19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. - XML Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

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: 19091394 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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    <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p class="res-header-id"><b>Generated Narrative: Citation 179627</b></p><a name="179627"> </a><a name="hc179627"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 21; Last updated: 2025-10-13 12:34:35+0000; Language: en</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-journal-article-citation.html">JournalArticleCitation</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="https://fevir.net/resources/Citation/179627">https://fevir.net/resources/Citation/179627</a></p><p><b>identifier</b>: FEvIR Object Identifier/179627, <code>https://pubmed.ncbi.nlm.nih.gov</code>/19091394</p><p><b>title</b>: 19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial.</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href="mailto:support@computablepublishing.com">support@computablepublishing.com</a></p><p><b>description</b>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</div><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="http://terminology.hl7.org/7.1.0/CodeSystem-citation-classification-type.html#citation-classification-type-fevir-platform-use">Citation Classification Type: fevir-platform-use</a> (FEvIR Platform Use)</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/citation-artifact-classifier medline-base}">Medline Base</span></td></tr></table><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>approvalDate</b>: 2009-02-05</p><p><b>lastReviewDate</b>: 2022-03-30</p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/citation-classification-type citation-source}">Citation Source</span></p><p><b>classifier</b>: <span title="Codes:">MEDLINE</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/citation-classification-type medline-owner}">MEDLINE Citation Owner</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#owner_value NLM}">National Library of Medicine, Index Section</span></p></blockquote><p><b>currentState</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type medline-medline}">Medline Citation Status of Medline</span>, <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-publication-status-ppublish}">PubMed PublicationStatus of ppublish</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --&gt; 2008-12-19 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pubmed}">PubMed Pubstatus of Pubmed</span></p><p><b>period</b>: ?? --&gt; 2008-12-19 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-medline}">PubMed Pubstatus of Medline</span></p><p><b>period</b>: ?? --&gt; 2009-02-06 09:00:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/19091394, <code>https://doi.org</code>/10.1016/S0140-6736(08)61815-2, pii/S0140-6736(08)61815-2</p><p><b>relatedIdentifier</b>: ISRCTN01534787</p><h3>Titles</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/title-type primary}">Primary title</span></td><td><div><p>Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial.</p>
</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-abstract-type primary-human-use}">Primary human use</span></td><td><div><p><strong>BACKGROUND:</strong> 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.
<strong>METHODS:</strong> 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&lt;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.
<strong>FINDINGS:</strong> 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&lt;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.
<strong>INTERPRETATION:</strong> 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.</p>
</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Correction In</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016425}">Published Erratum</span></p><p><b>citation</b>: </p><div><p>Lancet. 2009 Apr 4;373(9670):1174</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Has Comment In</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Lancet. 2009 Jan 24;373(9660):274-6. doi: 10.1016/S0140-6736(08)61816-4.</p>
</div><p><b>target</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/19091392/">https://pubmed.ncbi.nlm.nih.gov/19091392/</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Has Comment In</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Nat Rev Urol. 2009 May;6(5):250-1. doi: 10.1038/nrurol.2009.56.</p>
</div><p><b>target</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/19424171/">https://pubmed.ncbi.nlm.nih.gov/19424171/</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Has Comment In</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Ann Intern Med. 2009 Jun 16;150(12):JC6-6. doi: 10.7326/0003-4819-150-12-200906160-02006.</p>
</div><p><b>target</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/19528551/">https://pubmed.ncbi.nlm.nih.gov/19528551/</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Has Comment In</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Eur Urol. 2009 May;55(5):1240. doi: 10.1016/j.eururo.2009.01.059.</p>
</div><p><b>target</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/19650206/">https://pubmed.ncbi.nlm.nih.gov/19650206/</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Has Comment In</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Eur Urol. 2009 May;55(5):1239-40. doi: 10.1016/j.eururo.2009.01.058.</p>
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            value="**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&amp;lt;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&amp;lt;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."/>
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