Wednesday, December 02, 2020 The PR22 (ANZUP 1801) study DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate. A Randomized Phase III Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localized Prostate Cancer has been centrally activated in Canada. The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence. Objectives: 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 Find out more on the CCTG PR22 trial page.
