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 2024-11-01 |
Generated Narrative: Citation 179630
version: 7; Last updated: 2024-07-18 17:58:30+0000
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identifier: FEvIR Object Identifier/179630, https://pubmed.ncbi.nlm.nih.gov
/26092557, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.30
version: 2.0.0-ballot
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: 2024-11-01 10:20:00+0000
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.
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https://creativecommons.org/licenses/by-nc-sa/4.0/
approvalDate: 2016-04-14
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citedArtifact
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https://pubmed.ncbi.nlm.nih.gov
/26092557,https://doi.org
/10.1016/j.urolonc.2015.05.012, pii/S1078-1439(15)00235-5Titles
Type Language Text Primary title English 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
Text Copyright 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
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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
publicationDateText: 2015-Aug
language: English
pageString: 337.e1-6
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articleDate: 2015-06-16
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type: Chemical
classifier: Androgen Antagonists, Taxoids, Docetaxel
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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.
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name: John A Frew
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