Generated Narrative: Citation 179630

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/https://fevir.net/FOI/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

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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: 2024-12-19 14:29:51+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

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approvalDate: 2016-04-14

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period: ?? --> 2015-06-21 06:00:00+0000

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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	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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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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url: https://pubmed.ncbi.nlm.nih.gov/26092557/

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url: https://doi.org/10.1016/j.urolonc.2015.05.012

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type: Chemical

classifier: Androgen Antagonists, Taxoids, Docetaxel

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classifier: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

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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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Generated Narrative: Practitioner #contributor0

name: Prabhakar Rajan

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name: John A Frew

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name: Ashraf S T Azzabi

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name: Rhona M McMenemin

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name: Jacqueline Stockley

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name: Naeem A Soomro

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name: Garrett Durkan

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name: Ian D Pedley

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name: Hing Y Leung

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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.

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