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. - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-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

Example 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.

Active as of 2024-04-27

Generated Narrative: Citation

Resource Citation "179630" Version "1" Updated "2023-11-26 22:35:30+0000"

url: https://fevir.net/resources/Citation/179630

identifier: FEvIR Object Identifier/179630, https://pubmed.ncbi.nlm.nih.gov/26092557

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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: 2024-04-27 20:42:39+0000

publisher: HL7 International / Clinical Decision Support

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identifier: https://pubmed.ncbi.nlm.nih.gov/26092557, https://doi.org/10.1016/j.urolonc.2015.05.012, pii/S1078-1439(15)00235-5
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* Primary title (Title Type#primary) English (Tags for the Identification of Languages#en) 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
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* **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.
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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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