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

Authors

Clarissa Julia Schmidt, Tim Reichert, Florian C Gaertner, Barbara Kreppel, Markus Essler, Julian A Luetkens, Ulrike Attenberger, Michael Anspach, Carsten-Henning Ohlmann, Stefan Hauser, Jörg Ellinger, Manuel Ritter, Philipp Krausewitz

Published in

World journal of urology. Volume 44. Issue 1. Sep 17, 2026. Epub Sep 17, 2026.

Abstract

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.
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.
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.
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.

PMID:
42752988
Bibliographic data and abstract were imported from PubMed on 18 Sep 2026.

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