Trial reportWorld journal of urology2026
Safety and patient-reported outcomes of multimodal PSMA PET/MRI-guided prostate biopsy: results from the prospective multicenter DEPROMP trial.
Trial report in World journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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13 authors.
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Abstract
purposeMultiparametric 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.
methodsIn 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.
resultsAEs 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.
conclusionMultimodal 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.
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