Diagnostic Performance of Perineal MRI-US Fusion Prostate Biopsy: A Single-Center Prospective Cohort Analysis.

Background

Transperineal magnetic resonance (MRI)/ultrasound (US) fusion-guided prostate biopsy has emerged as a promising alternative to the transrectal approach by improving lesion targeting and reducing infectious complications. However, real-world data addressing factors that influence the detection of clinically significant prostate cancer (csPCa), including imaging characteristics and procedural experience, remain limited.

Objective

To evaluate the diagnostic performance, safety profile, and independent predictors of csPCa detection in patients who underwent transperineal MR/US fusion-guided prostate biopsy, with particular emphasis on PIRADS category, prostate-specific antigen (PSA) level, and procedural learning curve.

Methods

In this study, patient data were prospectively recorded in a routinely maintained institutional database, while the present analysis was conducted retrospectively. A total of 136 patients with clinical suspicion of prostate cancer-defined as elevated prostate-specific antigen (PSA), abnormal digital rectal examination, or PIRADS ≥3 on multiparametric MRI-underwent transperineal MR/US fusion-guided biopsy between January 2023 and October 2024.

Results

Prostate cancer was detected in 45.5% of patients, whereas csPCa was identified in 32.3%. The PIRADS category emerged as the strongest independent predictor of csPCa detection, with PIRADS-5 lesions showing a significantly greater likelihood of csPCa than PIRADS-3 lesions (OR 6.70, p = 0.006). The PSA level was also independently associated with csPCa detection (OR 1.06 per ng/mL increase, p = 0.033). Although csPCa detection rates increased across learning curve groups, procedural experience was not an independent predictor after adjustment. The procedure demonstrated a favorable safety profile, with a low rate of infectious and noninfectious complications despite minimal use of antibiotic prophylaxis. The multivariable model showed moderate explanatory power and acceptable overall classification accuracy.

Conclusions

Transperineal MR/US fusion-guided prostate biopsy provides reliable detection of clinically significant prostate cancer with a low complication rate and consistent performance across different stages of institutional experience. The PIRADS category and PSA level remain key determinants of csPCa detection, supporting the integration of MRI-based risk stratification into contemporary prostate cancer diagnostic methods.