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 No patient was withdrawn due to adverse events.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.