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Article Abstract
Objective: To determine the efficacy and safety of intermittent docetaxel chemotherapy guided by circulating methylated glutathione S-transferase Pi-1 () 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 q3w will be pre-screened for detectable at baseline ± following two cycles of treatment. Those with detectable plasma 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 becomes detectable) or Arm (continue docetaxel 75 mg/m 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 as a novel biomarker to guide treatment de-escalation in metastatic CRPC.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9019311 | PMC |
| http://dx.doi.org/10.1177/17588359221092486 | DOI Listing |
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