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A Randomised Non-comparative Phase II Trial of Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
Other Non-Commercial Sponsor
Peter MacCallum Cancer Centre
This is a randomised trial that is assessing whether docetaxel can be effectively delivered intermittently, based on a prostate cancer marker in the blood (mGSTP1), rather than continuously which is the current standard of care. In the Experimental Arm, participants will receive 3 cycles of docetaxel chemotherapy (75mg/m^2 every 21 days) in combination with undetectable mGSTP1 level and then will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days and docetaxel treatment will be recommenced if mGSTP1 becomes detectable again. In the Active Comparator Arm, participants will receive the standard of care docetaxel treatment of continuous docetaxel treatment.