Enhanced detection of clinically significant prostate cancer in targeted and non-targeted regions using BiopSee® MRI/ultrasound fusion biopsy.

Objectives: This study evaluated the cancer detection profile of magnetic resonance imaging/transrectal ultrasound fusion-guided biopsies (fusion biopsy) using the BiopSee^® system in patients assessed with the Prostate Imaging Reporting and Data System (PI-RADS) version 2.1, focusing on clinically significant prostate cancer (csPCa) detection in regions of interest (ROI) and non-ROI areas.

Methods: We retrospectively analyzed 59 patients who underwent fusion biopsy between February and November 2024. Detection rates of csPCa (grade group ≥ 2) were compared between the ROI and non-ROI regions, and clinical and biopsy characteristics were compared between patients with and without csPCa. Univariate logistic regression analysis was performed to identify predictors of csPCa.

Results: The median patient age was 74 years, with a median prostate-specific antigen (PSA) level of 8.93 ng/mL. The csPCa detection rate was significantly higher in the ROI than in the non-ROI regions (61% vs. 44%, P = 0.012). Across the cohort, PI-RADS 4 and 5 lesions were more common than PI-RADS 3 lesions. A higher PI-RADS score (4 or 5) was identified as a significant predictor of csPCa detection (odds ratio 5.14, P = 0.034), whereas age, PSA, number of ROIs, and biopsy core numbers were not significant predictors.

Conclusions: Fusion biopsy using the BiopSee^® system achieved a high csPCa detection rate in targeted ROIs, especially for PI-RADS 4 and 5 lesions, while also highlighting the importance of combining systematic biopsy with targeted approaches because of the substantial proportion of csPCa detected in non-ROI regions.