Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Official Title

DASL-HiCaP: 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

Summary:

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.

Trial Description

Primary Outcome:

• Metastasis-free survival

• Overall survival
• Prostate cancer-specific survival
• PSA-progression free survival
• Time to subsequent hormonal therapy
• Time to castration-resistance
• Frequency and severity of adverse events (CTCAE v5.0, RTOG/EORTC acute/late radiation morbidity criteria)
• Health-related quality of life
• Health-related quality of life
• Health-related quality of life
• Fear of cancer recurrence

View this trial on ClinicalTrials.gov