Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis

Prostate biopsy usually combines magnetic resonance imaging/ultrasound (MRI/US) cognitivefusion targeted biopsy with systematic biopsy. Standard bilateral systematic biopsyrequires sampling from both sides of the prostate and may increase the number of biopsycores, procedural discomfort, procedure time, pathological workload, and biopsy‐relatedcomplications.This prospective, multicenter, open‐label, randomized noninferiority trial will enroll454 biopsy‐naive men with suspected prostate cancer, a unilateral prostate MRI lesionwith a highest PI‐RADS score of 4 or 5, and prostate‐specific antigen levels of 20 ng/mLor lower. Participants will be randomly assigned in a 1:1 ratio to receive transperinealMRI/US cognitive fusion targeted biopsy combined with either a 6‐core ipsilateralsystematic biopsy or a standard 12‐core bilateral systematic biopsy.The primary objective is to determine whether the ipsilateral systematic biopsy strategyis noninferior to the bilateral systematic biopsy strategy for detecting clinicallysignificant prostate cancer, defined as International Society of Urological PathologyGrade Group 2 or higher. The study will also compare overall prostate cancer detection,biopsy core numbers, pain and discomfort, procedure time, pathological workload andcosts, urinary symptoms, quality of life, and biopsy‐related adverse events andcomplications through 30 days after biopsy.