{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T11:16:55Z","timestamp":1780053415537,"version":"3.54.0"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"26","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2021,9,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p>Although docetaxel is not recommended when managing men with unfavorable-risk prostate cancer (PC) given negative or inconclusive results from previous randomized trials, unstudied benefits may exist.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Between September 21, 2005, and January 13, 2015, we randomly assigned 350 men 1:1 with T1c-4N0M0 unfavorable-risk PC to receive radiation therapy (RT) and androgen deprivation therapy (ADT) plus docetaxel (60 mg\/m<jats:sup>2<\/jats:sup>once every 3 weeks for three cycles before RT and 20 mg\/m<jats:sup>2<\/jats:sup>once weekly during RT) versus ADT + RT. We evaluated the treatment effect of adding docetaxel to ADT + RT on the primary end point of overall survival (OS) and the incidence of RT-induced cancers and explored whether the impact of the treatment effect on OS differed within prostate-specific antigen (PSA) subgroups (&lt; 4, &gt; 20 v 4-20 ng\/mL) using the interaction test for heterogeneity adjusted for age and PC prognostic factors.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>After a median follow-up of 10.2 years, 89 men died (25.43%); of these, 42 from PC (47.19%). Although OS was not significantly increased in the docetaxel arm (the restricted mean survival time over 10 years was 9.11 v 8.82 years; P = .22), significantly fewer RT-induced cancers were observed (10-year estimates: 0.61% v 4.90%; age-adjusted hazard ratio of 0.13; 95% CI, 0.02 to 0.97; P = .046). The treatment effect of adding docetaxel to ADT + RT on OS significantly differed in men with a PSA &lt; 4 ng\/mL versus 4-20 ng\/mL (adjusted hazard ratio: 0.27 and 1.51, respectively) because of less PC-specific mortality on the docetaxel arm (0.00% v 28.57%) among men with PSA &lt; 4 ng\/mL.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>Adding docetaxel to ADT + RT did not prolong OS in men with unfavorable-risk PC, but decreased RT-induced cancer incidence, and may prolong OS in the subgroup of men with a PSA &lt; 4 ng\/mL by reducing PC-specific mortality.<\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.21.00596","type":"journal-article","created":{"date-parts":[[2021,7,1]],"date-time":"2021-07-01T20:01:25Z","timestamp":1625169685000},"page":"2938-2947","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":24,"title":["Radiation and Androgen Deprivation Therapy With or Without Docetaxel in the Management of Nonmetastatic Unfavorable-Risk Prostate Cancer: A Prospective Randomized Trial"],"prefix":"10.1200","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4084-9944","authenticated-orcid":false,"given":"Anthony V.","family":"D'Amico","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5995-8000","authenticated-orcid":false,"given":"Wanling","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Data Sciences, Dana Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"McMahon","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marian","family":"Loffredo","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shana","family":"Medeiros","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Joseph","sequence":"additional","affiliation":[{"name":"University of Western Australia, Nedlands, WA, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jim","family":"Denham","sequence":"additional","affiliation":[{"name":"Calvary Mater New Castle, Waratah, NSW, 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