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Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
Other Non-Commercial Sponsor
University of Sydney
Eligible patients will be randomised to receive 2x300mg tablets of Darolutamide or a placebo twice daily for 96 weeks. All patients will be treated with Luteinizing Hormone-Releasing Hormone Analog (LHRHA) for 96 weeks from randomisation and commence radiation therapy within 8-24 weeks of randomisation.