Safety and patient-reported outcomes of multimodal PSMA PET/MRI-guided prostate biopsy: results from the prospective multicenter DEPROMP trial.

PURPOSE: Multiparametric MRI and PSMA PET/CT have improved prostate cancer detection and targeting. While MRI-guided biopsy is well established, data on the procedural safety and patient-reported outcomes (PROs) of multimodal MRI- and PSMA-guided biopsy remain limited. We prospectively evaluated adverse events (AEs) and PROs following multimodal prostate biopsy. METHODS: In the prospective, multicenter DEPROMP trial, 230 biopsy-naïve men with suspected prostate cancer underwent systematic, MRI-targeted, and PSMA PET/CT-targeted transrectal biopsy. AEs were assessed longitudinally and graded using the Clavien-Dindo classification. Associations between biopsy core number and AEs were analyzed. PROs were evaluated at 6 months using structured interviews. Multivariable analyses assessed predictors of PROs. RESULTS: AEs were infrequent post-biopsy (94.8% without symptoms) and declined over time, with 87.4% symptom-free at 6 months. Most AEs were low-grade (Clavien-Dindo 1-2). Infectious complications were rare. At 6 months, 42.6% of patients reported unchanged and 22.1% improved quality of life, whereas 29.5% reported deterioration. Quality-of-life changes were more frequently attributed to cancer diagnosis (49.6%) than to biopsy-related AEs (1.7%). Cancer diagnosis was independently associated with worse quality of life (OR 12.94, p < 0.001), while AEs were not. CONCLUSION: Multimodal MRI- and PSMA-guided prostate biopsy was associated with low morbidity, high patient acceptance, and favorable PROs. Quality-of-life changes were more frequently attributed to cancer diagnosis than to biopsy-related AEs. These findings provide patient-centered evidence supporting contemporary image-guided prostate cancer diagnostic pathways and highlight the importance of addressing psychological burden during patient counseling.