Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer
NCT ID: NCT02446405
Last Updated: 2025-02-06
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
1125 participants
INTERVENTIONAL
2014-03-31
2027-06-30
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
1. High volume disease (yes versus no), characterised as:
* 4 or more bone metastases, one of which is outside the vertebral column and pelvis AND/OR
* Visceral metastases (e.g. lung, pleura, liver, adrenal and others) Lymph node involvement or bladder invasion do NOT qualify as visceral disease.
2. Study site
3. Concomitant "anti-resorptive" therapy to delay skeletal related events when commencing ADT
4. Co-morbidities according to the Adult Co-morbidity Evaluation (ACE-27: 0-1 vs 2-3)
5. Early use of docetaxel defined as use of docetaxel in conjunction with initiation of ADT.
TREATMENT
NONE
Study Groups
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Enzalutamide
Enzalutamide is 160 mg daily, by mouth, until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
Enzalutamide
LHRHA or Surgical Castration
Conventional NSAA
Conventional NSAA, by mouth until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
NSAA
LHRHA or Surgical Castration
Interventions
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Enzalutamide
NSAA
LHRHA or Surgical Castration
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
Cancer Trials Ireland
NETWORK
Canadian Cancer Trials Group
NETWORK
Astellas Pharma Inc
INDUSTRY
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Christopher Sweeney
Role: STUDY_CHAIR
Dana Farber Cancer Institute and ANZUP
Ian Davis
Role: STUDY_CHAIR
ANZUP and Eastern Health Box Hill Hospital
Locations
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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
Countries
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References
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Armstrong AJ, Azad AA, Conduit C, Haas GP, Bland C, Davis ID. Enzalutamide in metastatic hormone-sensitive prostate cancer: A plain language summary of the ARCHES and ENZAMET follow-up studies. Future Oncol. 2025 Jan;21(1):15-24. doi: 10.1080/14796694.2024.2408101. Epub 2024 Oct 15.
Sweeney CJ, Martin AJ, Stockler MR, Begbie S, Cheung L, Chi KN, Chowdhury S, Frydenberg M, Horvath LG, Joshua AM, Lawrence NJ, Marx G, McCaffrey J, McDermott R, McJannett M, North SA, Parnis F, Parulekar W, Pook DW, Reaume MN, Sandhu SK, Tan A, Tan TH, Thomson A, Vera-Badillo F, Williams SG, Winter D, Yip S, Zhang AY, Zielinski RR, Davis ID; ENZAMET trial investigators and Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 Apr;24(4):323-334. doi: 10.1016/S1470-2045(23)00063-3.
Stockler MR, Martin AJ, Davis ID, Dhillon HM, Begbie SD, Chi KN, Chowdhury S, Coskinas X, Frydenberg M, Hague WE, Horvath LG, Joshua AM, Lawrence NJ, Marx GM, McCaffrey J, McDermott R, McJannett M, North SA, Parnis F, Parulekar WR, Pook DW, Reaume MN, Sandhu S, Tan A, Tan TH, Thomson A, Vera-Badillo F, Williams SG, Winter DG, Yip S, Zhang AY, Zielinski RR, Sweeney CJ; ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Health-Related Quality of Life in Metastatic, Hormone-Sensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP. J Clin Oncol. 2022 Mar 10;40(8):837-846. doi: 10.1200/JCO.21.00941. Epub 2021 Dec 20.
Davis ID, Martin AJ, Stockler MR, Begbie S, Chi KN, Chowdhury S, Coskinas X, Frydenberg M, Hague WE, Horvath LG, Joshua AM, Lawrence NJ, Marx G, McCaffrey J, McDermott R, McJannett M, North SA, Parnis F, Parulekar W, Pook DW, Reaume MN, Sandhu SK, Tan A, Tan TH, Thomson A, Tu E, Vera-Badillo F, Williams SG, Yip S, Zhang AY, Zielinski RR, Sweeney CJ; ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019 Jul 11;381(2):121-131. doi: 10.1056/NEJMoa1903835. Epub 2019 Jun 2.
Davis ID. Answering Questions and Questioning Answers: More Evidence To Guide Decision-making About Chemohormonal Therapy in Metastatic Prostate Cancer. Eur Urol. 2018 Jun;73(6):856-858. doi: 10.1016/j.eururo.2018.02.020. Epub 2018 Mar 7. No abstract available.
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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ACTRN12614000110684
Identifier Type: OTHER
Identifier Source: secondary_id
ANZUP 1304
Identifier Type: -
Identifier Source: org_study_id
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