Abstract

BackgroundMultiparametric magnetic resonance imaging (mpMRI) has excellent sensitivity in detecting significant prostate cancer (sPC). Nevertheless, uncertainty exists regarding the management of Prostate Imaging-Reporting and Data System (PI-RADS) 3 lesions. ObjectiveTo investigate whether PI-RADS 3 lesions in combination with clinical parameters, especially prostate-specific antigen density (PSAD), can be used to exclude sPC. Design, setting, and participantsA total of 455 consecutive biopsy-naïve men underwent MRI-guided transperineal prostate fusion biopsy at our department between 2017 and 2018. We identified 101 patients who had exclusively one or more PI-RADS 3 lesions on mpMRI. sPC was defined as intermediate- and high-risk PC (according to the D’Amico risk classification). Outcome measures and statistical analysisUnivariate logistic regression analysis was performed to test different clinical factors as predictors of sPC in men with PI-RADS 3 lesions. The probability of sPC prediction was calculated for different PSAD thresholds. Results and limitationsAmong patients with PI-RADS 3 lesions, PSAD was a significant predictor of sPC (p = 0.005). For a PI-RADS score of 3 the probability of excluding sPC was 85% (86/101), which increased to 98% (42/43) when combined with PSAD <0.1 ng/ml/ml. ConclusionsInclusion of PSAD < 0.1 ng/ml/ml in the strategy for biopsy-naïve patients with equivocal mpMRI findings would allow a reduction in prostate biopsies in 43% (43/101) of cases at the cost of missing a very small number (2%, 1/43) of intermediate-risk PCs. Patient summaryAt high-volume tertiary care centers with significant experience in prostate multiparametric magnetic resonance imaging, immediate biopsies could be safely omitted for men with lesions with a Prostate Imaging-Reporting and Data System score of 3 and prostate-specific antigen density of PSAD < 0.1 ng/ml/ml. Any decision to omit an immediate biopsy should be associated with close monitoring.

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