Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Active as of 2024-12-19 |
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🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/journal-article-citation"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Citation 179630</b></p><a name=\"179630\"> </a><a name=\"hc179630\"> </a><a name=\"179630-en-US\"> </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: 8; Last updated: 2024-11-22 19:27:42+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-journal-article-citation.html\">JournalArticleCitation</a></p></div><p><b>url</b>: <a href=\"Citation-179630.html\">Citation 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.</a></p><p><b>identifier</b>: FEvIR Object Identifier/https://fevir.net/FOI/179630, <code>https://pubmed.ncbi.nlm.nih.gov</code>/26092557, <a href=\"http://terminology.hl7.org/6.1.0/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 \r\n\r\nThis 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: \r\n\r\nNote 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.\r\n\r\nThis OID may also be used in CD.codeSystem.\">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.30</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.</p><p><b>status</b>: Active</p><p><b>date</b>: 2024-12-19 14:29:51+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href=\"http://www.hl7.org/Special/committees/dss\">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>\n</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://hl7.org/fhir/R5/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://hl7.org/fhir/citation-artifact-classifier medline-base}\">Medline Base</span></td></tr></table><p><b>jurisdiction</b>: <span title=\"Codes:{http://unstats.un.org/unsd/methods/m49/m49.htm 001}\">World</span></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><p><b>approvalDate</b>: 2016-04-14</p><p><b>lastReviewDate</b>: 2024-02-10</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/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://hl7.org/fhir/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-received}\">PubMed Pubstatus of Received</span></p><p><b>period</b>: ?? --> 2015-02-20</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title=\"Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-revised}\">PubMed Pubstatus of Revised</span></p><p><b>period</b>: ?? --> 2015-05-08</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title=\"Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-accepted}\">PubMed Pubstatus of Accepted</span></p><p><b>period</b>: ?? --> 2015-05-11</p></blockquote><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>: ?? --> 2015-06-21 06:00:00+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>: ?? --> 2015-06-21 06:00:00+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>: ?? --> 2016-04-15 06:00:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26092557, <code>https://doi.org</code>/10.1016/j.urolonc.2015.05.012, pii/S1078-1439(15)00235-5</p><h3>Titles</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/title-type primary}\">Primary title</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></td><td><div><p>Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.</p>\n</div></td></tr></table><h3>Abstracts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style=\"display: none\">*</td><td><div><p><strong>BACKGROUND AND OBJECTIVE:</strong> Sequential tissue biopsies taken during clinical trials of novel systemic anticancer therapies for advanced prostate cancer (PCa) may aid pharmacodynamic evaluation and biomarker discovery. We conducted a single institution phase-II open-labeled randomized study to assess the safety, tolerability, and early efficacy of docetaxel chemotherapy plus androgen deprivation therapy (ADT) vs. ADT alone for patients with advanced non-castration-resistant PCa with sequential prostatic biopsies.\n<strong>PATIENTS AND METHODS:</strong> We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3-4/N0-1/M0-1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound-guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling.\n<strong>RESULTS:</strong> Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P>0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms.\n<strong>CONCLUSIONS:</strong> Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non-castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies.</p>\n</div></td><td><div><p>Copyright © 2015 Elsevier Inc. All rights reserved.