Transperineal MR Imaging-Guided Prostate Biopsy: A Prospective Randomized Controlled Study on Safety and Effectiveness Compared with Transrectal Biopsy.

PURPOSE: This study aimed to evaluate the safety and tolerability of magnetic resonance (MR) imaging-guided in-bore transperineal prostate biopsies (TP-Bx).

MATERIALS AND

METHODS

A single-center, prospective randomized controlled trial was conducted from April 2016 to March 2022. Ninety patients were randomized 1:1 into 2 groups: (a) transrectal biopsies (TR-Bx) under local anesthesia and (b) MR imaging-guided TP-Bx under general anesthesia. Patients with suspected prostate cancer (PCa) with negative prior biopsies and patients with low-risk PCa under active surveillance (AS) were included. Data on clinical, biological, radiological, and histological characteristics were collected. Primary endpoint assessed safety through adverse event rates; secondary endpoints included cancer detection rate (CDR), clinically significant CDR (csCDR), and tolerability based on quality-of-life questionnaires.

RESULTS

Among the 90 participants, 27 (30%) were under AS. Adverse events occurred in 8.9% of TR-Bx patients and 4.4% of TP-Bx patients, with no significant difference between groups (P = .809). TP-Bx demonstrated a higher CDR (42.5%) than TR-Bx (28.2%) and a significantly higher csCDR (27.5% vs 7.7%, P = .019). Quality-of-life and pain assessments showed no significant differences between groups, although changes in management were more frequent following TP-Bx (32.5% vs 15.4%, P = .050).

CONCLUSIONS

MR imaging-guided TP-Bx is a safe and effective procedure with an enhanced detection rate in non-biopsy-naïve patients, leading to adjustments in management strategies. Future studies should further evaluate TP-Bx for specific patient subgroups, such as those under AS or candidates for focal treatment.