ENZARAD Trial

Trial Title:

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

Trial Acronym:

ENZARAD

Protocol Number:

ANZUP 1303

Trial Design:

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

Collaborators:

ICORGTROG, Dana-Farber Cancer Institute

ANZ Study Chairs:

Scott Williams and Paul Nguyen

ANZ Coordinating Centre:

NHMRC CTC

Trial Coordinator:

Emily Tu

Trial Email:

enzarad@ctc.usyd.edu.au

Patient Population:

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

Intervention:

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) Adverse events (CTCAE v4.03)
7) Health related quality of life (EORTC QLQC-30,PR-25 & EQ-5D-5L)
8) Health outcomes relative to costs (incremental cost effectiveness ratio)

Status:

Active and Recruiting

Sites Recruiting:

NSW
• 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
• Sydney Adventist Hospital
• Tamworth Hospital
• Westmead Hospital

QLD
• 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

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

TAS
• Royal Hobart Hospital

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

WA
• Fiona Stanley Hospital 

New Zealand
• Auckland Hospital
• Christchurch Hospital

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

USA
• Beth Israel Deaconess Medical Center (BIDMC)
• Dana Farber Cancer Institute
 
UK
• 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
• Velindre Cancer Centre
• Western General Hospital


Further Information:

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