New drug combo aims to stop High-Risk prostate cancer from spreading

NCT ID NCT04136353

Ongoing Disease control Sponsor: University of Sydney Source: ClinicalTrials.gov ↗

First seen May 17, 2026 · Last updated May 17, 2026

Summary

This study tests whether adding darolutamide to standard hormone therapy and radiation can delay cancer spread in men with very high-risk localized prostate cancer. About 1,100 men will receive either darolutamide or a placebo alongside their usual treatment. The goal is to see if the combination improves metastasis-free survival and overall survival.

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Contacts and locations

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Locations

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom
Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada
Ashford Cancer Centre Research

Kurralta Park, South Australia, 5037, Australia
Auckland City Hospital

Auckland, 1023, New Zealand
BC Cancer Agency (BCCA) Fraser Valley

Surrey, British Columbia, V3V 1Z2, Canada
Beacon Private Hospital Dublin

Dublin, D18 AK68, Ireland
Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom
Belfast City Hospital

Belfast, BT9 7AB, United Kingdom
Bon Secours Hospital Cork in association with UPMC Hillman Centre

Cork, T23, Ireland
Border Medical Oncology Research Unit

Albury, New South Wales, 2640, Australia
Box Hill Hospital

Box Hill, Victoria, 3128, Australia
Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia
Campbelltown hospital

Sydney, New South Wales, 2560, Australia
CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada
Centre Hospitalier Regional de Trois-Rivieres

Québec, G8Z 3R9, Canada
Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada
Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada
Centre Integre de Sante et de Services Sociaux de la Monteregie Centre

Greenfield Park, Quebec, J4V 2H1, Canada
Chris O'Brien Lifehouse

Sydney, New South Wales, 2050, Australia
Christchurch Hospital

Christchurch, 8011, New Zealand
Cork University Hospital

Cork, T12 EC8P, Ireland
Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada
Dana Farber Cancer Institute - Milford

Milford, Massachusetts, 01757, United States
Dana Farber Cancer Institute - St. Elizabeth's

Brighton, Massachusetts, 02135, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dayton Physicians Network

Kettering, Ohio, 45409, United States
Dr. H. Bliss Murphy Cancer Centre, St. John's

St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Fiona Stanley Hospital

Murdoch, Western Australia, 6143, Australia
Galway University Hospital

Galway, H91 YR71, Ireland
GenesisCare Cabrini (Gandel Wing), Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia
GenesisCare Newcastle

Newcastle, New South Wales, 2290, Australia
Gosford Hospital

Gosford, New South Wales, 2250, Australia
Guy's and St Thomas Hospital

London, SE1 9RT, United Kingdom
Hôtel-Dieu de Québec

Québec, Quebec, G1R 2J6, Canada
Icon Cancer Centre

Southport, Queensland, 4215, Australia
Icon Cancer Centre Hobart

Hobart, Tasmania, 7000, Australia
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
Kent and Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom
Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada
Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States
Latrobe Regional Hospital

Traralgon, Victoria, Australia
Liverpool Hospital

Sydney, New South Wales, 2170, Australia
Mater Misericordiae University Hospital

Dublin, D07 A8NN, Ireland
Mater Private Dublin

Dublin, D07 WKW8, Ireland
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States
New Jersey Urology Saddle Brook

Clifton, New Jersey, 07013, United States
New Jersey Urology Voorhees

Voorhees Township, New Jersey, 08043, United States
New Mexico Oncology and Hematology Specialists

Albuquerque, New Mexico, 87109, United States
New York University Langone Long Island

Mineola, New York, 11501, United States
New York University Langone Medical Center

New York, New York, 10016, United States
Northern Cancer Institute

Sydney, New South Wales, 2065, Australia
Nottingham University Hospitals NHS Trust - Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom
Odette Cancer Centre - Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada
Ottawa Hospital Research Institute

Toronto, Ontario, K1H 8L6, Canada
Palmerston North Hospital

Palmerston North, 4442, New Zealand
Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia
Peter MacCallum Cancer Centre (Moorabbin Campus)

Bentleigh East, Victoria, 3165, Australia
Peter MacCallum Cancer Centre - Bendigo Campus

Bendigo, Victoria, 3550, Australia
Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia
Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia
Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada
Queen Elizabeth II Health Sciences Centre

London, Ontario, B3H 1V7, Canada
ROPART

Brisbane, Queensland, 4101, Australia
Regional Health Authority B, Zone 2 Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada
Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia
Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia
Royal Marsden Hospital

London, United Kingdom
Royal United Hospital Bath

Bath, BA1 3NG, United Kingdom
Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada
Sault Area Hospital - Algoma District Cancer Program

Sault Ste. Marie, Ontario, P6B 0A8, Canada
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Shoalhaven District Memorial Hospital

Nowra, New South Wales, 2541, Australia
Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6006, Australia
St George Hospital

Sydney, New South Wales, 2217, Australia
St Luke's Radiation Oncology Network at St James's Hospital

Dublin, D08 T6T8, Ireland
St Vincent's Public Hospital

Sydney, New South Wales, 2010, Australia
St. Luke's Hospital

Rathgar, Dublin 6, D06 E1C9, Ireland
Sunshine Hospital

St Albans, Victoria, 3021, Australia
Sydney Adventist Hospital

Sydney, New South Wales, 2076, Australia
Tallaght University Hospital

Dublin, D24 NR0A, Ireland
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
Townsville Hospital

Townsville, Queensland, 4814, Australia
Western General Hospital

Edinburgh, EH4 2XU, United Kingdom
Western Manitoba Cancer Centre - Prairie Mountain Health

Brandon, Manitoba, R7A 2B3, Canada
William Harvey Hospital

Ashford, TN24 0LZ, United Kingdom
Wollongong Hospital

Wollongong, New South Wales, 2500, Australia
XCancer Omaha/Urology Cancer Center

Omaha, Nebraska, 68130, United States

Conditions

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PROSTATE CANCER