Trial Title:

Enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer: a randomised phase III trial

Trial Acronym:


Protocol Number:

ANZUP 1304

Trial Design:

Open label, randomised, stratified, 2-arm, multicentre, phase 3 clinical trial


ICORG, NCIC CTG, Dana-Farber Cancer Institute

ANZ Study Chairs:

Ian Davis and Christopher Sweeney

ANZ Coordinating Centre:


Trial Coordinator:

Diana Winter

Trial Email:


Patient Population:

Men with metastatic prostate cancer commencing androgen deprivation therapy


Enzalutamide 160mg daily by mouth combined with a LHRHA or surgical castration, as first line androgen deprivation therapy.

Primary Outcome:

Overall survival (death from any cause)

Secondary Outcomes:

To determine effects on:
2) Prostate specific antigen progression free survival (PCGW2)
3) Clinical progression free survival (imaging, symptoms, signs)
4) Adverse events (CTCAE v4.03)
5) Health related quality of life (EORTC QLQ C-30, PR-25 and EQ-5D-5L)
6) Health outcomes relative to costs (incremental cost effectiveness ratio)


Closed to recruitment

Sites Recruiting:

• Central West Cancer Services
• Chris O'Brien Lifehouse
• Concord Repatriation General Hospital
• Nepean Hospital
• North Coast Cancer Institute
• Northern Cancer Institute
• Port Macquarie Base Hospital - NCCI
• Prince of Wales Hospital
• Riverina Cancer Centre
• St George Hospital
• St Vincent's Hospital Sydney
• Sydney Adventist Hospital
• Tamworth Hospital
• Tweed Hospital 
• Wollongong Hospital

• Royal Darwin Hospital

• Gold Coast Hospital
• Nambour General hospital
• Princess Alexandra Hospital Brisbane
• Royal Brisbane and Women's Hospital
• Townsville Hospital

• Ashford Cancer Centre
• Flinders Medical Center
• Royal Adelaide Hospital

• Royal Hobart Hospital

• Austin Hospital
• Australian Urology Associates
• Bendigo Health
• Border Medical Oncology
• Eastern Health
• Geelong Hospital
• Goulburn Valley Health
• Monash Cancer Center - Moorabbin
• Peninsula South Eastern Haematology & Oncology Group (PSEHOG)
• Peter MacCallum Cancer Centre - East Melbourne
• St Vincent's Hospital Melbourne

• Fiona Stanley Hospital
• Sir Charles Gairdner Hospital 

• Auckland Hospital
• Christchurch Hospital
• Waikato Hospital

• Adelaide and Meath Hospital – National Children Hospital
• Beacon Private Hospital - Dublin
• Beaumont Hospital
• Galway University Hospital
• Mater Misericordiae University Hospital
• Mater Private Hospital
• St James Hospital
• St Vincents University Hospital
• University Hospital Waterford

• Aberdeen Royal Infirmary
• BSUH (Royal Sussex Hospital)
• Great Western General Hospital
• Guy's and St. Thomas Hospital
• Kent & Canterbury Hospital
• Royal Cornwall Hospital
• St Bartholomew's Hospital
• The Royal Marsden NHS Foundation Trust
• University Hospital Southampton
• University of London Hospital
• Velindre Cancer Centre
• Dana-Farber Cancer Institute
• Algoma District Cancer Program Sault Area Hospital
• Allan Blair Cancer Centre
• BC Cancer Agency Fraser Valley
• BC Cancer Agency Vancouver Cancer Centre
• Cambridge Memorial Hospital 
• Cancer Centre of Southeastern Ontario at Kingston General Hospital
• Cancer Care Manitoba
• CHUM - Hospital Notre-Dame
• CHUQ-Pavillon Hotel-Dieu de Quebec
• Cross Cancer Institute
• Dr Everett Chalmers Hospital - Horizon Health Network
• Juravinski Cancer Centre
• Lakeridge Health Oshawa
• London Regional Cancer Program
• Ottawa Hospital Cancer Centre 
• Princess Margaret Cancer Centre
• QEII Health Sciences Centre CDHA
• Saint John Regional Hospital 
• Saskatoon Cancer Centre
• Southern Alberta Institute of Urology
• Thunder Bay Regional Health Science Centre

Further Information:

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