. The rate of detection of clinically significant cancer among upgraded observations was calculated. Size was measured at consensus review and was compared with pathologic outcomes on the basis of the PI-RADSv2 size threshold of 15 mm or more, with the use of chi-square tests. RESULTS. Reader 1 identified 5.2% (17/326) of DCE-MRI-upgraded PZ observations, and reader 2 identified 8.3% (27/326) of such observations. Interobserver agreement for PI-RADSv2 scoring was moderate (κ = 0.42) overall, but it was fair (κ = 0.23) when only DCE-MRI-upgraded observations were considered. Of the upgraded observations, which had a mean (± SD) size of 14 ± 6 mm (range, 6-29 mm), 10.4% (34/326) were agreed on after consensus review. Size smaller than 15 mm was noted for 61.8% (21/34) of observations. Among DCE-MRI-upgraded PZ observations, true- and false-positive detection rates for significant cancer were 91.2% (31/34) and 8.8% (3/34), respectively. Observations 15 mm or larger had no false-positive diagnoses and higher rates of extraprostatic extension (84.6% [11/13] vs 38.1% [8/21]; p = 0.016); however, there was no difference in GS (p = 0.354) compared with observations less than 15 mm in size. CONCLUSION. PZ observations upgraded on the basis of abnormal DCE-MRI findings have a high likelihood of being clinically significant cancer; however, agreement between readers was low. DCE-MRI-upgraded tumors of 15 mm or larger had no false-positive diagnoses and higher rates of extraprostatic extension, suggesting that they could be assigned to PI-RADSv2 assessment category 5.

Detection and Localization of Prostate Cancer at 3-T Multiparametric MRI Using PI-RADS Segmentation.

OBJECTIVE. The purpose of this study is to determine the overall and sector-based performance of 3-T multiparametric MRI for prostate cancer (PCa) detection and localization by using Prostate Imaging-Reporting and Data System version 2 (PI-RADSv2) scoring and segmentation compared with whole-mount histopathologic analysis. MATERIALS AND METHODS. Multiparametric 3-T MRI examinations of 415 consecutive men were compared with thin-section whole-mount histopathologic analysis. A genitourinary radiologist and pathologist collectively determined concordance. Two radiologists assigned PI-RADSv2 categories and sectoral location to all detected foci by consensus. Tumor detection rates were calculated for clinical and pathologic (Gleason score) variables. Both rigid and adjusted sector-matching models were used to account for fixation-related issues. RESULTS. The 415 patients had 863 PCa foci (52.7% had a Gleason score ≥ 7, 61.9% were ≥ 1 cm, and 90.4% (375/415) of index lesions were ≥ 1 cm) and 16,185 prostate sectors. Multiparametric MRI enabled greater detection of PCa lesions 1 cm or larger (all lesions vs index lesions, 61.6% vs 81.6%), lesions with Gleason score greater than or equal to 7 (all lesions vs index lesions, 71.4% vs 80.9%), and index lesions with both Gleason score greater than or equal to 7 and size 1 cm or larger (83.3%). Higher sensitivity was obtained for adjusted versus rigid tumor localization for all lesions (56.0% vs 28.5%), index lesions (55.4% vs 34.3%), lesions with Gleason score greater than or equal to 7 (55.7% vs 36.0%), and index lesions 1 cm or larger (56.1% vs 35.0%). Multiparametric 3-T MRI had similarly high specificity (96.0-97.9%) for overall and index tumor localization with adjusted and rigid sector-matching approaches. CONCLUSION. Using 3-T multiparametric MRI and PI-RADSv2, we achieved the highest sensitivity (83.3%) for the detection of lesions 1 cm or larger with Gleason score greater than or equal to 7. Sectoral localization of PCa within the prostate was moderate and was better with an adjusted model than with a rigid model.

Interreader Variability of Prostate Imaging Reporting and Data System Version 2 in Detecting and Assessing Prostate Cancer Lesions at Prostate MRI.

