Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

Running, not enrolling · Phase 3

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT02446444

Run by

University of Sydney

People needed

802

Starts

2014-03-01

Expected to finish

2026-06-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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.
• 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

Where it is running

• 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
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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