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Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
The study will compare the effectiveness of standard deprivation therapy and radiation therapy combined either with enzalutamide or with currently available antiandrogen drugs for improving the survival in men with localised prostate cancer at high risk of recurrence. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more who has been diagnosed with adenocarcinoma of the prostate, judged to be at high risk for recurrence. You must also be deemed suitable for external beam radiation therapy. Study details Participants in this study will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will be treated with 160mg Enzalutamide daily by mouth for 24 months. Participants in the other group will receive currently available anti-androgen drugs for 6 months. Anti-androgen drugs block testosterone and related androgens from attaching to molecules in the cancer cell called â€œandrogen receptors.â€ Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Participants will be regularly assessed in order to determine which of these treatments is best at improving the survival of men, as well as the ability of treatments to control prostate cancer, the safety of the treatments, the effects of the treatments on quality of life, and differences in the costs of care