</p>\n</div></td></tr></table><blockquote><p><b>publicationForm</b></p><blockquote><p><b>publishedIn</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/published-in-type D020492}\">Periodical</span></p><p><b>identifier</b>: Electronic ISSN Type/1873-2496, ISOAbbreviation/Urol Oncol, ISSN Linking/1078-1439, Medline Title Abbreviation/Urol Oncol, NLM Unique ID/9805460</p><p><b>title</b>: Urologic oncology</p><p><b>publisherLocation</b>: United States</p></blockquote><p><b>citedMedium</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-medium internet}\">Internet</span></p><p><b>volume</b>: 33</p><p><b>issue</b>: 8</p><p><b>articleDate</b>: 2015-08</p><p><b>publicationDateText</b>: 2015-Aug</p><p><b>language</b>: <span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></p><p><b>pageString</b>: 337.e1-6</p></blockquote><blockquote><p><b>publicationForm</b></p><p><b>citedMedium</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-medium internet-without-issue}\">Internet without issue</span></p><p><b>articleDate</b>: 2015-06-16</p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/artifact-url-classifier abstract}\">Abstract</span></p><p><b>url</b>: <a href=\"https://pubmed.ncbi.nlm.nih.gov/26092557/\">https://pubmed.ncbi.nlm.nih.gov/26092557/</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/artifact-url-classifier doi-based}\">DOI Based</span></p><p><b>url</b>: <a href=\"https://doi.org/10.1016/j.urolonc.2015.05.012\">https://doi.org/10.1016/j.urolonc.2015.05.012</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type publishing-model}\">Publishing Model</span></p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/citation-artifact-classifier Print-Electronic}\">Print Electronic</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type keyword}\">Keyword</span></p><p><b>artifactAssessment</b>: <a href=\"#hc179630/keywords0\">Keywords provided by NOTNLM</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type chemical}\">Chemical</span></p><p><b>classifier</b>: <span title=\"Codes:{https://meshb.nlm.nih.gov/ D000726}\">Androgen Antagonists</span>, <span title=\"Codes:{https://meshb.nlm.nih.gov/ D043823}\">Taxoids</span>, <span title=\"Codes:{https://www.cas.org/support/documentation/chemical-substances 15H5577CQD}, {https://meshb.nlm.nih.gov/ D000077143}\">Docetaxel</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}\">MeSH heading</span></p><p><b>artifactAssessment</b>: <a href=\"#hc179630/meshHeading0\">ArtifactAssessment: artifact[x] = this resource</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type publication-type}\">Publication type</span></p><p><b>classifier</b>: <span title=\"Codes:{https://meshb.nlm.nih.gov/ D017427}\">Clinical Trial, Phase II</span>, <span title=\"Codes:{https://meshb.nlm.nih.gov/ D016428}\">Journal Article</span>, <span title=\"Codes:{https://meshb.nlm.nih.gov/ D016449}\">Randomized Controlled Trial</span>, <span title=\"Codes:{https://meshb.nlm.nih.gov/ D013485}\">Research Support, Non-U.S. Gov't</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type knowledge-artifact-type}\">Knowledge Artifact Type</span></p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}\">Journal Article</span></p><p><b>artifactAssessment</b>: Classifier added by Computable Publishing LLC</p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type citation-subset}\">Citation subset</span></p><p><b>classifier</b>: <span title=\"Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#citationsubset IM}\">IM</span></p></blockquote><blockquote><p><b>contributorship</b></p><p><b>complete</b>: true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor0\">Rajan P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Institute of Cancer Sciences, University of Glasgow, UK. Electronic address: p.rajan@beatson.gla.ac.uk.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor1\">Frew JA</a></p><p><b>forenameInitials</b>: JA</p><p><b>affiliation</b>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor2\">Wilson JM</a></p><p><b>forenameInitials</b>: JM</p><p><b>affiliation</b>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor3\">Azzabi AS</a></p><p><b>forenameInitials</b>: AS</p><p><b>affiliation</b>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor4\">McMenemin RM</a></p><p><b>forenameInitials</b>: RM</p><p><b>affiliation</b>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor5\">Stockley J</a></p><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: Institute of Cancer Sciences, University of Glasgow, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor6\">Soomro NA</a></p><p><b>forenameInitials</b>: NA</p><p><b>affiliation</b>: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor7\">Durkan G</a></p><p><b>forenameInitials</b>: G</p><p><b>affiliation</b>: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor8\">Pedley ID</a></p><p><b>forenameInitials</b>: ID</p><p><b>affiliation</b>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href=\"#hc179630/contributor9\">Leung HY</a></p><p><b>forenameInitials</b>: HY</p><p><b>affiliation</b>: Institute of Cancer Sciences, University of Glasgow, UK; Cancer Research UK Beatson Institute, Bearsden, UK. Electronic address: h.leung@beatson.gla.ac.uk.