OBJECTIVE. The purpose of this study was to evaluate agreement among radiologists in detecting and assessing prostate cancer at multiparametric MRI using Prostate Imaging Reporting and Data System version 2 (PI-RADSv2). MATERIALS AND METHODS. Treatment-naïve patients underwent 3-T multipara-metric MRI between April 2012 and June 2015. Among the 163 patients evaluated, 110 underwent prostatectomy after MRI and 53 had normal MRI findings and transrectal ultrasound-guided biopsy results. Nine radiologists participated (three each with high, intermediate, and low levels of experience). Readers interpreted images of 58 patients on average (range, 56-60) using PI-RADSv2. Prostatectomy specimens registered to MRI were ground truth. Interob-server agreement was evaluated with the index of specific agreement for lesion detection and kappa and proportion of agreement for PI-RADS category assignment. RESULTS. The radiologists detected 336 lesions. Sensitivity for index lesions was 80.9% (95% CI, 75.1-85.9%), comparable across reader experience (p = 0.392). Patient-level specificity was experience dependent; highly experienced readers had 84.0% specificity versus 55.2% for all others (p < 0.001). Interobserver agreement was excellent for detecting index lesions (index of specific agreement, 0.871; 95% CI, 0.798-0.923). Agreement on PI-RADSv2 category assignment of index lesions was moderate (κ = 0.419; 95% CI, 0.238-0.595). For individual category assignments, proportion of agreement was slight for PI-RADS category 3 (0.208; 95% CI, 0.086-0.284) but substantial for PI-RADS category 4 (0.674; 95% CI, 0.540-0.776). However, proportion of agreement for T2-weighted PI-RADS 4 in the transition zone was 0.250 (95% CI, 0.108-0.372). Proportion of agreement for category assignment of index lesions on dynamic contrast-enhanced MR images was 0.822 (95% CI, 0.728-0.903), on T2-weighted MR images was 0.515 (95% CI, 0.430-0623), and on DW images was 0.586 (95% CI, 0.495-0.682). Proportion of agreement for dominant lesion was excellent (0.828; 95% CI, 0.742-0.913). CONCLUSION. Radiologists across experience levels had excellent agreement for detecting index lesions and moderate agreement for category assignment of lesions using PI-RADS. Future iterations of PI-RADS should clarify PI-RADS 3 and PI-RADS 4 in the transition zone.

A Systematic Review of the Existing Prostate Imaging Reporting and Data System Version 2 (PI-RADSv2) Literature and Subset Meta-Analysis of PI-RADSv2 Categories Stratified by Gleason Scores.

The objective of this study was to quantitatively and qualitatively assess the methodologic heterogeneity of the current Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) literature and estimate the proportions of Gleason scores (GSs) diagnosed across PI-RADSv2 categories. This study was a systematic review and meta-analysis and was performed in concordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Only English-language studies and studies published before April 1, 2018, were assessed. The primary outcome of the meta-analysis was the estimated percentage of patients with GS ≥ 3 + 4 within each individual PI-RADSv2 score. We calculated the pooled estimates and 95% CIs on the basis of a random-effects model using the meta-analysis routine of Stata (version 13.1). Our search revealed 434 titles, and 59 of these studies were selected. These studies were remarkable for their technical and terminological diverseness. Thirteen studies had sufficient data to be included in the meta-analysis. The prevalence of ≥ GS 3 + 4 in lesions assigned a PI-RADSv2 score of 3 or higher was approximately 45%. Lesions assigned PI-RADSv2 scores 1 or 2, 3, 4, and 5 represented high-grade disease in approximately 6%, 12%, 48%, and 72% of patients. The data available in the literature are highly heterogeneous and challenging to analyze because of variations in terminology, patient cohort selection, criteria, imaging parameters, and reference standards. In spite of this heterogeneity, our meta-analysis shows that PI-RADSv2 has good sensitivity when a score of ≥ 3 is considered as a positive test.

Can Apparent Diffusion Coefficient Values Assist PI-RADS Version 2 DWI Scoring? A Correlation Study Using the PI-RADSv2 and International Society of Urological Pathology Systems.

The purposes of this study were to assess correlation of apparent diffusion coefficient (ADC) and normalized ADC (ratio of tumor to nontumor tissue) with the Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) and updated International Society of Urological Pathology (ISUP) categories and to determine how to optimally use ADC metrics for objective assistance in categorizing lesions within PI-RADSv2 guidelines. In this retrospective study, 100 patients (median age, 62 years; range, 44-75 years; prostate-specific antigen level, 7.18 ng/mL; range, 1.70-84.56 ng/mL) underwent 3-T multiparametric MRI of the prostate with an endorectal coil. Mean ADC was extracted from ROIs based on subsequent prostatectomy specimens. Histopathologic analysis revealed 172 lesions (113 peripheral, 59 transition zone). Two radiologists blinded to histopathologic outcome assigned PI-RADSv2 categories. Kendall tau was used to correlate ADC metrics with PI-RADSv2 and ISUP categories. ROC curves were used to assess the utility of ADC metrics in differentiating each reader's PI-RADSv2 DWI category 4 or 5 assessment in the whole prostate and by zone. ADC metrics negatively correlated with ISUP category in the whole prostate (ADC, τ = -0.21, p = 0.0002; normalized ADC, τ = -0.21, p = 0.0001). Moderate negative correlation was found in expert PI-RADSv2 DWI categories (ADC, τ = -0.34; normalized ADC, τ = -0.31; each p < 0.0001) maintained across zones. In the whole prostate, AUCs of ADC and normalized ADC were 87% and 82% for predicting expert PI-RADSv2 DWI category 4 or 5. A derived optimal cutoff ADC less than 1061 and normalized ADC less than 0.65 achieved positive predictive values of 83% and 84% for correct classification of PI-RADSv2 DWI category 4 or 5 by an expert reader. Consistent relations and predictive values were found by an independent novice reader. ADC and normalized ADC inversely correlate with PI-RADSv2 and ISUP categories and can serve as quantitative metrics to assist with assigning PI-RADSv2 DWI category 4 or 5.

