Developing an individualised prostate biopsy algorithm in patients with PI-RADS ≥3 lesions: a prospective multicentre cohort study protocol in China

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INTRODUCTION: Prostate biopsy remains the gold standard for prostate cancer diagnosis. Current guidelines recommend combining MRI-targeted biopsy with systematic biopsy (SB) to maximise detection of clinically significant prostate cancer (csPCa), but high-level evidence for individualised strategies remains limited, particularly for Prostate Imaging-Reporting and Data System (PI-RADS) ≥3 lesions. This study aims to determine the optimal biopsy approach for these patients. METHODS AND ANALYSIS: This prospective, multicentre cohort study will enrol 300 treatment-naive patients with PI-RADS ≥3 lesions across six centres. Patients with PI-RADS=3 will choose between active surveillance (total prostate-specific antigen and multiparametric MRI monitoring) or immediate 12-core SB. Patients with PI-RADS ≥4 will undergo combined biopsy with comparison of 12-core, 6-core and targeted-only strategies. The primary endpoint is csPCa detection rate (International Society of Urological Pathology grade ≥2). Secondary endpoints include any prostate cancer detection, false-negative rates and complications. Analysis includes non-inferiority testing, logistic regression and receiver operating characteristic curve analysis. ETHICS AND DISSEMINATION: The study has been approved by the institutional review board at Shenzhen Hospital of Southern Medical University (No. NYSZYYEC2025K150R001) with local approval at each site. All participants will provide written informed consent. Results will be submitted to peer-reviewed journals and presented at international urology conferences. TRIAL REGISTRATION NUMBER: ChiCTR2500114101.

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