DASL-HiCaP Trial

Trial Title:	Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
Trial Acronym:	DASL-HiCaP
Protocol Number:	ANZUP 1801
Trial Design:	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.
Collaborators:	PCCTC, CTI, CCTG
ANZ Study Chairs:	Christopher Sweeney and Tamim Niazi
ANZ Coordinating Centre:	NHMRC CTC
Trial Coordinator:	Jason Todd
Trial Email:	dasl@ctc.usyd.edu.au
Patient Population:	Men aged 18 years or older with either very high-risk localised prostate cancer, or very high risk features with PSA persistence or rise within one year following radical prostatectomy, suitable for RT.
Intervention:	Darolutamide 600 mg twice daily for 96 weeks or Placebo twice daily for 96 weeks.
Primary Outcome:	Metastasis-free survival (metastasis or death from any cause).
Secondary Outcomes:	2. Overall survival (death from any cause) 3. Prostate cancer-specific survival 4. PSA-progression free survival 5. Time to subsequent hormonal therapy (restart or change to treat recurrence/progression) 6. Time to castration-resistance (PCWG3 criteria) 7. Frequency and severity of adverse events (CTCAE v5.0) 8. Health related quality of life (EORTC QLQ-C30, QLQ-PR25, EQ-5D-5L) 9. Fear of cancer recurrence (FCRI)
Status:	Active and recruiting.
Sites Recruiting:	AUSTRALIA NSW Border Medical Oncology Calvary Mater Newcastle Campbelltown Hospital Chris O’Brien Lifehouse GenesisCare Newcastle GenesisCare Northern Cancer Institute Gosford Hospital Liverpool Hospital Prince of Wales Hospital St George Hospital St Vincent's Hospital VIC Peter MacCallum Cancer Centre Peter MacCallum Cancer Centre (Bendigo Campus) Peter MacCallum Cancer Centre (Moorabbin Campus) QLD Icon Cancer Centre-Gold Coast University Hospital Princess Alexandra Hospital Radiation Oncology Princess Alexandra Hospital Raymond Terrace Royal Brisbane and Women’s Hospital Townsville Hospital SA Ashford Cancer Centre Research WA Fiona Stanley Hospital TAS Royal Hobart Hospital NEW ZEALAND Auckland City Hospital
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