Effect of Combined 68Ga-PSMAHBED-CC Uptake Pattern and Multiparametric MRI Derived With Simultaneous PET/MRI in the Diagnosis of Primary Prostate Cancer: Initial Experience.

The purpose of this study is to assess whether temporal changes in 68Ga-prostate-specific membrane antigen (PSMA)-HBED-CC uptake and multiparametric MRI parameters derived using PET/MRI can aid in characterization of benign and malignant prostate lesions. Thirty-five men with 29 malignant and six benign prostate lesions undergoing complete clinical workup including histologic analysis were enrolled for this retrospective study. All had undergone simultaneous whole-body 68Ga-PSMAHBED-CC PET/MRI. Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) assessment was made using a 5-point scale showing the likelihood of cancer with the combination of multiparametric MRI findings. Gallium-68-PSMA uptake was recorded at two time points: early (7 minutes) and delayed (54 minutes), adopting a copy-and-paste function of the ROI defined on MR images. ROC curve analysis was performed to test the diagnostic accuracy of early versus delayed PSMA uptake (measured as maximum standardized uptake value [SUV]). A multiple-ROI analysis was done to obtain ROCs for combined PET SUV and multiparametric MRI datasets. Spearman analysis was performed to assess the correlations. There was a significant difference between early and delayed PSMA uptake in malignant prostatic lesions (p < 0.01), which was able to characterize prostate lesions with an AUC of 0.83 and 0.94. Combined ROC analysis of PI-RADSv2 category derived from multiparametric MRI and differential PSMA uptake in characterizing prostatic lesions improved the AUC to 0.99. Dual-phase PSMA uptake improves accuracy of classifying malignant versus benign prostate lesions and complements multiparametric MRI in the diagnosis of prostate cancer.

Comparison of Prostate Imaging Reporting and Data System versions 1 and 2 for the Detection of Peripheral Zone Gleason Score 3 + 4 = 7 Cancers

The objective of our study was to compare Prostate Imaging Reporting and Data System version 1 (PI-RADSv1) and Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) for the detection of peripheral zone (PZ) Gleason score 3 + 4 = 7 cancers. Forty-seven consecutive patients with 52 PZ Gleason score 3 + 4 = 7 cancers that were 0.5 cm3 or larger underwent radical prostatectomy (RP) and 3-T MRI between 2012 and 2015. Two blinded radiologists (readers 1 and 2) retrospectively assigned PI-RADSv1 sequence (T2-weighted imaging, DWI, dynamic contrast-enhanced MRI [DCE-MRI]) and sum scores and PI-RADSv2 assessment categories. A third blinded radiologist (reader 3) measured apparent diffusion coefficient (ADC) ratio (ADC of tumor / ADC of normal PZ) using RP-MRI maps. Sensitivity, false-positive rate, and overall accuracy were compared using McNemar test. Pearson correlation was performed. Using PI-RADSv1, reader 1 detected 86.5% (45/52) of the cancers and reader 2, 76.9% (40/52) of the cancers. Using PI-RADSv2, reader 1 detected 78.9% (41/52) and reader 2, 67.3% (35/52). Reader 1 detected 7.7% (4/52) and reader 2 detected 9.6% (5/52) more tumors using PI-RADSv1 due to T2-weighted imaging score ≥ 4 or DCE-MRI score ≥ 3. Sensitivity was higher for PI-RADSv1 (p = 0.01 and 0.03, readers 1 and 2). False-positive rates were higher with PI-RADSv1 than with PI-RADSv2 (1.8% vs 0.9% for reader 1; 3.6% vs 1.8% for reader 2) without significant differences in false-positive rate (p = 0.41 and 0.25) or overall accuracy (p = 0.06 and 0.23). PI-RADSv1 sum scores correlated strongly with PI-RADSv2 categories (B = 0.78-0.93, p < 0.0001). The mean ADC ratio was 0.61 ± 0.14 mm2/s with no difference between visible and nonvisible tumors (p = 0.06-0.5). Interobserver agreement was moderate for PI-RADSv2 (κ = 0.41) and ranged from slight to substantial for PI-RADSv1 (T2-weighted imaging, κ = 0.32; DWI, κ = 0.52; DCE-MRI, κ = 0.13). There was no difference in overall detection of cancers comparing PI-RADSv1 and PI-RADSv2; however, PI-RADSv1 sequence scores on T2-weighted imaging and DCE-MRI detected approximately 10% more tumors that were otherwise underestimated on DWI and using PI-RADSv2 decision-tree rules.

