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ACTIVE NOT RECRUITING

NCT02446405

PHASE3

Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Sponsor: University of Sydney

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.

Official title: Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1125

Start Date

2014-03

Completion Date

2027-06-30

Last Updated

2025-02-06

Healthy Volunteers

Conditions

Prostatic Neoplasms

Interventions

DRUG

Enzalutamide

DRUG

NSAA

DRUG

LHRHA or Surgical Castration

Men starting first line androgen deprivation therapy for metastatic prostate cancer. Inclusion criteria: 1. Male aged 18 or older with metastatic adenocarcinoma of the prostate 2. Target or non-target lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 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 Upper Limit of Normal (ULN) and bilirubin \< 1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be \< 5 x ULN 5. Adequate renal function: calculated creatinine clearance \> 30 ml/min (Cockcroft-Gault) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with performance status 2 are only eligible if the decline in performance status is due to metastatic prostate cancer. 7. Study treatment both planned and able to start within 7 days after randomisation. 8. Willing and able to comply with all study requirements, including treatment and required assessments 9. Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESS is unable to complete because of limited literacy or vision 10. Signed, written, informed consent Exclusion Criteria: 1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components 2. 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, ongoing arrhythmias of Grade \>2 \[National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03\], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. 3. Life expectancy of less than 12 months. 4. History of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours). 5. Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety a. Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide. 6. 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; 7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception. 8. Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings: * Started less than 12 weeks prior to randomisation AND Prostate Specific Antigen (PSA) is stable or falling. The 12 weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration. * In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg. 9. Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted. 10. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.

Locations (82)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia

Concord Cancer Centre - Concord Repatriation General Hospital

Concord, New South Wales, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Nepean Cancer Care Centre

Kingswood, New South Wales, Australia

St. George Hospital

Kogarah, New South Wales, Australia

Central West Cancer Services

Orange, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Genesis Care North Shore

St Leonards, New South Wales, Australia

Tamworth Rural Referral Hospital

Tamworth, New South Wales, Australia

The Tweed Hospital

Tweed Heads, New South Wales, Australia

Riverina Cancer Care Centre

Wagga Wagga, New South Wales, Australia

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Royal Darwin Hospital

Tiwi, Northern Territory, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Townsville Hospital

Douglas, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Adelaide Cancer Centre - Ashford Cancer Care Centre

Kurralta Park, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Bendigo Hospital

Bendigo, Victoria, Australia

Monash Cancer Centre Moorabbin

Bentleigh East, Victoria, Australia

Peter MacCallum Cancer Centre - East Melbourne

East Melbourne, Victoria, Australia

St. Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Peninsula South Eastern Haematology & Oncology Group- Peninsula Oncology Centre

Frankston, Victoria, Australia

University Hospital Geelong

Geelong, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Australian Urology Associates

Malvern, Victoria, Australia

Eastern Health Box Hill Hospital

Melbourne, Victoria, Australia

Goulburn Valley Health

Shepparton, Victoria, Australia

Border Medical Oncology

Wodonga, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Fiona Stanley Hospital (formerly Royal Perth Hospital)

Perth, Western Australia, Australia

Prostate Cancer Institute - Southern Alberta Institute of Urology

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

BCCA - Fraser Valley Cancer Center

Surrey, British Columbia, Canada

BCCA Vancouver Centre

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Horizon Health Network - Dr Everett Chalmers Hospital

Fredericton, New Brunswick, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

QEII Health Sciences Centre, Capital District Health Authority

Halifax, Nova Scotia, Canada

Cambridge Memorial Hospital

Cambridge, Ontario, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Algoma District Cancer Program Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

University Health Network - Princess Margaret Hospital

Toronto, Ontario, Canada

Hôpital Notre-Dame

Montreal, Quebec, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Beaumont Hospital

Beaumont, Dublin, Ireland

Beacon Private Hospital

Dublin, Ireland

St Vincent's University Hospital

Dublin, Ireland

Mater Misercordiae University Hospital

Dublin, Ireland

Mater Private Hospital

Dublin, Ireland

St James Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Adelaide and Meath Hospital - National Children's Hospital

Tallaght, Ireland

University Hospital Waterford

Waterford, Ireland

Auckland City Hospital

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Waikato Hospital

Hamilton, New Zealand

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Royal Sussex Hospital

Brighton, East Sussex, United Kingdom

Kent and Canterbury Hospital

Canterbury, Kent, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Velindre Cancer Centre

Cardiff, Wales, United Kingdom

University College Hospital London

London, United Kingdom

Guys and St Thomas Hospital

London, United Kingdom

Royal Marsden Hospital

London, United Kingdom

University Hospital Southampton

Southampton, United Kingdom

Great Western Hospital

Swindon, United Kingdom

Clinical Research Directory

Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (82)