{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T14:30:19Z","timestamp":1772721019470,"version":"3.50.1"},"reference-count":21,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T00:00:00Z","timestamp":1760054400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background and Objective<\/jats:title>\n                    <jats:p>Prostate cancer (PCa) presents with substantial biological heterogeneity and variable clinical outcomes. While genomic alterations in high\u2010risk and locally advanced cases may signal early progression or micrometastatic disease, their clinical finding and utility remains underexplored. This study aims to apply a comprehensive cancer genome profiling through next\u2010generation sequencing (NGS) to identify actionable mutations predictive of disease progression in non\u2010metastatic PCa.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design<\/jats:title>\n                    <jats:p>\n                      This single\u2010centre, prospective observational cohort study (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      : NCT06875297) is designed to recruit patients with high\u2010risk or locally advanced PCa undergoing radical prostatectomy (RP); a complementary arm of low\u2010risk patients managed by either active surveillance or RP are considered as well. Participants are enrolled from the Fondazione Policlinico Universitario A. Gemelli IRCCS.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Endpoints<\/jats:title>\n                    <jats:p>The primary endpoint is to detect Association for Molecular Pathology (AMP)\u2010American Society of Clinical Oncology [ASCO]\u2010College of American Pathologists [CAP] Tier I\u2013II genomic alterations associated with biochemical recurrence or progression in high\u2010risk and locally advanced PCa. Secondary endpoints include genomic alterations relevant to time to radiographic progression and castration resistance; for the low\u2010risk subset, upstage and\/or upgrade are considered as actionable endpoints to be predicted through NGS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Funding and Ethics and Trial Registration<\/jats:title>\n                    <jats:p>\n                      The study is non\u2010profit, ethically approved (Lazio Area 3, identifier: 7618), and registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      (NCT06875297).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.70019","type":"journal-article","created":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T11:39:23Z","timestamp":1760096363000},"page":"1022-1027","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A novel comprehensive cancer genome profiling for non\u2010metastatic prostate cancer: study protocol with\n                    <scp>FPG500<\/scp>\n                    to detect actionable alterations representative of progressive disease"],"prefix":"10.1111","volume":"136","author":[{"given":"Maria Chiara","family":"Sighinolfi","sequence":"first","affiliation":[{"name":"Department of Urology Fondazione Policlinico Universitario A. 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