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)
- Author(s)
- Conduit, C; Mak, B; Qu, W; Di Lulio, J; Burder, R; Bressel, M; Cusick, T; Dhillon, HM; De Abreu Lourenco, R; Underhill, C; Torres, J; Crumbaker, M; Honeyball, F; Linton, A; Allen, R; Davis, ID; Clark, SJ; Horvath, LG; Mahon, KL;
- Journal Title
- Therapeutic Advances in Medical Oncology
- Publication Type
- 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/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.
- Keywords
- biomarkers; glutathione s-transferase Pi; patient-reported outcome measures; prostate neoplasms; prostate-specific antigen; quality of life
- Department(s)
- Biostatistics and Clinical Trials
- PubMed ID
- 35465297
- Publisher's Version
- https://doi.org/10.1177/17588359221092486
- Open Access at Publisher's Site
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Creation Date: 2024-10-17 03:12:12
Last Modified: 2024-10-17 03:12:37