Spots Global Cancer Trial Database for Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
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Trial Identification
Brief Title: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
Official Title: DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): 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
Study ID: NCT04136353
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.
Detailed Description: This trial aims to demonstrate that the use of darolutamide (in addition to standard of care) will be more effective than current standard of care in enhancing the ability of prostate or prostate bed radiation and 96 weeks of androgen suppression in decreasing the number of patients who develop metastases and subsequently die of prostate cancer. Darolutamide is a novel antagonist of the AR with favourable tolerability due to negligible penetration of the blood-brain barrier. Emergence of metastatic disease is the lethal event after local therapy, either with prostatectomy or definitive radiation. Augmenting adjuvant systemic therapy (either ADT or ADT plus docetaxel) with darolutamide has the potential to eradicate micrometastatic disease after either type of local therapy and decrease the death rate from prostate cancer. This pragmatic design incorporates current standard of care for all patients and the option for docetaxel to be added to ADT. As such, the data will be applicable for all patients with very high risk prostate cancer treated with local therapy and will be the first study incorporating docetaxel use as one of the standard of care options. Even if docetaxel is definitively proven to improve MFS and OS in the adjuvant setting, not all patients will be fit for docetaxel. This will be the first trial that has the potential to build upon current and future advances that may emerge and be the most effective strategy to decrease death rate from prostate cancer in the near term if it further augments docetaxel efficacy in chemo-fit patients.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Dana Farber Cancer Institute - St. Elizabeth's, Brighton, Massachusetts, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
Dana Farber Cancer Institute - Milford, Milford, Massachusetts, United States
XCancer Omaha/Urology Cancer Center, Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
New Jersey Urology Saddle Brook, Clifton, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
New Jersey Urology Voorhees, Voorhees, New Jersey, United States
New Mexico Oncology and Hematology Specialists, Albuquerque, New Mexico, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
New York University Langone Long Island, Mineola, New York, United States
New York University Langone Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Dayton Physicians Network, Kettering, Ohio, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
Gosford Hospital, Gosford, New South Wales, Australia
GenesisCare Newcastle, Newcastle, New South Wales, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Shoalhaven District Memorial Hospital, Nowra, New South Wales, Australia
St Vincent's Public Hospital, Sydney, New South Wales, Australia
Prince of Wales Hospital, Sydney, New South Wales, Australia
Chris O'Brien Lifehouse, Sydney, New South Wales, Australia
Northern Cancer Institute, Sydney, New South Wales, Australia
Sydney Adventist Hospital, Sydney, New South Wales, Australia
Liverpool Hospital, Sydney, New South Wales, Australia
St George Hospital, Sydney, New South Wales, Australia
Campbelltown hospital, Sydney, New South Wales, Australia
Wollongong Hospital, Wollongong, New South Wales, Australia
ROPART, Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Icon Cancer Centre, Southport, Queensland, Australia
Townsville Hospital, Townsville, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Icon Cancer Centre Hobart, Hobart, Tasmania, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Peter MacCallum Cancer Centre - Bendigo Campus, Bendigo, Victoria, Australia
Peter MacCallum Cancer Centre (Moorabbin Campus), Bentleigh East, Victoria, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
GenesisCare Cabrini (Gandel Wing), Cabrini Hospital Malvern, Malvern, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
Latrobe Regional Hospital, Traralgon, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Agency (BCCA) Fraser Valley, Surrey, British Columbia, Canada
Western Manitoba Cancer Centre - Prairie Mountain Health, Brandon, Manitoba, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Regional Health Authority B, Zone 2 Saint John Regional Hospital, Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's, St. John's, Newfoundland and Labrador, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
Queen Elizabeth II Health Sciences Centre, London, Ontario, Canada
Sault Area Hospital - Algoma District Cancer Program, Sault Ste Marie, Ontario, Canada
Ottawa Hospital Research Institute, Toronto, Ontario, Canada
Odette Cancer Centre - Sunnybrook Hospital, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Integre de Sante et de Services Sociaux de la Monteregie Centre, Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Jewish General Hospital, Montréal, Quebec, Canada
Hôtel-Dieu de Québec, Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Regional de Trois-Rivieres, Quebec, , Canada
St. Luke's Hospital, Rathgar, Dublin 6, Ireland
Cork University Hospital, Cork, , Ireland
Bon Secours Hospital Cork in association with UPMC Hillman Centre, Cork, , Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
Mater Private Dublin, Dublin, , Ireland
St Luke's Radiation Oncology Network at St James's Hospital, Dublin, , Ireland
Beacon Private Hospital Dublin, Dublin, , Ireland
Tallaght University Hospital, Dublin, , Ireland
Galway University Hospital, Galway, , Ireland
Auckland City Hospital, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Palmerston North Hospital, Palmerston North, , New Zealand
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
William Harvey Hospital, Ashford, , United Kingdom
Royal United Hospital Bath, Bath, , United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
Kent and Canterbury Hospital, Canterbury, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Guy's and St Thomas Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital, Nottingham, , United Kingdom
Contact Details
Name: Christopher Sweeney
Affiliation: Dana-Farber Cancer Institute and Harvard Medical School
Role: STUDY_CHAIR
Name: Tamim Niazi
Affiliation: Jewish General Hospital and McGill University
Role: STUDY_CHAIR
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