Generated Narrative: Citation 179627 version: 21; Last updated: 2025-10-13 12:34:35+0000; Language: en Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/Citation/179627 identifier: FEvIR Object Identifier/179627, https://pubmed.ncbi.nlm.nih.gov/19091394 title: 19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III 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: 2009-02-05 lastReviewDate: 2022-03-30 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 Entrez period: ?? --> 2008-12-19 09:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2008-12-19 09:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2009-02-06 09:00:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/19091394, https://doi.org/10.1016/S0140-6736(08)61815-2, pii/S0140-6736(08)61815-2 relatedIdentifier: ISRCTN01534787 Titles - Type Text * Primary title Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Abstracts - Type Text * Primary human use BACKGROUND: Several studies have shown the efficacy of endocrine therapy in combination with radiotherapy in high-risk prostate cancer. To assess the effect of radiotherapy, we did an open phase III study comparing endocrine therapy with and without local radiotherapy, followed by castration on progression. METHODS: This randomised trial included men from 47 centres in Norway, Sweden, and Denmark. Between February, 1996, and December, 2002, 875 patients with locally advanced prostate cancer (T3; 78%; PSA<70; N0; M0) were centrally randomly assigned by computer to endocrine treatment alone (3 months of total androgen blockade followed by continuous endocrine treatment using flutamide; 439 patients), or to the same endocrine treatment combined with radiotherapy (436 patients). The primary endpoint was prostate-cancer-specific survival, and analysis was by intention to treat. This study is registered as an international standard randomised controlled trial, number ISRCTN01534787. FINDINGS: After a median follow-up of 7.6 years, 79 men in the endocrine alone group and 37 men in the endocrine plus radiotherapy group had died of prostate cancer. The cumulative incidence at 10 years for prostate-cancer-specific mortality was 23.9% in the endocrine alone group and 11.9% in the endocrine plus radiotherapy group (difference 12.0%, 95% CI 4.9-19.1%), for a relative risk of 0.44 (0.30-0.66). At 10 years, the cumulative incidence for overall mortality was 39.4% in the endocrine alone group and 29.6% in the endocrine plus radiotherapy group (difference 9.8%, 0.8-18.8%), for a relative risk of 0.68 (0.52-0.89). Cumulative incidence at 10 years for PSA recurrence was substantially higher in men in the endocrine-alone group (74.7%vs 25.9%, p<0.0001; HR 0.16; 0.12-0.20). After 5 years, urinary, rectal, and sexual problems were slightly more frequent in the endocrine plus radiotherapy group. INTERPRETATION: In patients with locally advanced or high-risk local prostate cancer, addition of local radiotherapy to endocrine treatment halved the 10-year prostate-cancer-specific mortality, and substantially decreased overall mortality with fully acceptable risk of side-effects compared with endocrine treatment alone. In the light of these data, endocrine treatment plus radiotherapy should be the new standard. relatesTo type: Correction In classifier: Published Erratum citation: Lancet. 2009 Apr 4;373(9670):1174 relatesTo type: Has Comment In classifier: Comment citation: Lancet. 2009 Jan 24;373(9660):274-6. doi: 10.1016/S0140-6736(08)61816-4. target: https://pubmed.ncbi.nlm.nih.gov/19091392/ relatesTo type: Has Comment In classifier: Comment citation: Nat Rev Urol. 2009 May;6(5):250-1. doi: 10.1038/nrurol.2009.56. target: https://pubmed.ncbi.nlm.nih.gov/19424171/ relatesTo type: Has Comment In classifier: Comment citation: Ann Intern Med. 2009 Jun 16;150(12):JC6-6. doi: 10.7326/0003-4819-150-12-200906160-02006. target: https://pubmed.ncbi.nlm.nih.gov/19528551/ relatesTo type: Has Comment In classifier: Comment citation: Eur Urol. 2009 May;55(5):1240. doi: 10.1016/j.eururo.2009.01.059. target: https://pubmed.ncbi.nlm.nih.gov/19650206/ relatesTo type: Has Comment In classifier: Comment citation: Eur Urol. 2009 May;55(5):1239-40. doi: 10.1016/j.eururo.2009.01.058. target: https://pubmed.ncbi.nlm.nih.gov/19650231/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1474-547X, ISOAbbreviation/Lancet, ISSN Linking/0140-6736, Medline Title Abbreviation/Lancet, NLM Unique ID/2985213R title: Lancet (London, England) publisherLocation: England citedMedium: Internet volume: 373 issue: 9660 articleDate: 2009-01-24 pageString: 301-8 publicationForm citedMedium: Internet without issue articleDate: 2008-12-16 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/19091394/ webLocation classifier: DOI Based url: https://doi.org/10.1016/S0140-6736(08)61815-2 classification type: Publishing Model classifier: Print Electronic classification type: Chemical classifier: Androgen Antagonists, Flutamide 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: Widmark A forenameInitials: A affiliation: Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden. entry contributor: Klepp O forenameInitials: O entry contributor: