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Generated Narrative: Citation 179627
version: 21; Last updated: 2025-10-13 12:34:35+0000
Profile: JournalArticleCitation
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identifier: FEvIR Object Identifier/179627, https://pubmed.ncbi.nlm.nih.gov/19091394, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.29
version: 1.0.0-ballot3
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
date: 2026-02-10 14:00:26+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.
| 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: 2009-02-05
lastReviewDate: 2022-03-30
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https://pubmed.ncbi.nlm.nih.gov/19091394,https://doi.org/10.1016/S0140-6736(08)61815-2, pii/S0140-6736(08)61815-2relatedIdentifier: 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
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classifier: Comment
citation:
Lancet. 2009 Jan 24;373(9660):274-6. doi: 10.1016/S0140-6736(08)61816-4.
relatesTo
type: Has Comment In
classifier: Comment
citation:
Nat Rev Urol. 2009 May;6(5):250-1. doi: 10.1038/nrurol.2009.56.
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.
relatesTo
type: Has Comment In
classifier: Comment
citation:
Eur Urol. 2009 May;55(5):1240. doi: 10.1016/j.eururo.2009.01.059.
relatesTo
type: Has Comment In
classifier: Comment
citation:
Eur Urol. 2009 May;55(5):1239-40. doi: 10.1016/j.eururo.2009.01.058.
publicationForm
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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
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contributor: Widmark A
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affiliation: Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.
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"text": "Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial."
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"text": "**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.\n**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.\n**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.\n**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."
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