Prostate — Recruiting

The purpose of this study is to see if a new tablet drug, darolutamide, combined with the current best treatments, can improve outcomes for men 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 men with advanced prostate cancer. This is a randomised controlled trial, which means that, in addition to best standard treatments, half the participants on the study will receive darolutamide, and the other half will receive placebo. The trial is being led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. We plan to enrol 1,100 men from Australia, New Zealand, Canada, the US, Ireland, and the UK.
If you think this trial might be right for you, please ask your doctor.
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
Protocol Number
ANZUP 1801
Co-ordinating centre
Study Chair
Prof Christopher Sweeney and Assoc/Prof Tamim Niazi
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.
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 Campus
Peter MacCallum Cancer Centre (Moorabbin Campus)
Box Hill Hospital - Eastern Health

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

Fiona Stanley Hospital
Sir Charles Gairdner Hospital 

Auckland City Hospital
Palmerston North Hospital

Bon Secours Hospital, Cork

Jewish General Hospital
Queen Elizabeth II Health Sciences Centre

Memorial Sloan Kettering Cancer Center
MSKCC - Commack (Satellite site)
MSKCC - Nassau (Satellite site)
MSKCC - Basking Ridge (Satellite site)
MSKCC - Westchester (Satellite site)
MSKCC - Monmouth (Satellite site)