Randomised Phase 3 Trial Of Enzalutamide In Androgen Deprivation Therapy (Adt) With Radiation Therapy For Clinically Localised High-Risk Or Node-Positive Prostate Cancer: Enzarad (Anzup 1303).

TPS5086Background: Adjuvant ADT with an LHRH analog (LHRHA) given before during and after radiotherapy (RT) is standard of care for high risk localised prostate cancer (PC). Enzalutamide is more effective in metastatic disease than conventional non-steroidal anti-androgens (NSAA). We hypothesize that addition of enzalutamide to adjuvant ADT and RT will improve outcomes. Aim: To determine the efficacy of enzalutamide as part of adjuvant ADT with LHRHA in men planned for RT for localized high risk or node-positive PC. Methods: Open label, randomised, stratified, 2-arm multicentre, phase 3 clinical trial. Primary endpoint: OS. Secondary endpoints: cause-specific survival, PSA PFS, clinical PFS, time to subsequent hormonal therapy, time to castration-resistant disease (PCWG2 criteria), metastasis free survival, adverse events and HRQOL. Tertiary objectives: identification of prognostic/predictive biomarkers from archival tumour tissue and serial fasting blood. Treatment is LHRHA for 24 months and radiotherapy...