Journal article

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)

C Conduit, B Mak, W Qu, JD Lulio, R Burder, M Bressel, T Cusick, HM Dhillon, RDA Lourenço, C Underhill, J Torres, M Crumbaker, F Honeyball, A Linton, R Allen, ID Davis, SJ Clark, LG Horvath, KL Mahon

Therapeutic Advances in Medical Oncology | Published : 2022

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 elig..

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