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Brief Title: Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer
Official Title: Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
Study ID: NCT02446405
Brief Summary: The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
Concord Cancer Centre - Concord Repatriation General Hospital, Concord, New South Wales, Australia
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Nepean Cancer Care Centre, Kingswood, New South Wales, Australia
St. George Hospital, Kogarah, New South Wales, Australia
Central West Cancer Services, Orange, New South Wales, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Genesis Care North Shore, St Leonards, New South Wales, Australia
Tamworth Rural Referral Hospital, Tamworth, New South Wales, Australia
The Tweed Hospital, Tweed Heads, New South Wales, Australia
Riverina Cancer Care Centre, Wagga Wagga, New South Wales, Australia
Sydney Adventist Hospital, Wahroonga, New South Wales, Australia
Wollongong Hospital, Wollongong, New South Wales, Australia
Royal Darwin Hospital, Tiwi, Northern Territory, Australia
Sunshine Coast University Hospital, Birtinya, Queensland, Australia
Townsville Hospital, Douglas, Queensland, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Adelaide Cancer Centre - Ashford Cancer Care Centre, Kurralta Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Bendigo Hospital, Bendigo, Victoria, Australia
Monash Cancer Centre Moorabbin, Bentleigh East, Victoria, Australia
Peter MacCallum Cancer Centre - East Melbourne, East Melbourne, Victoria, Australia
St. Vincents Hospital Melbourne, Fitzroy, Victoria, Australia
Peninsula South Eastern Haematology & Oncology Group- Peninsula Oncology Centre, Frankston, Victoria, Australia
University Hospital Geelong, Geelong, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Australian Urology Associates, Malvern, Victoria, Australia
Eastern Health Box Hill Hospital, Melbourne, Victoria, Australia
Goulburn Valley Health, Shepparton, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Fiona Stanley Hospital (formerly Royal Perth Hospital), Perth, Western Australia, Australia
Prostate Cancer Institute - Southern Alberta Institute of Urology, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA - Fraser Valley Cancer Center, Surrey, British Columbia, Canada
BCCA Vancouver Centre, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Horizon Health Network - Dr Everett Chalmers Hospital, Fredericton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
QEII Health Sciences Centre, Capital District Health Authority, Halifax, Nova Scotia, Canada
Cambridge Memorial Hospital, Cambridge, Ontario, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Algoma District Cancer Program Sault Area Hospital, Sault Ste. Marie, Ontario, Canada
Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
University Health Network - Princess Margaret Hospital, Toronto, Ontario, Canada
Hôpital Notre-Dame, Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec, Québec City, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Beaumont Hospital, Beaumont, Dublin, Ireland
Beacon Private Hospital, Dublin, , Ireland
St Vincent's University Hospital, Dublin, , Ireland
Mater Misercordiae University Hospital, Dublin, , Ireland
Mater Private Hospital, Dublin, , Ireland
St James Hospital, Dublin, , Ireland
Galway University Hospital, Galway, , Ireland
Adelaide and Meath Hospital - National Children's Hospital, Tallaght, , Ireland
University Hospital Waterford, Waterford, , Ireland
Auckland City Hospital, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
Royal Sussex Hospital, Brighton, East Sussex, United Kingdom
Kent and Canterbury Hospital, Canterbury, Kent, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Velindre Cancer Centre, Cardiff, Wales, United Kingdom
University College Hospital London, London, , United Kingdom
Guys and St Thomas Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
University Hospital Southampton, Southampton, , United Kingdom
Great Western Hospital, Swindon, , United Kingdom
Name: Christopher Sweeney
Affiliation: Dana Farber Cancer Institute and ANZUP
Role: STUDY_CHAIR
Name: Ian Davis
Affiliation: ANZUP and Eastern Health Box Hill Hospital
Role: STUDY_CHAIR