Trial Title:

Enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer: a randomised phase III trial

Trial Acronym:


Protocol Number:

ANZUP 1303

Trial Design:

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


ICORGTROG, Dana-Farber Cancer Institute

ANZ Study Chairs:

Scott Williams and Paul Nguyen

ANZ Coordinating Centre:


Trial Coordinator:

Diana Winter

Trial Email:


Patient Population:

The target population is men with localised prostate cancer at high risk for recurrence deemed suitable for external beam radiation therapy


Enzalutamide 160mg daily by mouth combined with LHRHA and external beam radiation therapy

Primary Outcome:

Overall survival (death from any cause)

Secondary Outcomes:

To determine effects on:
2) Cause-specific survival (prostate cancer, and other causes)
3) PSA progression free survival (Phoenix criteria)
4) Clinical progression free survival
5) Time to subsequent hormonal therapy (restarting ADT)
6) Time to castration-resistant disease (PCWG2 criteria)
7) Metastasis-free survival (MFS)
8) Adverse events (CTCAE v4.03)
9) Health related quality of life (EORTC QLQC-30, PR-25 & EQ-5D-5L)
10)  Health outcomes relative to costs (incremental cost effectiveness ratio)


Closed to recruitment

Sites Recruiting:

• Blacktown Hospital
• Calvary Mater Newcastle
• Campbelltown Hospital
• Central West Cancer Services
• Chris O'Brien Lifehouse
• Genesis Cancer Care - Newcastle
• Gosford Hospital
• Liverpool hospital
• Prince of Wales Hospital
• Royal North Shore Hospital
• St George Hospital
• St Vincent's Hospital - Sydney
• Sydney Adventist Hospital
• Tamworth Hospital
• Westmead Hospital
• Wollongong Hospital

• Genesis Cancer Care QLD - Tugun and Southport
• Genesis Cancer Care QLD - Wesley and Chermside
• Nambour General Hospital
• Oncology Research Australia, Toowoomba Hospital
• Princess Alexandra Hospital Brisbane
• Radiation Oncology Centre - Gold Coast
• Radiation Oncology Services - Mater Adult Hospital
• Royal Brisbane & Womens hospital
• Townsville Hospital

• Ashford Care Research (Adelaide Radiotherapy Centre)
• Flinders Medical Center and RGH
• Royal Adelaide Hospital

• Royal Hobart Hospital

• Austin Hospital
• Eastern Health
• Epping Radiation Oncology Centre
• Epworth Healthcare - Richmond
• Frankston Radiation Oncology Centre
• Peter MacCallum Cancer Centre (Bendigo)
• Peter MacCallum Cancer Centre (East Melbourne)
• Peter MacCallum Cancer Centre (Moorabbin Campus)
• Ringwood Radiation Oncology Centre
• Sunshine Hospital
• Western Radiation Oncology Centre Footscray

• Fiona Stanley Hospital 

New Zealand
• Auckland Hospital
• Christchurch Hospital
• Palmerston North Hospital

• Beacon Private Hospital Dublin
• Cork University Hospital
• Galway University Hospital
• Mater Misericordiae University Hospital
• Mater Private Hospital
• St. Lukes Hospital

• Beth Israel Deaconess Medical Center (BIDMC)
• Dana Farber Cancer Institute
• Addenbrookes Hospital
• Charing Cross Hospital
• Guys and St Thomas Hospital
• Kent & Canterbury Hospital
• Nottingham City Hospital - City Campus
• Royal Marsden Hospital
• Royal United Hospital Bath
• University Hospital Southampton
• University of London Hospital 
 Velindre Cancer Centre
• Western General Hospital

• University Hospital (Landeskliniken) Salzburg
• AZ Groeninge Kortrijk - Campus Kennedylaan
• The Institute of Oncology Ljubljan

• Catalan Institute of Oncology (ICO) Badalona
Hospital Universitario de Salamanca
• Hospital Donostia  

Further Information:

Click here

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