@article{531a5422c2e5401d9aa5662decd3d3c6,
title = "GUIDE: a randomised non-comparative phase II trial of biomarker-driven intermittent docetaxel versus standard-of-care docetaxel in metastatic castration-resistant prostate cancer (clinical trial protocol)",
abstract = "Objective: To determine the efficacy and safety of intermittent docetaxel chemotherapy guided by circulating methylated glutathione S-transferase Pi-1 (mGSTP1) in men with metastatic castration-resistant prostate cancer (CRPC). Patients and Methods: GUIDE (NCT04918810) is a randomised, two-arm, non-comparative phase-2 trial recruiting 120 patients at six Australian centres. Patients with Prostate Cancer Working Group-3 defined metastatic CRPC who are commencing docetaxel 75 mg/m2 q3w will be pre-screened for detectable mGSTP1 at baseline ± following two cycles of treatment. Those with detectable plasma mGSTP1 at baseline that becomes undetectable after two cycles of chemotherapy will be eligible for GUIDE. Prior to Cycle 4 of docetaxel, these patients are randomised 2:1 to one of two treatment arms: Arm A (cease docetaxel and reinstitute if mGSTP1 becomes detectable) or Arm B (continue docetaxel 75 mg/m2 q3w in accordance with clinician{\textquoteright}s usual practice). The primary endpoint is radiographic progression-free survival. Secondary endpoints include time on treatment holidays, safety, patient-reported outcomes, overall survival, health resource use, and cost associated with treatment. Enrolment commenced November 2021. Results and Conclusion: The results of this trial will generate data on the clinical utility of mGSTP1 as a novel biomarker to guide treatment de-escalation in metastatic CRPC.",
keywords = "biomarkers, glutathione s-transferase Pi, patient-reported outcome measures, prostate neoplasms, prostate-specific antigen, quality of life",
author = "Ciara Conduit and Blossom Mak and Wenjia Qu and Lulio, {Juliana Di} and Ronan Burder and Matthias Bressel and Thomas Cusick and Dhillon, {Haryana M.} and Louren{\c c}o, {Richard De Abreu} and Craig Underhill and Javier Torres and Megan Crumbaker and Florian Honeyball and Anthony Linton and Ray Allen and Davis, {Ian D.} and Clark, {Susan J.} and Horvath, {Lisa G.} and Mahon, {Kate L.}",
note = "Funding Information: This trial is sponsored by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group, with funding from ANZUP Discretionary Funding Initiative, ANZUP Below the Belt Research Fund, Chris O{\textquoteright}Brien Lifehouse Philanthropic Fund, the Twin Towns Foundation, the Cancer Institute of NSW, and the National Health and Medical Research Council. The trial was first registered at clinicaltrials.gov (NCT04918810) on 9 June 2021. Central ethical approval has been obtained from St Vincent{\textquoteright}s Hospital Human Research Ethics Committee (HREC 2021/ETH00523) in 2021. Local ethical and governance approval has been or will be obtained for six participating Australian sites. The study is being conducted in accordance with the Declaration of Helsinki, Note for Guidance on Good Clinical Practice, and in compliance with the applicable laws and regulations including the NHMRC National Statement on Ethical Conduct in Human Research, and the NHMRC Australian Code for Responsible Conduct of Research. All participants will provide written informed consent. Funding Information: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: ANZUP, Chris O{\textquoteright}Brien Lifehouse Philanthropic Fund and the Twin Towns Foundation, CINSW TPG (TPG172146), and NHMRC investigator grant (APP1196225). Publisher Copyright: {\textcopyright} The Author(s), 2022.",
year = "2022",
month = apr,
doi = "10.1177/17588359221092486",
language = "English",
volume = "14",
pages = "1--13",
journal = "Therapeutic Advances in Medical Oncology",
issn = "1758-8340",
publisher = "SAGE Publications Ltd",
}
