Creating a novel multiparametric magnetic resonance imaging-based biopsy strategy for reducing unnecessary prostate biopsies: a retrospective cohort study.

Background:The overdiagnosis of prostate cancer (PCa) caused by unnecessary prostate biopsy has become a worldwide problem that urgently requires a solution. We aimed to reduce the unnecessary prostate biopsies and increase the detection rate of clinically significant PCa (csPCa) by creating a novel multiparametric magnetic resonance imaging (mpMRI)-based strategy. Methods:A total of 1,194 eligible patients who underwent transperineal prostate biopsies from January 2018 to December 2022 were included in this retrospective study. Of these patients, 1,080 who received prostate biopsies from January 2018 to July 2022 were regarded as cohort 1 for primary analysis, and 114 patients who received prostate biopsies from August 2022 to December 2022 were collected in cohort 2 for validation. All the mpMRI images were quantitatively evaluated by the Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v. 2.1). The diagnostic performances were assessed through the receiver operating characteristic (ROC) curve and area under the curve (AUC) and were compared with the DeLong test. Cancer diagnosis-free survival analysis was performed using the Kaplan-Meier method and log-rank test. The primary endpoint of this study was clinically significant PCa with an International Society of Urological Pathology (ISUP) grade ≥2. Results:In cohort 1, the results of ROC curves demonstrated that the PI-RADS score had a higher diagnostic accuracy (AUC =0.898 for any-grade PCa; AUC =0.917 for csPCa) than did the other clinical variables (P<0.001). Under the novel mpMRI-based biopsy strategy, all patients with PI-RADS 1 can safely avoid prostate biopsy. For patients with PI-RADS 2, prostate biopsy should be considered for patients with prostate-specific antigen density (PSAD) ≥0.3 ng/mL2 and prostate volume <65 mL. As for patients with PI-RADS 3, structured surveillance programs can be a viable option if PSAD <0.3 ng/mL2 and prostate volume ≥65 mL. Finally, patients with a PI-RADS score of 4 and 5 should undergo prostate biopsy due to the high probability of clinically significant PCa. In the validation analysis of cohort 2, 48 patients were placed into a biopsy-spared group with no csPCa cases, while 66 patients were placed in a biopsy-needed group, with an csPCa detection rate of 50.0%. Overall, the novel strategy demonstrated a sensitivity, specificity, positive predictive value, and negative predictive value of 98.9%, 57.5%, 50.5%, and 99.2%, respectively, for diagnosing csPCa. Conclusions:An mpMRI-based biopsy strategy can effectively avoid about 40% of prostate biopsies and maintain a high detection rate for clinically significant PCa. It can further provide valuable guidance for patients and physicians in considering the necessity of prostate biopsy.