Primary: Metastasis-free survival
Secondary: Overall survival; prostate cancer-specific survival; PSA-progression free surival; time to subsequent hormonal therapy; time to castration-resistance; frequency and esverity of adverse events; health-related QoL; fear of cancder recurrence Tertiary: Incremental cost-effectiveness; prognostic/predictive biomarkers The hypothesis of this study is that augmenting systemic therapy, with darolutamide for very high risk prostate cancer patients will decrease the rate of distant metastasis at 5 years. Metastasis free survival is a predictor of overall survival in very high risk prostate cancer patients. Randomised Phase III placebo-controlled, double-blind trial stratified by:
• Previous radical prostatectomy (yes or no);
• Planned use of adjuvant docetaxel (yes or no); and
• Clinical or pathological pelvic nodal involvement (yes or no)
