{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:55:10Z","timestamp":1793332510185,"version":"4.5.0"},"reference-count":24,"publisher":"American Medical Association (AMA)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2025,12,1]]},"abstract":"<jats:sec>\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Prostate-specific membrane antigen positron emission tomography (PSMA-PET) offers superior accuracy in detecting prostate cancer lesions leading to intensified radiotherapy (RT), but its impact on patient outcomes is still undefined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate whether intensification of salvage RT (SRT) after radical prostatectomy (RP) guided by PSMA-PET (PSMAiSRT) is associated with improved failure-free survival (FFS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>PSMAiSRT was a stratified cohort within a larger PSMA-guided intensification of radiotherapy (PSMAgRT) trial, a phase 2, two-center, registry-based randomized clinical trial. Patients with biochemical recurrence following RP who were eligible for standard-of-care (SOC) SRT from May 2018 to February 2021, were eligible for randomization in the PSMAiSRT stratum. A total of 130 patients were randomized, with 2 who did not proceed to radiotherapy (RT). The cutoff date for the primary analysis was October 26, 2023<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Patients were randomized in a 1:1 ratio to receive either SOC SRT to the prostate bed, with or without elective pelvic RT, with or without adjuvant hormonal therapy (HT), or PSMA-PET\/CT-guided SRT, intensified to detected sites of disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome and measures<\/jats:title>\n                    <jats:p>The primary end point was FFS, defined as PSA progression (PSA nadir &amp;amp;gt;0.2 ng\/mL), radiological progression, next-line therapy initiation, or death.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 128 patients (median [IQR] age, 71 [64-74] years), median (range) PSA at enrollment was 0.3 (0.1-3.0) ng\/mL. In the PSMAiSRT group, 33 of 64 patients (52%) received intensified SRT; with addition of pelvic RT (n\u2009=\u200916 [25%]), metastasis-directed RT (n\u2009=\u20092 [3%]), lymph node boost (n\u2009=\u200919 [30%]), or prostate bed boost (n\u2009=\u200915). Adjuvant hormone therapy was equally prevalent in both arms (55 [86%] control vs 54 [84%] PSMAiSRT). At a median (range) follow-up of 37 (7-60) months, PSMAiSRT improved FFS (hazard ratio [HR], 0.50; 95% CI, 0.27-0.94;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.04) and eugonadal FFS (HR, 0.45; 95% CI, 0.21-0.96;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.03), with its greatest benefit in the subgroup with PSA of 0.3 ng\/mL or more (HR, 0.17; 95% CI, 0.04-0.79;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.01). Fewer next-line treatment events occurred in the PSMAiSRT arm (4 vs 12; HR, 0.32; 95% CI, 0.11-1.02;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.04). There were no significant differences in toxic effects or quality of life between arms.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Relevance<\/jats:title>\n                    <jats:p>This phase 2 trial demonstrated an isotoxic improvement in cancer control with PSMA-PET-guided intensification of SRT after RP. Confirmatory evidence is awaited from a subsequently accrued phase 3 trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT03525288?cond=NCT03525288&amp;amp;amp;rank=1\">NCT03525288<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamaoncol.2025.3746","type":"journal-article","created":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T15:31:23Z","timestamp":1759419083000},"page":"1431","source":"Crossref","is-referenced-by-count":29,"title":["Prostate-Specific Membrane Antigen PET-Guided Intensification of Salvage Radiotherapy After Radical 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