M ultiparametric MRI (mpMRI) has emerged as an integral part of the diagnostic pathway of prostate cancer (PCa) resulting in improved detection and localization of clinically significant PCa (csPCa). Multiple guidelines now recommend mpMRI before biopsy for all men with a clinical suspicion of csPCa (1-3). In a binary Prostate Imaging Reporting and Data System (PI-RADS)-directed biopsy pathway, men with intermediate (PI-RADS category 3) to high likelihood of csPCa (PI-RADS category 4 or 5) are considered for biopsy (4,5). The major challenges in using this approach clinically are the low positive predictive value (6,7) and moderate interreader and intercenter reproducibility (7,8). To reduce the number of false-positive mpMRI results and to improve the clinical benefits of an MRI pathway, additional laboratory and clinical factors may identify patients that can forego biopsy (1-4). Strategies for enhanced risk stratification include using prostate-specific antigen (PSA) density (PSAd) (9-14), other PSA-related analyses (15), or multivariable risk models incorporating . These models estimate the patient's risk of csPCa, which can guide decisions on prostate biopsy.Key aspects of prediction model performance are discrimination, calibration (ie, agreement between predicted Background: In validation studies, risk models for clinically significant prostate cancer (csPCa; Gleason score 314) combining multiparametric MRI and clinical factors have demonstrated poor calibration (over-and underprediction) and limited use in avoiding unnecessary prostate biopsies.Purpose: MRI-based risk models following local recalibration were compared with a strategy that combined Prostate Imaging Data and Reporting System (PI-RADS; version 2) and prostate-specific antigen density (PSAd) to assess the potential reduction of unnecessary prostate biopsies.
Materials and Methods: This retrospective study included 385 patients without prostate cancer diagnosis who underwent multiparametric MRI (PI-RADS category 3) and MRI-targeted biopsy between 2015 and 2019. Recalibration and selection of the bestperforming MRI model (MRI-European Randomized Study of Screening for Prostate Cancer [ERSPC], van Leeuwen, Radtke, and Mehralivand models) were undertaken in cohort C1 (n = 242; 2015-2017). The impact on biopsy decisions was compared with an alternative strategy (no biopsy for PI-RADS category 3 plus PSAd ,0.1 ng/mL per milliliter) in cohort C2 (n = 143; 2018-2019). Discrimination, calibration, and clinical utility were assessed by using the area under the receiver operating characteristic curve (AUC), calibration plots, and decision curve analysis, respectively.
Results:The prevalence of csPCa was 38% (93 of 242 patients) and 45% (64 of 143 patients) in cohorts C1 and C2, respectively. Decision curve analysis demonstrated the highest net benefit for the van Leeuwen and Mehralivand models in C1. Used for biopsy decisions in C2, van Leeuwen (AUC, 0.84; 95% CI: 0.77, 0.9) and Mehralivand (AUC, 0.79; 95% CI: 0.72, 0.86) enabled no net benefit at a r...