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    v: Generated Narrative: PublicationRecord 179621 version: 19; Last updated: 2025-10-13 12:34:35+0000 Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/PublicationRecord/179621 identifier: FEvIR Object Identifier/179621, https://pubmed.ncbi.nlm.nih.gov/26028518 title: 26028518 Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. status: Active author: Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: Computable Publishing LLC contact: support@computablepublishing.com description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide. UseContexts - Code Value[x] * Citation Classification Type: fevir-platform-use (FEvIR Platform Use) Medline Base copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/ approvalDate: 2015-09-28 lastReviewDate: 2024-08-05 classification type: Citation Source classifier: MEDLINE classification type: MEDLINE Citation Owner classifier: National Library of Medicine, Index Section currentState: Medline Citation Status of Medline, PubMed PublicationStatus of ppublish statusDate activity: PubMed Pubstatus of Received period: ?? --> 2015-04-15 statusDate activity: PubMed Pubstatus of Revised period: ?? --> 2015-05-06 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2015-05-08 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2015-06-02 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2015-06-02 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2015-09-29 06:00:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/26028518, https://doi.org/10.1016/S1470-2045(15)00011-X, pii/S1470-2045(15)00011-X relatedIdentifier: <a href="http://terminology.hl7.org/7.3.0/NamingSystem-ClinicalTrialsGov.html" title="RETIREMENT INFO:…
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    v: **BACKGROUND:** Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer. **METHODS:** We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration >20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2) and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731. **FINDINGS:** We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and…
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