1,100
Participants
Start Date
March 31, 2020
Primary Completion Date
January 31, 2028
Study Completion Date
July 31, 2028
Darolutamide
2 x 300mg oral tablets twice daily for 96 weeks
Placebo oral tablet
2 oral tablets twice daily for 96 weeks
Luteinizing Hormone-Releasing Hormone Analog
All participants are to receive standard background therapy with an LHRHA, as per standard of care. The choice of LHRHA is at the discretion of the treating clinician.
External Beam Radiotherapy
All participants are to receive standard background therapy with curative-intent RT to the prostate or prostate bed as well as the pelvic lymph nodes using EBRT.
Auckland City Hospital, Auckland
St Vincent's Public Hospital, Sydney
Prince of Wales Hospital, Sydney
Chris O'Brien Lifehouse, Sydney
Northern Cancer Institute, Sydney
Sydney Adventist Hospital, Sydney
Liverpool Hospital, Sydney
St George Hospital, Sydney
Gosford Hospital, Gosford
GenesisCare Newcastle, Newcastle
Calvary Mater Newcastle, Newcastle
Wollongong Hospital, Wollongong
Shoalhaven District Memorial Hospital, Nowra
Campbelltown hospital, Sydney
Border Medical Oncology Research Unit, Albury
Peter MacCallum Cancer Centre, Melbourne
The Alfred Hospital, Melbourne
Sunshine Hospital, St Albans
Box Hill Hospital, Box Hill
GenesisCare Cabrini (Gandel Wing), Cabrini Hospital Malvern, Malvern
Peter MacCallum Cancer Centre (Moorabbin Campus), Bentleigh East
Peter MacCallum Cancer Centre - Bendigo Campus, Bendigo
Royal Brisbane and Women's Hospital, Herston
ROPART, Brisbane
Princess Alexandra Hospital, Woolloongabba
Icon Cancer Centre, Southport
Palmerston North Hospital, Palmerston North
Townsville Hospital, Townsville
Ashford Cancer Centre Research, Kurralta Park
Sir Charles Gairdner Hospital, Nedlands
Fiona Stanley Hospital, Murdoch
Icon Cancer Centre Hobart, Hobart
Royal Hobart Hospital, Hobart
Christchurch Hospital, Christchurch
New York University Langone Medical Center, New York
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Westchester, Harrison
New York University Langone Long Island, Mineola
Memorial Sloan Kettering Nassau, Uniondale
Memorial Sloan Kettering Commack, Commack
Dayton Physicians Network, Kettering
XCancer Omaha/Urology Cancer Center, Omaha
New Mexico Oncology and Hematology Specialists, Albuquerque
Seattle Cancer Care Alliance, Seattle
Dana-Farber Cancer Institute, Boston
Dana Farber Cancer Institute - St. Elizabeth's, Brighton
Lahey Hospital and Medical Center, Burlington
Dana Farber Cancer Institute - Milford, Milford
Memorial Sloan Kettering Basking Ridge, Basking Ridge
New Jersey Urology Saddle Brook, Clifton
Memorial Sloan Kettering Monmouth, Middletown
Memorial Sloan Kettering Bergen, Montvale
New Jersey Urology Voorhees, Voorhees Township
Latrobe Regional Hospital, Traralgon
Centre Hospitalier de l'Universite de Montreal, Montreal
Royal Marsden Hospital, London
Cross Cancer Institute, Edmonton
BC Cancer Agency (BCCA) Fraser Valley, Surrey
Western Manitoba Cancer Centre - Prairie Mountain Health, Brandon
CancerCare Manitoba, Winnipeg
Regional Health Authority B, Zone 2 Saint John Regional Hospital, Saint John
Dr. H. Bliss Murphy Cancer Centre, St. John's, St. John's
Kingston Health Sciences Centre, Kingston
Queen Elizabeth II Health Sciences Centre, London
Sault Area Hospital - Algoma District Cancer Program, Sault Ste. Marie
Ottawa Hospital Research Institute, Toronto
Odette Cancer Centre - Sunnybrook Hospital, Toronto
Princess Margaret Cancer Centre, Toronto
Centre Integre de Sante et de Services Sociaux de la Monteregie Centre, Greenfield Park
Jewish General Hospital, Montreal
Hôtel-Dieu de Québec, Québec
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke
Allan Blair Cancer Centre, Regina
Saskatoon Cancer Centre, Saskatoon
Centre Hospitalier Regional de Trois-Rivieres, Québec
St. Luke's Hospital, Rathgar
Cork University Hospital, Cork
Bon Secours Hospital Cork in association with UPMC Hillman Centre, Cork
Mater Misericordiae University Hospital, Dublin
Mater Private Dublin, Dublin
St Luke's Radiation Oncology Network at St James's Hospital, Dublin
Beacon Private Hospital Dublin, Dublin
Tallaght University Hospital, Dublin
Galway University Hospital, Galway
Aberdeen Royal Infirmary, Aberdeen
William Harvey Hospital, Ashford
Royal United Hospital Bath, Bath
Belfast City Hospital, Belfast
Kent and Canterbury Hospital, Canterbury
Western General Hospital, Edinburgh
Beatson West of Scotland Cancer Centre, Glasgow
Guy's and St Thomas Hospital, London
Nottingham University Hospitals NHS Trust - Nottingham City Hospital, Nottingham
Collaborators (1)
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
Bayer
INDUSTRY
Cancer Trials Ireland
NETWORK
Canadian Cancer Trials Group
NETWORK
Memorial Sloan Kettering Cancer Center
OTHER
Prostate Cancer Clinical Trials Consortium
OTHER
University of Sydney
OTHER