Increasing the Number of Biopsy Cores Around Prostate Cancer Targeted Lesions in the Transition Zone to Improve Biopsy Accuracy: A Combined Retrospective and Prospective Study

Background Prostate biopsy (PBx) plays a pivotal role in diagnosing prostate cancer (PCa). However, the prostate biopsy results for transition zone (TZ) tumors were found to be less accurate than those for peripheral zone tumors. The objective of this study was to identify potential under-detection of TZ PCa and to validate a new biopsy template that increases the number of cores around TZ targeted lesions to improve biopsy accuracy for TZ tumors. Materials and Methods This study comprised two components: a retrospective analysis and a randomized clinical trial. The retrospective study included 217 patients who underwent radical prostatectomy following "12 + X" template transperineal transrectal ultrasound-magnetic resonance imaging-fusion PBx between 2018 and 2021 at our institution. The clinical trial investigated biopsy efficacy for clinically significant PCa (csPCa) in 400 patients who underwent either modified "18 + X" template PBx for TZ lesion or "12 + X" template PBx following systematic sampling between 2022 and 2023 at our center. Results The retrospective analysis revealed that the "12 + X" template, comprising 4 cores in TZ, failed to adequately detect csPCa in the TZ. “18 + X” template was constructed based on the results of retrospective analysis. Conversely, in the prospective trial, the "18 + X" template, with 10 cores in TZ, outperformed the "12 + X" template in detecting TZ csPCa without a corresponding increase in complications. Building upon the result, "18 + X" template was improved to the "New 12" and "New 12 + X" templates, with 8 cores in TZ and 4 cores in peripheral zone, while maintaining the same csPCa detection rate for TZ patients. Conclusions Our study demonstrated that increasing the number of biopsy cores around targeted lesions in the TZ improves biopsy accuracy and reduces the number of biopsies in non-targeted regions without compromising overall accuracy. The new template offers a promising approach to improve biopsy for patients with TZ lesions. Trial Registration: This study was approved by Clinical trial registration in China Clinical Trial Registry (ChiCTR2200056386). Registered 04 February 2022, https://www.chictr.org.cn