Efficacy and Safety Evaluation of Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial
The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including perilesional/regional systematic biopsy (PB/RSB) and combination of systematic biopsy and targeted biopsy (TB+SB). The main questions it aims to answer are: Does PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB/RSB and combination of TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life. Participants will: Receive PB/RSB or TB+SB.
• The age of the patient is between 45 and 85.
• No previous biopsy.
• Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of \> 3.
• Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15.
• The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.
• Patients with complete clinical information.