Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer
NCT ID: NCT02446444
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
802 participants
INTERVENTIONAL
2014-03-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Gleason score (\<=7 versus 8-10),
* Regional lymph nodes involvement (N0 versus N1)
* Clinical T-stage (T2 and below versus T3 and above),
* PSA (\<20ng/mL versus ≥ 20ng/mL)
* Study Site
* Brachytherapy (yes versus no)
* Pelvic Field (yes versus no)
TREATMENT
NONE
Study Groups
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Enzalutamide
Enzalutamide 160 mg daily, by mouth, for 24 months from randomisation. All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
Enzalutamide
LHRHA
External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)
Conventional Non-steroidal Anti-androgen (NSAA)
Conventional Non-steroidal Anti-androgen (NSAA), by mouth, for 6 months from randomisation.
All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
Conventional NSAA
LHRHA
External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)
Interventions
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Enzalutamide
Conventional NSAA
LHRHA
External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)
Eligibility Criteria
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Inclusion Criteria
Gleason score 8-10 OR Gleason score of 4+3 AND clinical T2b-4 AND PSA \>20ng/mL OR N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or biopsy proven
2. Age ≥18 years
3. Adequate bone marrow function Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L
4. Adequate liver function: Alanine transaminase (ALT) \< 2 x ULN and bilirubin \< 1.5 x Upper Limit of Normal (ULN), (or if bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin).
5. Adequate renal function: calculated creatinine clearance \> 30 ml/min (Cockcroft-Gault)
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
7. Study treatment both planned and able to start within 7 days of randomisation.
8. Willing and able to comply with all study requirements, including treatment, and attending required assessments
9. Has completed the baseline HRQOL questionnaires UNLESS is unable to complete because of literacy or limited vision
10. Signed, written, informed consent
Exclusion Criteria
2. Involvement of lymph nodes superior to the common iliac bifurcation, and/or outside the pelvis (distant lymph nodes). Lymph node involvement is defined by histopathological confirmation, or by a short axis measurement \>10mm on standard imaging (CT or MRI, but not PET).
3. Any contraindication to external beam radiotherapy
4. History of
* seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
* loss of consciousness or transient ischemic attack within 12 months of randomization
* significant cardiovascular disease within the last 3 months: including myocardial infarction, unstable angina, congestive heart failure (NYHA grade II or greater), ongoing arrhythmias of Grade \> 2 , thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
5. Evidence of metastatic disease: minimum imaging required Computed tomography scan (CT) / Magnetic Resonance Imaging (MRI) of the abdomen and pelvis, and Whole Body Bone Scan (WBBS). If equivocal bone scan, follow-up plain films are required to show NO evidence of cancer if not covered by CT/MRI
6. PSA \> 100 ng/mL
7. History of another malignancy within 5 years prior to randomisation except for non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours).
8. Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
* Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide.
9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
10. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
11. Use of hormonal therapy or androgen deprivation therapy, including enzalutamide, except in the following setting:
* Use of LHRHA (with or without anti-androgens) for less than 30 days prior to randomisation in the trial.
12. Bilateral orchidectomy or radical prostatectomy
13. Prior brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields
14. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
15. Major surgery within 21 days prior to randomisation
16. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of enzalutamide, including difficulty swallowing tablets
18 Years
MALE
No
Sponsors
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Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
National Health and Medical Research Council, Australia
OTHER
Cancer Trials Ireland
NETWORK
Trans Tasman Radiation Oncology Group
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Scott Williams
Role: STUDY_CHAIR
ANZUP and Peter MacCallum Cancer Centre
Paul Nguyen
Role: STUDY_CHAIR
Dana Farber Cancer Institute and ANZUP
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Genesis Cancer Care Newcastle
Gateshead, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Orange Health Service
Orange, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
St Vincent's Hospital
Sydney, New South Wales, Australia
Tamworth Rural Referral Hospital
Tamworth, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Genesis Cancer Care Queensland - Wesley and Chermside
Auchenflower, Queensland, Australia
Townsville Hospital
Douglas, Queensland, Australia
Royal Brisbane & Womens Hospital
Herston, Queensland, Australia
Nambour General Hospital
Nambour, Queensland, Australia
Radiation Oncology Services Mater Centre
South Brisbane, Queensland, Australia
ICON - Gold Coast (formerly ROC Gold Coast)
Southport, Queensland, Australia
ICON - Toowoomba (formerly ROC Toowoomba)
Toowoomba, Queensland, Australia
Genesis Cancer Care Queensland - Tugun and Southport
Tugun, Queensland, Australia
Princess Alexandra Hospital Brisbane
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Ashford Cancer Centre Research (Adelaide Cancer Centre)
Kurralta Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Peter MacCallum Cancer Centre
Bendigo, Victoria, Australia
Peter MacCallum Cancer Centre (Moorabbin Campus)
Bentleigh East, Victoria, Australia
Eastern Health (Box Hill Hospital)
Box Hill, Victoria, Australia
Genesis Care - Epping (formerly EROC)
Epping, Victoria, Australia
Genesis Care - Western (formerly WROC)
Footscray, Victoria, Australia
Genesis Care - Frankston (formerly FROC)
Frankston, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Epworth HealthCare - Richmond
Richmond, Victoria, Australia
Genesis Care - Ringwood (formerly RROC)
Ringwood East, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Salzburger Landeskliniken - Universitätsklinikum Salzburg
Salzburg, , Austria
AZ Groeninge Kortrijk- Campus Kennedylaan
Kortrijk, , Belgium
Cork University Hospital
Cork, Co Cork, Ireland
Galway University Hospital
Galway, Co Galway, Ireland
Mater Misericordiae University Hospital
Dublin, Dublin 7, Ireland
Beacon Private Hospital
Dublin, , Ireland
St Luke's Hospital
Dublin, , Ireland
Mater Private Hospital
Dublin, , Ireland
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Palmerston North Hospital
Palmerston North, , New Zealand
The Institute Of Oncology
Ljubljana, , Slovenia
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Badalona, Barcelona, Spain
Hospital Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Velindre Hospital
Whitchurch, Cardiff, United Kingdom
University Hospital Southhampton
Southampton, Hampshire, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom
Royal Marsden Hospital
Chelsea, London, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Royal United Hospital Bath
Bath, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
University of London Hospital
London, , United Kingdom
Guys and St Thomas Hospital
London, , United Kingdom
Charring Cross Hospital: Imperial College Healthcare NHS Trust
London, , United Kingdom
Nottingham City Hospital- City Campus
Nottingham, , United Kingdom
Countries
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Related Links
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Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group.
University of Sydney, National Health and Medical Research Council (NHMRC) Clinical Trials Centre.
Australian New Zealand Clinical Trials Registry (ANZCTR)
Other Identifiers
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ACTRN12614000126617
Identifier Type: OTHER
Identifier Source: secondary_id
ANZUP1303
Identifier Type: -
Identifier Source: org_study_id
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