Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naïve Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial.

Abstract

The combined targeted and systematic biopsy (CTSBx) was the standard scheme for patients with visible suspicious lesions on MRI in recent years. 2024 European Association of Urology guideline recommended targeted and perilesional biopsy (TPLBx) for the diagnosis of patients with MRI-visible suspicious lesions. This randomized controlled trial aims to comprehensively evaluate the efficacy and safety profiles of TPLBx and CTSBx schemes. A single-center noninferiority randomized controlled trial consecutively enrolled 380 biopsy-naïve patients (CTSBx: n = 190, TPLBx: n = 190) with a single unilateral suspicious lesion on prostate MRI from June 2024 to November 2024. The noninferiority margin was -15%. All biopsies were undertaken transrectally through the cognitive fusion technique. The primary outcome was Grade Group (GG) ≥ 2 cancer (GG ≥ 2-PCa) detection rate. The GG ≥ 2-PCa (58% vs 58%, risk difference [RD]: 0.53% [95% CI: -9.4% to 11%]) and GG ≥ 3-PCa (30% vs 30%, RD: 0.53% [95% CI: -8.7% to 9.7%]) detection rates of TPLBx were noninferior to that of CTSBx (<i>P</i> < .001). There was no significant difference in PCa and GG1-PCa detection rates between the 2 groups (<i>P</i> > .050). The complication rate of TPLBx was significantly lower than that of CTSBx group (Clavien-Dindo scale ≥ 1: 62% vs 74%, <i>P</i> = .023), especially for bleeding-related complications (rectal bleeding: 34% vs 48%, <i>P</i> = .003; hematuria, 39% vs 56%, <i>P</i> < .001) and rectal pain (25% vs 34%, <i>P</i> = .018). TPLBx could significantly shorten the procedure time and saved the pathological cost (<i>P</i> < .001). For patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the noninferior diagnostic efficacy of clinically significant PCa and better safety than the CTSBx scheme. ClinicalTrials.gov Identifier: NCT06482658.