Prostate — In Follow-up

The purpose of this study is to see if a new tablet drug, darolutamide, combined with the current best treatments, can improve outcomes for people with high risk prostate cancer that has not spread beyond the prostate area. Previous studies have shown promising results for darolutamide preventing disease progression and improving survival for people with advanced prostate cancer.

DASL-HiCaP is being led internationally by ANZUP with another exciting opportunity to collaborate with our partners at the NHMRC Clinical Trials Centre, the Canadian Cancer Trials Group, Cancer Trials Ireland (Ireland and UK), and the Memorial Sloan Kettering Cancer Center and Prostate Cancer Clinical Trials Consortium in the US. The University of Sydney is the Sponsor and and the NHMRC Clinical Trials Centre is the global coordinating centre. We thank and acknowledge Bayer for providing funding and product for the DASL-HiCaP Trial.

The trial is now closed to recruitment, and enrolled 1,106 people from Australia, New Zealand, Canada, US, Ireland, and the UK.
If you think this trial might be right for you, please ask your doctor.
Trial Title
Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
Cancer Type
Trial Status
In Follow-up
Protocol Number
ANZUP 1801
Co-ordinating centre
Study Chair
Prof Christopher Sweeney and Assoc/Prof Tamim Niazi
Patient Population
People 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.
Detailed Information
Further Information
Participating Centres
Calvary Mater Newcastle
Chris O'Brien Lifehouse - Sydney Local Health District
GenesisCare Northern Cancer Institute St Leonard's
Border Medical Oncology Research Unit
Campbelltown Hospital - South Western Sydney Local Health District
GenesisCare Newcastle
Gosford Hospital
Liverpool Hospital - South Western Sydney Local Health District
Prince of Wales Hospital - South Eastern Sydney Health District
St George Hospital - South Eastern Sydney Local Health District (SESLHD)
St Vincent's Hospital - Sydney
Wollongong Hospital
Sydney Adventist Hospital

Peter MacCallum Cancer Centre
Peter MacCallum Cancer Centre - Bendigo
Peter MacCallum Cancer Centre - Moorabbin
Box Hill Hospital - Eastern Health
Alfred Health - The Alfred Hospital
Sunshine Hospital
Genesiscare Cabrini

Icon Cancer Centre - Gold Coast University Hospital
Princess Alexandra Hospital
Radiation Oncology Princess Alexandra Hospital Raymond Terrace (ROPART)
Royal Brisbane & Women's Hospital
The Townsville Hospital

Ashford Cancer Centre Research

Royal Hobart Hospital

Sir Charles Gairdner Hospital 
Fiona Stanley Hospital

Auckland City Hospital
Palmerston North Hospital
Christchurch Hospital

Bon Secours Hospital, Cork
Mater Misericordiae University Hospital
Mater Private Hospital
St. Lukes Hospital

Jewish General Hospital
Queen Elizabeth II Health Sciences Centre
Odette Cancer Centre - Sunnybrook Hospital
Ottawa Health Research Institute
Centre Hospitalier Universitaire de Sherbrooke

Memorial Sloan Kettering Cancer Center
MSKCC - Commack (Satellite site)
MSKCC - Westchester (Satellite site)
MSKCC - Monmouth (Satellite site)
MSKCC -Bergen (Satelitte site)
Dana-Farber Cancer Institute
Urology Cancer Center

Participating Centres