Solberg A forenameInitials: A entry contributor: Damber JE forenameInitials: JE entry contributor: Angelsen A forenameInitials: A entry contributor: Fransson P forenameInitials: P entry contributor: Lund JA forenameInitials: JA entry contributor: Tasdemir I forenameInitials: I entry contributor: Hoyer M forenameInitials: M entry contributor: Wiklund F forenameInitials: F entry contributor: Fosså SD forenameInitials: SD entry contributor: Scandinavian Prostate Cancer Group Study 7 entry contributor: Swedish Association for Urological Oncology 3 Generated Narrative: Practitioner #contributor0 name: Anders Widmark Generated Narrative: Practitioner #contributor1 name: Olbjørn Klepp Generated Narrative: Practitioner #contributor2 name: Arne Solberg Generated Narrative: Practitioner #contributor3 name: Jan-Erik Damber Generated Narrative: Practitioner #contributor4 name: Anders Angelsen Generated Narrative: Practitioner #contributor5 name: Per Fransson Generated Narrative: Practitioner #contributor6 name: Jo-Asmund Lund Generated Narrative: Practitioner #contributor7 name: Ilker Tasdemir Generated Narrative: Practitioner #contributor8 name: Morten Hoyer Generated Narrative: Practitioner #contributor9 name: Fredrik Wiklund Generated Narrative: Practitioner #contributor10 name: Sophie D Fosså Generated Narrative: Organization #contributor11 name: Scandinavian Prostate Cancer Group Study 7 Generated Narrative: Organization #contributor12 name: Swedish Association for Urological Oncology 3 Generated Narrative: ArtifactAssessment #meshHeading0 artifact: Citation 19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. content type: components (if present) include qualifier codings classifier: Aged freeToShare: true Components - 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Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Prostatectomy freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Prostatic Neoplasms freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: drug therapy Components - Type Classifier * is Major topic Yes component type: qualifier classifier: mortality Components - Type Classifier * is Major topic No component type: qualifier classifier: radiotherapy Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Severity of Illness Index freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Survival Analysis freeToShare: true Components - Type Classifier * qualifier is not a major topic
Scandinavian Prostate Cancer Group Study 7
Swedish Association for Urological Oncology 3
components (if present) include qualifier codings
19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III 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
Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial.
**BACKGROUND:** Several studies have shown the efficacy of endocrine therapy in combination with radiotherapy in high-risk prostate cancer. To assess the effect of radiotherapy, we did an open phase III study comparing endocrine therapy with and without local radiotherapy, followed by castration on progression. **METHODS:** This randomised trial included men from 47 centres in Norway, Sweden, and Denmark. Between February, 1996, and December, 2002, 875 patients with locally advanced prostate cancer (T3; 78%; PSA<70; N0; M0) were centrally randomly assigned by computer to endocrine treatment alone (3 months of total androgen blockade followed by continuous endocrine treatment using flutamide; 439 patients), or to the same endocrine treatment combined with radiotherapy (436 patients). The primary endpoint was prostate-cancer-specific survival, and analysis was by intention to treat. This study is registered as an international standard randomised controlled trial, number ISRCTN01534787. **FINDINGS:** After a median follow-up of 7.6 years, 79 men in the endocrine alone group and 37 men in the endocrine plus radiotherapy group had died of prostate cancer. The cumulative incidence at 10 years for prostate-cancer-specific mortality was 23.9% in the endocrine alone group and 11.9% in the endocrine plus radiotherapy group (difference 12.0%, 95% CI 4.9-19.1%), for a relative risk of 0.44 (0.30-0.66). At 10 years, the cumulative incidence for overall mortality was 39.4% in the endocrine alone group and 29.6% in the endocrine plus radiotherapy group (difference 9.8%, 0.8-18.8%), for a relative risk of 0.68 (0.52-0.89). Cumulative incidence at 10 years for PSA recurrence was substantially higher in men in the endocrine-alone group (74.7%vs 25.9%, p<0.0001; HR 0.16; 0.12-0.20). After 5 years, urinary, rectal, and sexual problems were slightly more frequent in the endocrine plus radiotherapy group. **INTERPRETATION:** In patients with locally advanced or high-risk local prostate cancer, addition of local radiotherapy to endocrine treatment halved the 10-year prostate-cancer-specific mortality, and substantially decreased overall mortality with fully acceptable risk of side-effects compared with endocrine treatment alone. In the light of these data, endocrine treatment plus radiotherapy should be the new standard.
Classifier added by Computable Publishing LLC
Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.