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: This entry was incorrectly added as a code system record, however, ClinicalTrials.gov is an identifier system. That entry should be referenced instead at [https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html](https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html).#xD;#xA;#xD;#xA;The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed [ClinicalTrials.gov](http://clinicaltrials.gov) to provide patients, family members, and members of the public current information about clinical research studies. [ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.#xD;#xA;#xD;#xA;[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. You should check [ClinicalTrials.gov](http://clinicaltrials.gov) frequently for updated information.#xD;#xA;#xD;#xA;More information about ClinicalTrials.gov can be found [here](https://clinicaltrials.gov/about-site/about-ctg).">ClinicalTrials.gov/NCT00055731 Titles - Type Language Text * Primary title English 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. Abstracts - Type Text Copyright * Primary human use 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 had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths. INTERPRETATION: Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival. FUNDING: Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer. Copyright © 2015 Elsevier Ltd. All rights reserved. relatesTo type: Has Comment In classifier: Comment citation: Lancet Oncol. 2015 Jul;16(7):741-2. doi: 10.1016/S1470-2045(15)00012-1. target: https://pubmed.ncbi.nlm.nih.gov/26028517/ relatesTo type: Has Comment In classifier: Comment citation: Nat Rev Urol. 2015 Jul;12(7):358. doi: 10.1038/nrurol.2015.146. target: https://pubmed.ncbi.nlm.nih.gov/26077993/ relatesTo type: Has Comment In classifier: Comment citation: Eur Urol. 2015 Dec;68(6):1098-9. doi: 10.1016/j.eururo.2015.08.047. target: https://pubmed.ncbi.nlm.nih.gov/26545569/ relatesTo type: Has Comment In classifier: Comment citation: Nat Rev Clin Oncol. 2015 Dec;12(12):687-8. doi: 10.1038/nrclinonc.2015.192. target: https://pubmed.ncbi.nlm.nih.gov/26552950/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1474-5488, ISOAbbreviation/Lancet Oncol, ISSN Linking/1470-2045, Medline Title Abbreviation/Lancet Oncol, NLM Unique ID/100957246 title: The Lancet. Oncology publisherLocation: England citedMedium: Internet volume: 16 issue: 7 articleDate: 2015-07 pageString: 787-94 publicationForm citedMedium: Internet without issue articleDate: 2015-05-28 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/26028518/ webLocation classifier: DOI Based url: https://doi.org/10.1016/S1470-2045(15)00011-X classification type: Publishing Model classifier: Print Electronic classification type: Chemical classifier: Androgen Antagonists, Taxoids, Docetaxel, Estramustine, Prostate-Specific Antigen classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't classification type: Knowledge Artifact Type classifier: Journal Article artifactAssessment: Classifier added by Computable Publishing LLC classification type: Citation subset classifier: IM contributorship complete: true entry contributor: Fizazi K forenameInitials: K affiliation: Institut Gustave Roussy, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr. entry contributor: Faivre L forenameInitials: L affiliation: Institut Gustave Roussy, Villejuif, France. entry contributor: Lesaunier F forenameInitials: F affiliation: Centre François Baclesse, Caen, France. entry contributor: Delva R forenameInitials: R affiliation: Institut de Cancérologie de l'Ouest, Angers, France. entry contributor: Gravis G forenameInitials: G affiliation: Institut Paoli Calmettes, Marseille, France. entry contributor: Rolland F forenameInitials: F affiliation: Institut de Cancérologie de l'Ouest, Nantes, France. entry contributor: Priou F forenameInitials: F affiliation: Centre Hospitalier Départemental, La Roche-sur-Yon, France. entry contributor: Ferrero JM forenameInitials: JM affiliation: Centre Antoine Lacassagne, Nice, France. entry contributor: Houede N forenameInitials: N affiliation: Centre Hospitalier de Nimes, Nimes, France. entry contributor: Mourey L forenameInitials: L affiliation: Institut Claudius Regaud, Toulouse, France. entry contributor: Theodore C forenameInitials: C affiliation: Hôpital Foch, Paris, France. entry contributor: Krakowski I forenameInitials: I affiliation: Centre Alexis Vautrin, Nancy, France. entry contributor: Berdah JF forenameInitials: JF affiliation: Clinique Sainte-Marguerite, Hyères, France. entry contributor: Baciuchka M forenameInitials: M affiliation: Centre Hospitalier La Timone, Marseille, France. entry contributor: Laguerre B forenameInitials: B affiliation: Centre Eugène Marquis, Rennes, France. entry contributor: Fléchon A forenameInitials: A affiliation: Centre Léon Bérard, Lyon, France. entry contributor: Ravaud A forenameInitials: A affiliation: Hôpital Saint-André, Bordeaux, France. entry contributor: Cojean-Zelek I forenameInitials: I affiliation: Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France. entry contributor: Oudard S