Trial Identifiers
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Scientific Title
ANZadapt: Phase II Randomised Controlled Trial of Patient-specific Adaptive Versus Continuous Abiraterone or eNZalutamide in Metastatic Castration-resistant Prostate Cancer
Cooperative Group
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
Other Non-Commercial Sponsor
Leiden University Medical Center
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will start taking abiraterone or enzalutamide (AA/ENZ) daily. Each participant's prostate-specific antigen (PSA) levels will be tested monthly and once PSA has dropped to >50% they will stop treatment. The treatment will remain paused until PSA levels have risen again above the pre-treatment baseline. Once PSA levels decline >50% again, treatment will again be paused. This cycle will continue until criteria for treatment failure have been met.
In the Active Comparator Arm, participants will receive standard continuous treatment with abiraterone or enzalutamide (AA/ENZ) daily until criteria for treatment failure are met.