Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-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 1.0.0-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 2024-05-16 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Citation</b><a name="179630"> </a><a name="hc179630"> </a></p><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">ResourceCitation "179630" Version "1" Updated "2023-11-26 22:35:30+0000" </p></div><p><b>url</b>: <code>https://fevir.net/resources/Citation/179630</code></p><p><b>identifier</b>: FEvIR Object Identifier/179630, <code>https://pubmed.ncbi.nlm.nih.gov</code>/26092557</p><p><b>version</b>: 1.0.0-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>: 2024-05-16 12:17:54+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>: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p><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>FEvIR Platform Use (Details: Citation Classification Type code fevir-platform-use = 'FEvIR Platform Use', stated as 'FEvIR Platform Use')</td><td>Medline Base <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#medline-base)</span></td></tr></table><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>approvalDate</b>: 2016-04-14</p><p><b>lastReviewDate</b>: 2022-01-29</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: Citation Source <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html">Citation Classification Type</a>#citation-source)</span></p><p><b>classifier</b>: MEDLINE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: MEDLINE Citation Owner <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html">Citation Classification Type</a>#medline-owner)</span></p><p><b>classifier</b>: National Library of Medicine, Index Section <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (elements_descriptions.html#owner_value#NLM)</span></p></blockquote><p><b>currentState</b>: Medline Citation Status of Medline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#medline-medline)</span>, PubMed PublicationStatus of ppublish <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-publication-status-ppublish)</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Received <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-received)</span></p><p><b>period</b>: ?? --> 2015-02-20</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Revised <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-revised)</span></p><p><b>period</b>: ?? --> 2015-05-08</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Accepted <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-accepted)</span></p><p><b>period</b>: ?? --> 2015-05-11</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Entrez <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-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>: PubMed Pubstatus of Pubmed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-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>: PubMed Pubstatus of Medline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-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>Primary title <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-title-type.html">Title Type</a>#primary)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td><td>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.</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>**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.
**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.
**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&gt;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.
**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.</td><td>Copyright © 2015 Elsevier Inc. All rights reserved.</td></tr></table><blockquote><p><b>publicationForm</b></p><h3>PublishedIns</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Identifier</b></td><td><b>Title</b></td><td><b>PublisherLocation</b></td></tr><tr><td style="display: none">*</td><td>Periodical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-published-in-type.html">Published In Type</a>#D020492)</span></td><td>Electronic ISSN Type/1873-2496, ISOAbbreviation/Urol Oncol, ISSN Linking/1078-1439, Medline Title Abbreviation/Urol Oncol, NLM Unique ID/9805460</td><td>Urologic oncology</td><td>United States</td></tr></table><p><b>citedMedium</b>: Internet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-medium.html">Cited Medium</a>#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>: English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></p><p><b>pageString</b>: 337.e1-6</p></blockquote><blockquote><p><b>publicationForm</b></p><p><b>citedMedium</b>: Internet without issue <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-medium.html">Cited Medium</a>#internet-without-issue)</span></p><p><b>articleDate</b>: 2015-06-16</p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: Abstract <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#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>: DOI Based <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#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>: Publishing Model <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#publishing-model)</span></p><p><b>classifier</b>: Print Electronic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#Print-Electronic)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Keyword <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#keyword)</span></p><p><b>artifactAssessment</b>: <a name="hckeywords0"> </a></p><blockquote><p/><p><a name="keywords0"> </a></p><p><a name="hckeywords0"> </a></p><p><b>artifact</b>: <a href="#">#</a></p><blockquote><p><b>content</b></p><p><b>classifier</b>: Androgen deprivation therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: Docetaxel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: Prostate cancer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: Prostatic biopsy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></blockquote></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#chemical)</span></p><p><b>classifier</b>: Androgen Antagonists <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000726)</span>, Taxoids <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D043823)</span>, Docetaxel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (chemical-substances#15H5577CQD; #D000077143)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: MeSH Heading <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading)</span></p><p><b>artifactAssessment</b>: <a name="hcmeshHeading0"> </a></p><blockquote><p/><p><a name="meshHeading0"> </a></p><p><a name="hcmeshHeading0"> </a></p><p><b>artifact</b>: <a href="#">#</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Aged <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000368)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Androgen Antagonists <span style="background: LightGoldenRodYellow; 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margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Biopsy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D001706)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; 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margin: 4px; border: 1px solid khaki"> (#D008297)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Middle Aged <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D008875)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Prostatic Neoplasms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D011471)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: drug therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000188)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: surgery <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000601)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Taxoids <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D043823)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: administration & dosage <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000008)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote></blockquote></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Publication Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#publication-type)</span></p><p><b>classifier</b>: Clinical Trial, Phase II <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D017427)</span>, Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016428)</span>, Randomized Controlled Trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016449)</span>, Research Support, Non-U.S. Gov't <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D013485)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Knowledge Artifact Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#knowledge-artifact-type)</span></p><p><b>classifier</b>: Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D016428)</span></p><p><b>artifactAssessment</b>: <span>: Classifier added by Computable Publishing LLC</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Citation Subset <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#citation-subset)</span></p><p><b>classifier</b>: IM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (elements_descriptions.html#citationsubset#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 name="hcauthor0"> </a></p><blockquote><p/><p><a name="author0"> </a></p><p><a name="hcauthor0"> </a></p><p><b>name</b>: Prabhakar Rajan </p></blockquote><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: <span>: Institute of Cancer Sciences, University of Glasgow, UK. Electronic address: p.rajan@beatson.gla.ac.uk.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor1"> </a></p><blockquote><p/><p><a name="author1"> </a></p><p><a name="hcauthor1"> </a></p><p><b>name</b>: John A Frew </p></blockquote><p><b>forenameInitials</b>: JA</p><p><b>affiliation</b>: <span>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor2"> </a></p><blockquote><p/><p><a name="author2"> </a></p><p><a name="hcauthor2"> </a></p><p><b>name</b>: James M Wilson </p></blockquote><p><b>forenameInitials</b>: JM</p><p><b>affiliation</b>: <span>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor3"> </a></p><blockquote><p/><p><a name="author3"> </a></p><p><a name="hcauthor3"> </a></p><p><b>name</b>: Ashraf S T Azzabi </p></blockquote><p><b>forenameInitials</b>: AS</p><p><b>affiliation</b>: <span>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor4"> </a></p><blockquote><p/><p><a name="author4"> </a></p><p><a name="hcauthor4"> </a></p><p><b>name</b>: Rhona M McMenemin </p></blockquote><p><b>forenameInitials</b>: RM</p><p><b>affiliation</b>: <span>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor5"> </a></p><blockquote><p/><p><a name="author5"> </a></p><p><a name="hcauthor5"> </a></p><p><b>name</b>: Jacqueline Stockley </p></blockquote><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: <span>: Institute of Cancer Sciences, University of Glasgow, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor6"> </a></p><blockquote><p/><p><a name="author6"> </a></p><p><a name="hcauthor6"> </a></p><p><b>name</b>: Naeem A Soomro </p></blockquote><p><b>forenameInitials</b>: NA</p><p><b>affiliation</b>: <span>: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor7"> </a></p><blockquote><p/><p><a name="author7"> </a></p><p><a name="hcauthor7"> </a></p><p><b>name</b>: Garrett Durkan </p></blockquote><p><b>forenameInitials</b>: G</p><p><b>affiliation</b>: <span>: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor8"> </a></p><blockquote><p/><p><a name="author8"> </a></p><p><a name="hcauthor8"> </a></p><p><b>name</b>: Ian D Pedley </p></blockquote><p><b>forenameInitials</b>: ID</p><p><b>affiliation</b>: <span>: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor9"> </a></p><blockquote><p/><p><a name="author9"> </a></p><p><a name="hcauthor9"> </a></p><p><b>name</b>: Hing Y Leung </p></blockquote><p><b>forenameInitials</b>: HY</p><p><b>affiliation</b>: <span>: Institute of Cancer Sciences, University of Glasgow, UK; Cancer Research UK Beatson Institute, Bearsden, UK. Electronic address: h.leung@beatson.gla.ac.uk.</span></p></blockquote></blockquote></blockquote><hr/><blockquote><p><b>Generated Narrative: ArtifactAssessment #keywords0</b><a name="keywords0"> </a><a name="hckeywords0"> </a></p><p><b>artifact</b>: <a href="#">#</a></p><blockquote><p><b>content</b></p><p><b>classifier</b>: Androgen deprivation therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: Docetaxel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: Prostate cancer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: Prostatic biopsy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author0</b><a name="author0"> </a><a name="hcauthor0"> </a></p><p><b>name</b>: Prabhakar Rajan </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author1</b><a name="author1"> </a><a name="hcauthor1"> </a></p><p><b>name</b>: John A Frew </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author2</b><a name="author2"> </a><a name="hcauthor2"> </a></p><p><b>name</b>: James M Wilson </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author3</b><a name="author3"> </a><a name="hcauthor3"> </a></p><p><b>name</b>: Ashraf S T Azzabi </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author4</b><a name="author4"> </a><a name="hcauthor4"> </a></p><p><b>name</b>: Rhona M McMenemin </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author5</b><a name="author5"> </a><a name="hcauthor5"> </a></p><p><b>name</b>: Jacqueline Stockley </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author6</b><a name="author6"> </a><a name="hcauthor6"> </a></p><p><b>name</b>: Naeem A Soomro </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author7</b><a name="author7"> </a><a name="hcauthor7"> </a></p><p><b>name</b>: Garrett Durkan </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author8</b><a name="author8"> </a><a name="hcauthor8"> </a></p><p><b>name</b>: Ian D Pedley </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author9</b><a name="author9"> </a><a name="hcauthor9"> </a></p><p><b>name</b>: Hing Y Leung </p></blockquote><hr/><blockquote><p><b>Generated Narrative: ArtifactAssessment #meshHeading0</b><a name="meshHeading0"> </a><a name="hcmeshHeading0"> </a></p><p><b>artifact</b>: <a href="#">#</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Aged <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000368)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Androgen Antagonists <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000726)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: administration & dosage <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000008)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Biopsy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D001706)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Docetaxel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000077143)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Feasibility Studies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D005240)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Humans <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D006801)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Male <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D008297)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Middle Aged <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D008875)</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>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Prostatic Neoplasms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D011471)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; 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value="**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.
**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.
**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&gt;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.
**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."/>
<copyright value="Copyright © 2015 Elsevier Inc. All rights reserved."/>
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