Journal
THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
Volume 14, Issue -, Pages -Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/17588359221092486
Keywords
biomarkers; glutathione s-transferase Pi; patient-reported outcome measures; prostate neoplasms; prostate-specific antigen; quality of life
Categories
Funding
- ANZUP
- Chris O'Brien Lifehouse Philanthropic Fund
- Twin Towns Foundation
- CINSW TPG [TPG172146]
- NHMRC investigator grant [APP1196225]
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The study aims to assess the efficacy and safety of intermittent docetaxel chemotherapy guided by circulating mGSTP1 in men with metastatic castration-resistant prostate cancer. It plans to recruit 120 patients for randomised observation and evaluate the utility of mGSTP1 as a biomarker in guiding treatment.
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/m(2) 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/m(2) q3w in accordance with clinician'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.
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