The PRECISION trial showed that MRI-guided prostate cancer (PCa) diagnosis was superior to 12-core systematic Transrectal ultrasound-guided (TRUS) biopsy. The EAU guidelines recommend transperineal (TP) biopsy, and more biopsy cores can be taken under TP approach (≥24 cores) in the Ginsburg protocol. This study aims to compare the detection of clinically significant PCa (csPCa) using MRI-guided TP biopsy approach and the 24-core TP systematic biopsy.

This multicenter, phase III, randomized controlled trial (NCT04685928) involved patients from 8 hospitals. Patients with elevated PSA 4-20 ng/mL with or without abnormal digital rectal examination (DRE) were randomized in a 1:1 manner to MRI-arm or TP-arm. Patients in MRI-arm received multiparametric MRI prostate(mpMRI), followed by MRI-targeted biopsy and 12-core systematic TP biopsy if PI-RADS score ≥3. No biopsy was performed if PI-RADS score was 1-2. In TP arm, all patients received 24-core TP systematic biopsy (TP-arm). All biopsies were performed under local anaesthesia. The primary outcome was the detection rates of csPCa, defined as ISUP grade group ≥2 PCa. Secondary outcomes included csPCa detection rates in participants with MRI-targeted only biopsy compared to those in TP-arm, clinically insignificant prostate cancer (ISUP 1) detection rates, proportion of men in MRI-arm with normal MRI findings who avoided a biopsy, and adverse events(AE) within 30 days.

A total of 502 participants underwent randomization from May 2021 to November 2023, with 17 withdrawals after randomization (4 in MRI-arm, 13 in TP-arm). The analysis was based on the intention-to-treat principle. Median PSA, Prostate volume and PSA density were 7.0 (IQR 5.3-10.3) ng/mL, 54.0 (39.0-70.0) ml, and 0.14 (0.10-0.21) ng/mL/mL, respectively. In MRI-arm, 43.8% (109/249) had PI-RADS score ≤2 and avoided biopsy. The primary outcome, csPCa, was detected in 23.3% (58/249) of MRI-arm and 27.7% (70/253) of TP-arm (p=0.26). The absolute difference was -4.7% [95% confidence interval (CI): -12.4%, 2.9%]. Detection of csPCa in MRI-arm with only targeted biopsy was 20.5% (51/249), p=0.06 comparing with 27.7% (70/253) in TP-arm. With more biopsies performed in TP-arm, more ISUP group 1 cases were detected in TP-arm (14.6%, 37/253) than MRI-arm (9.2%, 23/249) (p=0.07). Any grade adverse events (AE) occurred in 43.3% (104/240) in TP-arm and 24.8% (60/242) in MRI-arm (p<0.001). When excluding patients with negative MRI results in the MRI-arm, the proportion of AE was 42.9% (60/140).

In TP biopsy setting, there was no statistically significant difference in the detection of csPCa in MRI-arm and TP-arm. However, MRI approach reduced 43.8% unnecessary biopsies and 37.8% ISUP group 1 PCa diagnosis. If MRI is not easily available, an extended TP systematic biopsy is a valid alternative for csPCa detection.