forenameInitials: S affiliation: Hôpital Européen Georges Pompidou, Paris, France. entry contributor: Labourey JL forenameInitials: JL affiliation: CHU Dupuytren, Limoges, France. entry contributor: Chinet-Charrot P forenameInitials: P affiliation: Centre Henri Becquerel, Rouen, France. entry contributor: Legouffe E forenameInitials: E affiliation: Centre Médical Oncogard, Nimes, France. entry contributor: Lagrange JL forenameInitials: JL affiliation: Hôpital Henri-Mondor, Créteil, France. entry contributor: Linassier C forenameInitials: C affiliation: Hôpital Bretonneau, Tours, France. entry contributor: Deplanque G forenameInitials: G affiliation: Hôpital Saint-Joseph, Paris, France. entry contributor: Beuzeboc P forenameInitials: P affiliation: Institut Curie, Paris, France. entry contributor: Davin JL forenameInitials: JL affiliation: Clinique Sainte-Catherine, Avignon, France. entry contributor: Martin AL forenameInitials: AL affiliation: Unicancer, Paris, France. entry contributor: Habibian M forenameInitials: M affiliation: Unicancer, Paris, France. entry contributor: Laplanche A forenameInitials: A affiliation: Institut Gustave Roussy, Villejuif, France. entry contributor: Culine S forenameInitials: S affiliation: Hôpital Saint-Louis, Paris, France. Generated Narrative: Practitioner #contributor0 name: Karim Fizazi Generated Narrative: Practitioner #contributor1 name: Laura Faivre Generated Narrative: Practitioner #contributor2 name: François Lesaunier Generated Narrative: Practitioner #contributor3 name: Remy Delva Generated Narrative: Practitioner #contributor4 name: Gwenaëlle Gravis Generated Narrative: Practitioner #contributor5 name: Frédéric Rolland Generated Narrative: Practitioner #contributor6 name: Frank Priou Generated Narrative: Practitioner #contributor7 name: Jean-Marc Ferrero Generated Narrative: Practitioner #contributor8 name: Nadine Houede Generated Narrative: Practitioner #contributor9 name: Loïc Mourey Generated Narrative: Practitioner #contributor10 name: Christine Theodore Generated Narrative: Practitioner #contributor11 name: Ivan Krakowski Generated Narrative: Practitioner #contributor12 name: Jean-François Berdah Generated Narrative: Practitioner #contributor13 name: Marjorie Baciuchka Generated Narrative: Practitioner #contributor14 name: Brigitte Laguerre Generated Narrative: Practitioner #contributor15 name: Aude Fléchon Generated Narrative: Practitioner #contributor16 name: Alain Ravaud Generated Narrative: Practitioner #contributor17 name: Isabelle Cojean-Zelek Generated Narrative: Practitioner #contributor18 name: Stéphane Oudard Generated Narrative: Practitioner #contributor19 name: Jean-Luc Labourey Generated Narrative: Practitioner #contributor20 name: Paule Chinet-Charrot Generated Narrative: Practitioner #contributor21 name: Eric Legouffe Generated Narrative: Practitioner #contributor22 name: Jean-Léon Lagrange Generated Narrative: Practitioner #contributor23 name: Claude Linassier Generated Narrative: Practitioner #contributor24 name: Gaël Deplanque Generated Narrative: Practitioner #contributor25 name: Philippe Beuzeboc Generated Narrative: Practitioner #contributor26 name: Jean-Louis Davin Generated Narrative: Practitioner #contributor27 name: Anne-Laure Martin Generated Narrative: Practitioner #contributor28 name: Muriel Habibian Generated Narrative: Practitioner #contributor29 name: Agnès Laplanche Generated Narrative: Practitioner #contributor30 name: Stéphane Culine Generated Narrative: ArtifactAssessment #meshHeading0 artifact: PublicationRecord 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. content type: components (if present) include qualifier codings classifier: Aged freeToShare: true Components - 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Antineoplastic Combined Chemotherapy Protocols
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.
Computable Publishing®: MEDLINE-to-FEvIR Converter
This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
National Library of Medicine, Index Section
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.
**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 had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths. **INTERPRETATION:** Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival. **FUNDING:** Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer.
Copyright © 2015 Elsevier Ltd. All rights reserved.
Classifier added by Computable Publishing LLC
Institut Gustave Roussy, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.
Institut Gustave Roussy, Villejuif, France.
Institut de Cancérologie de l'Ouest, Angers, France.
Institut Paoli Calmettes, Marseille, France.
Institut de Cancérologie de l'Ouest, Nantes, France.
Centre Hospitalier Départemental, La Roche-sur-Yon, France.
Centre Antoine Lacassagne, Nice, France.
Centre Hospitalier de Nimes, Nimes, France.
Institut Claudius Regaud, Toulouse, France.
Clinique Sainte-Marguerite, Hyères, France.
Centre Hospitalier La Timone, Marseille, France.
Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.
Hôpital Européen Georges Pompidou, Paris, France.
Clinique Sainte-Catherine, Avignon, France.