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 1.0.0-ballot3 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
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: Citation 179630</b></p><a name=\"179630\"> </a><a name=\"hc179630\"> </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: 19; 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/179630\">https://fevir.net/resources/Citation/179630</a></p><p><b>identifier</b>: FEvIR Object Identifier/179630, <code>https://pubmed.ncbi.nlm.nih.gov</code>/26092557</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>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>\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://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>\n</div><p><b>approvalDate</b>: 2016-04-14</p><p><b>lastReviewDate</b>: 2024-02-10</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-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>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>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>Type</b></td><td><b>Text</b></td><td><b>Copyright</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 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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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>pageString</b>: 337.e1-6</p></blockquote><blockquote><p><b>publicationForm</b></p><p><b>citedMedium</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/cited-artifact-classification-type publishing-model}\">Publishing Model</span></p><p><b>classifier</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/citation-artifact-classifier Print-Electronic}\">Print Electronic</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/cited-artifact-classification-type chemical}\">Chemical</span></p><p><b>classifier</b>: <span title=\"Codes:{https://www.nlm.nih.gov/mesh D000726}\">Androgen Antagonists</span>, <span title=\"Codes:{https://www.nlm.nih.gov/mesh D043823}\">Taxoids</span>, <span title=\"Codes:{https://www.cas.org/support/documentation/chemical-substances 15H5577CQD}, {https://www.nlm.nih.gov/mesh D000077143}\">Docetaxel</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/cited-artifact-classification-type publication-type}\">Publication type</span></p><p><b>classifier</b>: <span title=\"Codes:{https://www.nlm.nih.gov/mesh D017427}\">Clinical Trial, Phase II</span>, <span title=\"Codes:{https://www.nlm.nih.gov/mesh D016428}\">Journal Article</span>, <span title=\"Codes:{https://www.nlm.nih.gov/mesh D016449}\">Randomized Controlled Trial</span>, <span title=\"Codes:{https://www.nlm.nih.gov/mesh 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://terminology.hl7.org/CodeSystem/cited-artifact-classification-type knowledge-artifact-type}\">Knowledge Artifact Type</span></p><p><b>classifier</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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><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><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><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><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><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><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><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><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><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><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><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><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://terminology.hl7.org/CodeSystem/cited-artifact-classification-type mesh-heading}\">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title=\"Codes:{https://www.nlm.nih.gov/mesh 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 title=\"Codes:\">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-classification-type mesh-heading}\">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title=\"Codes:{https://www.nlm.nih.gov/mesh D000726}\">Androgen Antagonists</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title=\"Codes:\">qualifier</span></p><p><b>classifier</b>: <span title=\"Codes:\">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title=\"Codes:\">qualifier</span></p><p><b>classifier</b>: <span title=\"Codes:{https://www.nlm.nih.gov/mesh Q000008}\">administration & dosage</span></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:\">is Major topic</span></td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49487}\">No</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title=\"Codes:\">qualifier</span></p><p><b>classifier</b>: <span title=\"Codes:{https://www.nlm.nih.gov/mesh Q000627}\">therapeutic use</span></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:\">is Major 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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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