Evaluation of Transrectal Perilesional Biopsy in Diagnosis of Prostate Cancer

Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the combined biopsy approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, especially for transrectal prostate biopsy, and there is still a lack of high-quality, prospective evidence for the transrectal PB/RSB schemes. Thus, this single-center randomized controlled trial (RCT) aims to evaluate the efficacy and safety of transrectal PB/RSB schemes and the routine transrectal TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes. The main questions it aims to answer are: Does transrectal PB/RSB promote the accurate diagnosis of csPCa? What is the value of PB/RSB in improving the safety of transrectal prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of transrectal PB/RSB and combination of transrectal TB+SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from July 2024 to June 2025. Participants were randomly allocated to PB/RSB group and TB+SB group. Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of transrectal TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life. Participants will: Receive transrectal PB/RSB or TB+SB.