Generated Narrative: Citation 179625 version: 18; Last updated: 2025-10-13 12:34:35+0000; Language: en Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/Citation/179625 identifier: FEvIR Object Identifier/179625, https://pubmed.ncbi.nlm.nih.gov/22502942 title: 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 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: 2012-12-07 lastReviewDate: 2022-03-10 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: ?? --> 2012-02-03 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2012-03-23 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2012-04-17 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2012-04-17 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2012-12-12 06:00:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/22502942, https://doi.org/10.1016/j.eururo.2012.03.053, pii/S0302-2838(12)00425-3 Titles - Type Text * Primary title Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial. Abstracts - Type Text Copyright * Primary human use BACKGROUND: Radiotherapy combined with androgen-deprivation therapy (ADT) is superior to radiotherapy alone in localised prostate cancer; however, data comparing ADT alone are somewhat limited. OBJECTIVE: To compare 3-yr ADT plus radiotherapy with ADT alone in locally advanced prostate cancer patients. DESIGN, SETTING, AND PARTICIPANTS: A multicentre randomised open controlled phase 3 trial in 264 histologically confirmed T3-4 or pT3N0M0 prostate cancer patients randomised from March 2000 to December 2003. INTERVENTION: ADT (11.25mg subcutaneous depot injection of leuprorelin every 3 mo for 3 yr) plus external-beam radiotherapy or ADT alone. Flutamide (750 g/d) was administered for 1 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary objective was 5 yr progression-free survival (PFS) according to clinical or biologic criteria, using the American Society for Therapeutic Radiology and Oncology (ASTRO) and the newer (Phoenix) definition (nadir plus 2 ng/ml), by intention to treat. Secondary objectives included time to locoregional recurrence and distant metastases, and overall and disease-specific survival. Our Analyses: intent-to-treat analysis, multivariate analyses using a Cox model with a 5% threshold from univariate analysis, and Kaplan-Meier estimates. RESULTS AND LIMITATIONS: ADT alone was administered to 130 patients and combined therapy to 133. With a median follow-up of 67 mo, 5-yr PFS was 60.9% for combined therapy versus 8.5% with ADT alone (ASTRO; p<0.0001), and 64.7% versus 15.4%, respectively, for Phoenix (p<0.0011). Locoregional progression was reported in 9.8% of combined-therapy patients versus 29.2% with ADT alone (p<0.0001) and metastatic progression in 3.0% versus 10.8%, respectively (p<0.018). Overall survival was 71.4% with combined therapy versus 71.5% with ADT alone; disease-specific survival was 93.2% versus 86.2%. Limitations included the relatively small population and a relatively short follow-up period. CONCLUSIONS: Combined therapy strongly favoured improved PFS, locoregional control, and metastasis-free survival. Longer follow-up is needed to assess the potential survival impact. Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. RelatesTos - Type Classifier Citation Target[x] * Has Comment In Comment Eur Urol. 2012 Aug;62(2):220-1; author reply 222-3. doi: 10.1016/j.eururo.2012.04.040. https://pubmed.ncbi.nlm.nih.gov/22552217/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1873-7560, ISOAbbreviation/Eur Urol, ISSN Linking/0302-2838, Medline Title Abbreviation/Eur Urol, NLM Unique ID/7512719 title: European urology publisherLocation: Switzerland citedMedium: Internet volume: 62 issue: 2 articleDate: 2012-08 pageString: 213-9 publicationForm citedMedium: Internet without issue articleDate: 2012-04-03 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/22502942/ webLocation classifier: DOI Based url: https://doi.org/10.1016/j.eururo.2012.03.053 classification type: Publishing Model classifier: Print Electronic classification type: Chemical classifier: Androgen Antagonists, Antineoplastic Agents, Hormonal, Flutamide, Prostate-Specific Antigen, Leuprolide classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Clinical Trial, Phase III, 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: Mottet N forenameInitials: N affiliation: Department of Urology, University Hospital, St. Etienne, France. nicolas.mottet@wanadoo.fr entry contributor: Peneau M forenameInitials: M entry contributor: Mazeron JJ forenameInitials: JJ entry contributor: Molinie V forenameInitials: V entry contributor: Richaud P forenameInitials: P Generated Narrative: Practitioner #contributor0 name: Nicolas Mottet Generated Narrative: Practitioner #contributor1 name: Michel Peneau Generated Narrative: Practitioner #contributor2 name: Jean-Jacques Mazeron Generated Narrative: Practitioner #contributor3 name: Vincent Molinie Generated Narrative: Practitioner #contributor4 name: Pierre Richaud Generated Narrative: ArtifactAssessment #meshHeading0 artifact: Citation 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial. content type: components (if present) include qualifier codings classifier: Adenocarcinoma freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: drug therapy Components - 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22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 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
Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial.
**BACKGROUND:** Radiotherapy combined with androgen-deprivation therapy (ADT) is superior to radiotherapy alone in localised prostate cancer; however, data comparing ADT alone are somewhat limited. **OBJECTIVE:** To compare 3-yr ADT plus radiotherapy with ADT alone in locally advanced prostate cancer patients. **DESIGN, SETTING, AND PARTICIPANTS:** A multicentre randomised open controlled phase 3 trial in 264 histologically confirmed T3-4 or pT3N0M0 prostate cancer patients randomised from March 2000 to December 2003. **INTERVENTION:** ADT (11.25mg subcutaneous depot injection of leuprorelin every 3 mo for 3 yr) plus external-beam radiotherapy or ADT alone. Flutamide (750 g/d) was administered for 1 mo. **OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:** The primary objective was 5 yr progression-free survival (PFS) according to clinical or biologic criteria, using the American Society for Therapeutic Radiology and Oncology (ASTRO) and the newer (Phoenix) definition (nadir plus 2 ng/ml), by intention to treat. Secondary objectives included time to locoregional recurrence and distant metastases, and overall and disease-specific survival. Our Analyses: intent-to-treat analysis, multivariate analyses using a Cox model with a 5% threshold from univariate analysis, and Kaplan-Meier estimates. **RESULTS AND LIMITATIONS:** ADT alone was administered to 130 patients and combined therapy to 133. With a median follow-up of 67 mo, 5-yr PFS was 60.9% for combined therapy versus 8.5% with ADT alone (ASTRO; p<0.0001), and 64.7% versus 15.4%, respectively, for Phoenix (p<0.0011). Locoregional progression was reported in 9.8% of combined-therapy patients versus 29.2% with ADT alone (p<0.0001) and metastatic progression in 3.0% versus 10.8%, respectively (p<0.018). Overall survival was 71.4% with combined therapy versus 71.5% with ADT alone; disease-specific survival was 93.2% versus 86.2%. Limitations included the relatively small population and a relatively short follow-up period. **CONCLUSIONS:** Combined therapy strongly favoured improved PFS, locoregional control, and metastasis-free survival. Longer follow-up is needed to assess the potential survival impact.
Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Classifier added by Computable Publishing LLC
Department of Urology, University Hospital, St. Etienne, France. nicolas.mottet@wanadoo.fr