Prostate cancer detection by MRI-ultrasonography fusion transperineal vs transrectal biopsy: a randomised control trial.

[OBJECTIVE] To compare clinically significant prostate cancer (CS-PCa) detection by transperineal (TP) compared to transrectal (TR) magnetic resonance imaging (MRI)-ultrasonography (US) fusion prostate biopsy.

[PATIENTS AND METHODS] Males with abnormal prostate MRI (one or more lesion[s], Prostate Imaging-Reporting and Data System [PI-RADS] score ≥3) consenting to prostate biopsy were enrolled in a randomised control trial (NCT03936127) performed at single-site tertiary care referral centre from October 2022 to June 2024. The patients were randomised to either TP or TR biopsy approach. The primary outcome was CS-PCa (International Society of Urogenital Pathology Grade Group ≥2). Subgroup analysis of the primary outcome was stratified by lesion location (posterior, anterior; and apex, middle, base) and PI-RADS score. Secondary outcomes were detection of any grade PCa, infection, and patient pain score.

[RESULTS] In total, 233 patients were randomised (119 patients with 168 lesions in the TP group and 114 patients with 151 lesions in the TR group). CS-PCa was detected in: 61% (73/119; 95% confidence interval [CI] 52-70%) for TP and 54% (62/114; 95% CI 45-64%) for TR (relative risk [RR] 1.13, 95% CI 0.93-1.38, P = 0.23). Adjusted CS-PCa detection rates were higher for TP in anterior lesions: 29% (95% CI 15-49%) vs 16% (95% CI 7-31%) (RR 1.81, 95% CI 1.05-3.12; P = 0.03) and PI-RADS score 4 lesions: 51% (95% CI 39-62%) vs 30% (95% CI 19-43%) (RR 1.77, 95% CI 1.13-2.76; P = 0.01), with no difference in apical lesions (RR 0.91, 95% CI 0.60-1.37; P = 0.65). The median (interquartile range) pain score was 3 (2-4) in the TP group and 2 (1-5) in the TR group (P = 0.09). There were no urinary tract infections or urosepsis events in either group. No patient was withdrawn due to adverse events.

[CONCLUSIONS] In this trial, we failed to demonstrate a statistically significant, increase in the detection of CS-PCa using TP compared to TR biopsy. There were no sepsis events and biopsy was tolerated in both patient groups. MRI-US fusion prostate biopsy using a TP approach may be more advantageous for anterior and smaller lesions, higher powered studies are needed.