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, CTICCTG

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

Further Information:

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