Prostate Cancer Clinical Trial
Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer
The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.
Men with localised prostate cancer at high risk for recurrence deemed suitable for external beam radiation therapy.
Pathological diagnosis of adenocarcinoma of the prostate, judged to be at high risk for recurrence based on any of the following (in accordance with the International Society of Urological Pathology (ISUP) Consensus 2005:
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
Age ≥18 years
Adequate bone marrow function Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L
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).
Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Study treatment both planned and able to start within 7 days of randomisation.
Willing and able to comply with all study requirements, including treatment, and attending required assessments
Has completed the baseline HRQOL questionnaires UNLESS is unable to complete because of literacy or limited vision
Signed, written, informed consent
Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
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).
Any contraindication to external beam radiotherapy
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.
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
PSA > 100 ng/mL
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).
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.
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;
Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
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.
Bilateral orchidectomy or radical prostatectomy
Prior brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields
Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
Major surgery within 21 days prior to randomisation
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of enzalutamide, including difficulty swallowing tablets
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There are 63 Locations for this study
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Blacktown New South Wales, 2148, Australia
Campbelltown New South Wales, 2560, Australia
Camperdown New South Wales, 2050, Australia
Gateshead New South Wales, 2290, Australia
Gosford New South Wales, 2250, Australia
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
Orange New South Wales, 2800, Australia
Randwick New South Wales, 2131, Australia
St Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2010, Australia
Tamworth New South Wales, 2340, Australia
Wahroonga New South Wales, 2076, Australia
Waratah New South Wales, 2298, Australia
Westmead New South Wales, 2145, Australia
Wollongong New South Wales, 2500, Australia
Auchenflower Queensland, 4066, Australia
Douglas Queensland, 4814, Australia
Herston Queensland, 4006, Australia
Nambour Queensland, 4560, Australia
South Brisbane Queensland, 4101, Australia
Southport Queensland, 4215, Australia
Toowoomba Queensland, 4350, Australia
Tugun Queensland, 4224, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Bedford Park South Australia, 5042, Australia
Kurralta Park South Australia, 5037, Australia
Hobart Tasmania, 7000, Australia
Bendigo Victoria, 3550, Australia
Bentleigh East Victoria, 3165, Australia
Box Hill Victoria, 3128, Australia
Epping Victoria, 3076, Australia
Footscray Victoria, 3011, Australia
Frankston Victoria, 3199, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3002, Australia
Richmond Victoria, 3121, Australia
Ringwood East Victoria, 3135, Australia
St Albans Victoria, 3021, Australia
Murdoch Western Australia, 6149, Australia
Salzburg , 5020, Austria
Kortrijk , 8500, Belgium
Cork Co Cork, , Ireland
Galway Co Galway, , Ireland
Dublin Dublin 7, Dubli, Ireland
Dublin , Dubli, Ireland
Dublin , Dubli, Ireland
Dublin , Dubli, Ireland
Auckland , 1142, New Zealand
Christchurch , 4170, New Zealand
Palmerston North , 4442, New Zealand
Ljubljana , 1000, Slovenia
Badalona Barcelona, 08916, Spain
Donostia Gipuzkoa, 20014, Spain
Salamanca , 37007, Spain
Whitchurch Cardiff, CF14 , United Kingdom
Southampton Hampshire, SO16 , United Kingdom
Canterbury Kent, CT1 3, United Kingdom
Chelsea London, SW3 6, United Kingdom
Edinburgh Scotland, EH4 2, United Kingdom
Bath , BA1 3, United Kingdom
Cambridge , , United Kingdom
London , NW1 2, United Kingdom
London , SE1 9, United Kingdom
London , W6 8R, United Kingdom
Nottingham , NG5 1, United Kingdom
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