Optimized Biopsy Strategy for Transition Zone Prostate Cancer With Enhanced Perilesional Sampling: A Retrospective Analysis and Clinical Trial Validation.

Purpose: Prostate biopsy (PBx) is crucial for diagnosing prostate cancer (PCa). This study aims to identify potential underdiagnosis of transition zone (TZ) PCa compared with peripheral zone (PZ) tumors and validate a novel PBx strategy to improve TZ tumor detection.

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 after 8^PZ + 4^TZ + X transperineal transrectal ultrasound-magnetic resonance imaging-fusion PBx between 2018 and 2021. The clinical trial investigated biopsy efficacy in 400 patients who underwent either modified 8^PZ + 10^TZ + X PBx for the TZ lesion or 8^PZ + 4^TZ + X PBx after block random assignment between 2022 and 2023 at our center.

Results: Retrospective analysis reveals identical TZ clinically significant prostate cancer (csPCa) detection rates for 8^PZ + 4^TZ + X and 4^TZ + X PBx, both of which were insufficient for detecting TZ csPCa compared with PZ tumors. Based on these findings, 8^PZ + 10^TZ + X PBx was constructed. In the trial, the 10^TZ + X and 8^PZ + 10^TZ + X PBx demonstrated identical TZ csPCa detection rates and biopsy positivity rate, outperforming the 4^TZ + X and 8^PZ + 4^TZ + X PBx without increasing complications. The self-controlled comparison showed equivalent results for 8^TZ + X and 8^PZ + 10^TZ + X PBx.

Conclusion: Our study found that PZ biopsies offer no additional benefit for TZ lesion tumors, and increasing the number of cores in the TZ region can compensate for the current limitations of TZ biopsies. These findings provide potential avenues for optimizing biopsy strategies for TZ lesions.