Generated Narrative: Citation 179625 version: 18; Last updated: 2025-10-13 12:34:35+0000 Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: Citation 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial. identifier: FEvIR Object Identifier/179625, https://pubmed.ncbi.nlm.nih.gov/22502942, <a href="http://terminology.hl7.org/7.0.1/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt #xD;#xA;#xD;#xA;This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: #xD;#xA;#xD;#xA;Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.#xD;#xA;#xD;#xA;This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.5 version: 1.0.0-ballot3 title: 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial. status: Active date: 2026-01-08 11:24:31+0000 author: Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: HL7 International / Clinical Decision Support contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss 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 jurisdiction: World 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 * Has Comment In Comment Eur Urol. 2012 Aug;62(2):220-1; author reply 222-3. doi: 10.1016/j.eururo.2012.04.040. 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
HL7 International / Clinical Decision Support
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