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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the prospective, multicenter DEPROMP trial, 230 biopsy-na\u00efve 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\u2013Dindo 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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\u2013Dindo 1\u20132). 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,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001), while AEs were not.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00345-026-06767-6","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T11:51:15Z","timestamp":1789645875000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and patient-reported outcomes of multimodal PSMA PET\/MRI-guided prostate biopsy: results from the prospective multicenter DEPROMP trial"],"prefix":"10.1007","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-1651-1595","authenticated-orcid":false,"given":"Clarissa Julia","family":"Schmidt","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim","family":"Reichert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6298-0145","authenticated-orcid":false,"given":"Florian C.","family":"Gaertner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-0097-2296","authenticated-orcid":false,"given":"Barbara","family":"Kreppel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-1884-1944","authenticated-orcid":false,"given":"Markus","family":"Essler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7715-4636","authenticated-orcid":false,"given":"Julian A.","family":"Luetkens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8123-5447","authenticated-orcid":false,"given":"Ulrike","family":"Attenberger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Anspach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten-Henning","family":"Ohlmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9171-4225","authenticated-orcid":false,"given":"Stefan","family":"Hauser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7526-0857","authenticated-orcid":false,"given":"J\u00f6rg","family":"Ellinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Ritter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8213-9975","authenticated-orcid":false,"given":"Philipp","family":"Krausewitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,17]]},"reference":[{"issue":"8","key":"6767_CR1","doi-asserted-by":"publisher","first-page":"e198427","DOI":"10.1001\/jamanetworkopen.2019.8427","volume":"2","author":"MMC Elwenspoek","year":"2019","unstructured":"Elwenspoek MMC, Sheppard AL, McInnes MDF et al (2019) Comparison of multiparametric magnetic resonance imaging and targeted biopsy with systematic biopsy alone for the diagnosis of prostate cancer: a systematic review and meta-analysis. 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The procedures used in this study adhere to the tenets of the Declaration of Helsinki. Written, informed consent to participate was obtained from all participants before screening and baseline assessments. The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":2,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Patients signed informed consent regarding publishing their data and photographs.","order":3,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"During the preparation of this work, the author, Clarissa Julia Schmidt, used chat.openai.com to check grammar and spelling, as she is a non-native speaker. After using this tool\/service, the author reviewed and edited the content as needed and takes full responsibility for the content of the publication.","order":5,"name":"Ethics","label":"Generative AI and AI-assisted technologies in the writing process","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"669"}}