</p></blockquote></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: ArtifactAssessment #keywords0</b></p><a name=\"179630/keywords0\"> </a><a name=\"hc179630/keywords0\"> </a><a name=\"179630/keywords0-en-US\"> </a><p><b>artifact</b>: <a href=\"#hc179630\">Citation 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.</a></p><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title=\"Codes:\">Androgen deprivation therapy</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title=\"Codes:\">Docetaxel</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title=\"Codes:\">Prostate cancer</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title=\"Codes:\">Prostatic biopsy</span></p></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor0</b></p><a name=\"179630/contributor0\"> </a><a name=\"hc179630/contributor0\"> </a><a name=\"179630/contributor0-en-US\"> </a><p><b>name</b>: Prabhakar Rajan </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor1</b></p><a name=\"179630/contributor1\"> </a><a name=\"hc179630/contributor1\"> </a><a name=\"179630/contributor1-en-US\"> </a><p><b>name</b>: John A Frew </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor2</b></p><a name=\"179630/contributor2\"> </a><a name=\"hc179630/contributor2\"> </a><a name=\"179630/contributor2-en-US\"> </a><p><b>name</b>: James M Wilson </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor3</b></p><a name=\"179630/contributor3\"> </a><a name=\"hc179630/contributor3\"> </a><a name=\"179630/contributor3-en-US\"> </a><p><b>name</b>: Ashraf S T Azzabi </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor4</b></p><a name=\"179630/contributor4\"> </a><a name=\"hc179630/contributor4\"> </a><a name=\"179630/contributor4-en-US\"> </a><p><b>name</b>: Rhona M McMenemin </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor5</b></p><a name=\"179630/contributor5\"> </a><a name=\"hc179630/contributor5\"> </a><a name=\"179630/contributor5-en-US\"> </a><p><b>name</b>: Jacqueline Stockley </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor6</b></p><a name=\"179630/contributor6\"> </a><a name=\"hc179630/contributor6\"> </a><a name=\"179630/contributor6-en-US\"> </a><p><b>name</b>: Naeem A Soomro </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor7</b></p><a name=\"179630/contributor7\"> </a><a name=\"hc179630/contributor7\"> </a><a name=\"179630/contributor7-en-US\"> </a><p><b>name</b>: Garrett Durkan </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor8</b></p><a name=\"179630/contributor8\"> </a><a name=\"hc179630/contributor8\"> </a><a name=\"179630/contributor8-en-US\"> </a><p><b>name</b>: Ian D Pedley </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Practitioner #contributor9</b></p><a name=\"179630/contributor9\"> </a><a name=\"hc179630/contributor9\"> </a><a name=\"179630/contributor9-en-US\"> </a><p><b>name</b>: Hing Y Leung </p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: ArtifactAssessment #meshHeading0</b></p><a name=\"179630/meshHeading0\"> </a><a name=\"hc179630/meshHeading0\"> </a><a name=\"179630/meshHeading0-en-US\"> </a><p><b>artifact</b>: <a href=\"#hc179630\">Citation 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.</a></p><blockquote><p><b>content</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}\">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title=\"Codes:{https://meshb.nlm.nih.gov/ D000368}\">Aged</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">qualifier</span></td><td><span 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"text" : "**BACKGROUND AND OBJECTIVE:** Sequential tissue biopsies taken during clinical trials of novel systemic anticancer therapies for advanced prostate cancer (PCa) may aid pharmacodynamic evaluation and biomarker discovery. We conducted a single institution phase-II open-labeled randomized study to assess the safety, tolerability, and early efficacy of docetaxel chemotherapy plus androgen deprivation therapy (ADT) vs. ADT alone for patients with advanced non-castration-resistant PCa with sequential prostatic biopsies.\n**PATIENTS AND METHODS:** We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3-4/N0-1/M0-1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound-guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling.\n**RESULTS:** Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P>0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms.\n**CONCLUSIONS:** Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non-castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies.",
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
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