Risk Stratification Among Men With Prostate Imaging Reporting and Data System version 2 Category 3 Transition Zone Lesions: Is Biopsy Always Necessary?

The objective of our study was to determine the clinical and MRI characteristics of clinically significant prostate cancer (PCA) (Gleason score ≥ 3 + 4) in men with Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) category 3 transition zone (TZ) lesions. From 2014 to 2016, 865 men underwent prostate MRI and MRI/ultrasound (US) fusion biopsy (FB). A subset of 90 FB-naïve men with 96 PI-RADSv2 category 3 TZ lesions was identified. Patients were imaged at 3 T using a body coil. Images were assigned a PI-RADSv2 category by an experienced radiologist. Using clinical data and imaging features, we performed univariate and multivariate analyses to identify predictors of clinically significant PCA. The mean patient age was 66 years, and the mean prostate-specific antigen density (PSAD) was 0.13 ng/mL2. PCA was detected in 34 of 96 (35%) lesions, 14 of which (15%) harbored clinically significant PCA. In univariate analysis, DWI score, prostate volume, and PSAD were significant predictors (p < 0.05) of clinically significant PCA with a suggested significance for apparent diffusion coefficient (ADC) and prostate-specific antigen value (p < 0.10). On multivariate analysis, PSAD and lesion ADC were the most important covariates. The combination of both PSAD of 0.15 ng/mL2 or greater and an ADC value of less than 1000 mm2/s yielded an AUC of 0.91 for clinically significant PCA (p < 0.001). If FB had been restricted to these criteria, only 10 of 90 men would have undergone biopsy, resulting in diagnosis of clinically significant PCA in 60% with eight men (9%) misdiagnosed (false-negative). The yield of FB in men with PI-RADSv2 category 3 TZ lesions for clinically significant PCA is 15% but significantly improves to 60% (AUC > 0.9) among men with PSAD of 0.15 ng/mL2 or greater and lesion ADC value of less than 1000 mm2/s.

Prostate Imaging Reporting and Data System, Version 2, Assessment Categories and Pathologic Outcomes in Patients With Gleason Score 3 + 4 = 7 Prostate Cancer Diagnosed at Biopsy.

The purpose of this study is to assess associations between Prostate Imaging Reporting and Data System, version 2 (PI-RADSv2), categories and the presence of a tumor with a Gleason score (GS) of 4 + 3 = 7 or greater or the presence of extraprostatic extension (EPE) at radical prostatectomy (RP) in patients with a GS 3 + 4 = 7 tumor at biopsy. A total of 81 men with GS 3 + 4 = 7 prostate cancer diagnosed by transrectal ultrasound-guided biopsy underwent multiparametric MRI and RP between 2012 and 2015. Two blinded radiologists assessed multiparametric MR images and assigned PI-RADSv2 assessment categories (categories 1-5) with the use of sector maps, which were compared with regard to the location of the tumor, the GS, and the presence of EPE at RP. Comparisons were performed between groups with the use of chi-square and multivariate analysis. Diagnostic accuracy was assessed using ROC curve analysis, and localization was compared using the Fisher exact test. A total of 53.1% of men (43/81) had EPE, and 21.0% (17/81) had GS 4 + 3 = 7 prostate cancer after RP, whereas 2.5% of men (2/81) had their tumors downgraded to GS 3 + 3 = 6. No statistically significant difference in patient age, prostate specific antigen level, or clinical stage existed between groups (p > 0.05). PI-RADSv2 assessment categories were significantly higher for GS 4 + 3 = 7 tumors (p = 0.03). PI-RADSv2 showed moderate accuracy for the diagnosis of GS 4 + 3 = 7 tumors (AUC, 0.65; 95% CI, 0.54-0.77), with a category of 4 or higher having a sensitivity and specificity for diagnosis of 94.1% and 23.4%, respectively. No patient with a PI-RADSv2 category lower than 3 had a GS 4 + 3 = 7 tumor. Accuracy of tumor localization ranged from 86.4% to 92.6%, with 88.2% of errors (15/17) occurring in GS 3 + 3 = 6 or GS 3 + 4 = 7 tumors (p = 0.30). PI-RADSv2 categories were noted to be higher when EPE was present (p < 0.001). Interobserver agreement was moderate (κ = 0.43). For GS 3 + 4 = 7 cancers detected at transrectal ultrasound-guided biopsy, higher PI-RADSv2 assessment categories are associated with upgrading to GS 4 + 3 = 7 cancer and with the presence of EPE after RP. A PI-RADSv2 score of 3 or higher was 100% sensitive for diagnosing GS 4 + 3 = 7 tumors.