Generated Narrative: Citation 179630 version: 19; Last updated: 2025-10-13 12:34:35+0000 Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: 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. identifier: FEvIR Object Identifier/179630, https://pubmed.ncbi.nlm.nih.gov/26092557, <a href="http://terminology.hl7.org/7.0.1/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 #xD;#xA;#xD;#xA;This 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. 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URIs as identifiers appear more commonly in FHIR.#xD;#xA;#xD;#xA;This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.30 version: 1.0.0-ballot3 title: 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. status: Active date: 2026-01-13 11:03:07+0000 author: Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: HL7 International / Clinical Decision Support contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide. UseContexts - Code Value[x] * Citation Classification Type: fevir-platform-use (FEvIR Platform Use) Medline Base jurisdiction: World copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/ approvalDate: 2016-04-14 lastReviewDate: 2024-02-10 classification type: Citation Source classifier: MEDLINE classification type: MEDLINE Citation Owner classifier: National Library of Medicine, Index Section currentState: Medline Citation Status of Medline, PubMed PublicationStatus of ppublish statusDate activity: PubMed Pubstatus of Received period: ?? --> 2015-02-20 statusDate activity: PubMed Pubstatus of Revised period: ?? --> 2015-05-08 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2015-05-11 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2015-06-21 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2015-06-21 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2016-04-15 06:00:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/26092557, https://doi.org/10.1016/j.urolonc.2015.05.012, pii/S1078-1439(15)00235-5 Titles - Type Text * Primary title 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. Abstracts - Type Text Copyright * Primary human use 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>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 © 2015 Elsevier Inc. All rights reserved. publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1873-2496, ISOAbbreviation/Urol Oncol, ISSN Linking/1078-1439, Medline Title Abbreviation/Urol Oncol, NLM Unique ID/9805460 title: Urologic oncology publisherLocation: United States citedMedium: Internet volume: 33 issue: 8 articleDate: 2015-08 pageString: 337.e1-6 publicationForm citedMedium: Internet without issue articleDate: 2015-06-16 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/26092557/ webLocation classifier: DOI Based url: https://doi.org/10.1016/j.urolonc.2015.05.012 classification type: Publishing Model classifier: Print Electronic classification type: Keyword artifactAssessment: Keywords provided by NOTNLM classification type: Chemical classifier: Androgen Antagonists, Taxoids, Docetaxel classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't classification type: Knowledge Artifact Type classifier: Journal Article artifactAssessment: Classifier added by Computable Publishing LLC classification type: Citation subset classifier: IM contributorship complete: true entry contributor: Rajan P forenameInitials: P affiliation: Institute of Cancer Sciences, University of Glasgow, UK. Electronic address: p.rajan@beatson.gla.ac.uk. entry contributor: Frew JA forenameInitials: JA affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. entry contributor: Wilson JM forenameInitials: JM affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. entry contributor: Azzabi AS forenameInitials: AS affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. entry contributor: McMenemin RM forenameInitials: RM affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. entry contributor: Stockley J forenameInitials: J affiliation: Institute of Cancer Sciences, University of Glasgow, UK. entry contributor: Soomro NA forenameInitials: NA affiliation: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. entry contributor: Durkan G forenameInitials: G affiliation: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. entry contributor: Pedley ID forenameInitials: ID affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. entry contributor: Leung HY forenameInitials: HY affiliation: Institute of Cancer Sciences, University of Glasgow, UK; Cancer Research UK Beatson Institute, Bearsden, UK. Electronic address: h.leung@beatson.gla.ac.uk. Generated Narrative: ArtifactAssessment #keywords0 artifact: 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. content classifier: Androgen deprivation therapy content classifier: Docetaxel content classifier: Prostate cancer content classifier: Prostatic biopsy Generated Narrative: Practitioner #contributor0 name: Prabhakar Rajan Generated Narrative: Practitioner #contributor1 name: John A Frew Generated Narrative: Practitioner #contributor2 name: James M Wilson Generated Narrative: Practitioner #contributor3 name: Ashraf S T Azzabi Generated Narrative: Practitioner #contributor4 name: Rhona M McMenemin Generated Narrative: Practitioner #contributor5 name: Jacqueline Stockley Generated Narrative: Practitioner #contributor6 name: Naeem A Soomro Generated Narrative: Practitioner #contributor7 name: Garrett Durkan Generated Narrative: Practitioner #contributor8 name: Ian D Pedley Generated Narrative: Practitioner #contributor9 name: Hing Y Leung Generated Narrative: ArtifactAssessment #meshHeading0 artifact: 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. content type: components (if present) include qualifier codings classifier: Aged freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Androgen Antagonists freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: administration & dosage Components - Type Classifier * is Major topic No component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Biopsy freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Docetaxel freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Feasibility Studies freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Humans freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Male freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Middle Aged freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Prostatic Neoplasms freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: drug therapy Components - Type Classifier * is Major topic Yes component type: qualifier classifier: surgery Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Taxoids freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: administration & dosage Components - Type Classifier * is Major topic No component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes
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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.
Computable Publishing®: MEDLINE-to-FEvIR Converter
HL7 International / Clinical Decision Support
This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
National Library of Medicine, Index Section
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.
**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>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 © 2015 Elsevier Inc. All rights reserved.
Classifier added by Computable Publishing LLC
Institute of Cancer Sciences, University of Glasgow, UK. Electronic address: p.rajan@beatson.gla.ac.uk.
Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
Institute of Cancer Sciences, University of Glasgow, UK.
Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
Institute of Cancer Sciences, University of Glasgow, UK; Cancer Research UK Beatson Institute, Bearsden, UK. Electronic address: h.leung@beatson.gla.ac.uk.