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


Condition: Prostatic Neoplasms

Intervention:

  • Drug: Enzalutamide
  • Drug: NSAA
  • Drug: LHRHA or Surgical Castration

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02446405

Sponsor: University of Sydney

Primary Outcome Measures:

  • Measure: Overall Survival Time
  • Time Frame: 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Prostate specific antigen progression free survival time
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Clinical progression free survival time
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Adverse events
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Health-related quality of life (EORTC Core Quality of Life Questionnaire (QLQ C-30), Quality of Life Questionnaire for Prostate Cancer (PR-25), Euroqol 5 item preference-based measure of health (EQ-5 D-5L))
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Healthcare resource cost-effectiveness (incremental cost effectiveness ratio)
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 1125

Study Start Date: March 2014

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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-
  7. Patients with performance status 2 are only eligible if the decline in performance status is due to metastatic prostate cancer.
  8. Study treatment both planned and able to start within 7 days after randomisation.
  9. Willing and able to comply with all study requirements, including treatment and required assessments
  10. Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESS is unable to complete because of limited literacy or vision
  11. 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:

  • Dana Farber Cancer Institute
  • Boston Massachusetts 02115 United States
  • Chris O'Brien Lifehouse
  • Camperdown New South Wales 2050 Australia
  • Coffs Harbour Health Campus
  • Coffs Harbour New South Wales 2450 Australia
  • Concord Cancer Centre - Concord Repatriation General Hospital
  • Concord New South Wales 2139 Australia
  • St Vincent's Hospital Sydney
  • Darlinghurst New South Wales 2010 Australia
  • Nepean Cancer Care Centre
  • Kingswood New South Wales 2747 Australia
  • St. George Hospital
  • Kogarah New South Wales 2217 Australia
  • Central West Cancer Services
  • Orange New South Wales 2800 Australia
  • Port Macquarie Base Hospital
  • Port Macquarie New South Wales 2444 Australia
  • Prince of Wales Hospital
  • Randwick New South Wales 2031 Australia
  • Northern Cancer Institute
  • St Leonards New South Wales 2065 Australia
  • Tamworth Rural Referral Hospital
  • Tamworth New South Wales 2340 Australia
  • The Tweed Hospital
  • Tweed Heads New South Wales 2485 Australia
  • Riverina Cancer Care Centre
  • Wagga Wagga New South Wales 2650 Australia
  • Sydney Adventist Hospital
  • Wahroonga New South Wales 2076 Australia
  • Wollongong Hospital
  • Wollongong New South Wales 2500 Australia
  • Royal Darwin Hospital
  • Tiwi Northern Territory 0810 Australia
  • Townsville Hospital
  • Douglas Queensland 4814 Australia
  • Royal Brisbane and Women's Hospital
  • Herston Queensland 4006 Australia
  • Nambour General Hospital
  • Nambour Queensland 4560 Australia
  • Gold Coast University Hospital
  • Southport Queensland 4215 Australia
  • Princess Alexandra Hospital
  • Woolloongabba Queensland 4102 Australia
  • Royal Adelaide Hospital
  • Adelaide South Australia 5000 Australia
  • Flinders Medical Centre
  • Bedford Park South Australia 5042 Australia
  • Adelaide Cancer Centre - Ashford Cancer Care Centre
  • Kurralta Park South Australia 5037 Australia
  • Royal Hobart Hospital
  • Hobart Tasmania 7000 Australia
  • Bendigo Hospital
  • Bendigo Victoria Australia
  • Monash Cancer Centre Moorabbin
  • Bentleigh East Victoria 3165 Australia
  • Peter MacCallum Cancer Centre - East Melbourne
  • East Melbourne Victoria 3002 Australia
  • St. Vincents Hospital Melbourne
  • Fitzroy Victoria 3065 Australia
  • Peninsula South Eastern Haematology & Oncology Group- Peninsula Oncology Centre
  • Frankston Victoria 3199 Australia
  • University Hospital Geelong
  • Geelong Victoria 3220 Australia
  • Austin Hospital
  • Heidelberg Victoria 3084 Australia
  • Australian Urology Associates
  • Malvern Victoria 3144 Australia
  • Eastern Health Box Hill Hospital
  • Melbourne Victoria Australia
  • Goulburn Valley Health
  • Shepparton Victoria 3630 Australia
  • Border Medical Oncology
  • Wodonga Victoria 3690 Australia
  • Sir Charles Gairdner Hospital
  • Nedlands Western Australia 6009 Australia
  • Fiona Stanley Hospital (formerly Royal Perth Hospital)
  • Perth Western Australia 6000 Australia
  • Prostate Cancer Institute - Southern Alberta Institute of Urology
  • Calgary Alberta T2V 1P9 Canada
  • Cross Cancer Institute
  • Edmonton Alberta AB T6G 1Z2 Canada
  • BCCA - Fraser Valley Cancer Center
  • Surrey British Columbia BC V3V 1Z2 Canada
  • BCCA Vancouver Centre
  • Vancouver British Columbia V5Z 4E6 Canada
  • CancerCare Manitoba
  • Winnipeg Manitoba Canada
  • Horizon Health Network - Dr Everett Chalmers Hospital
  • Fredericton New Brunswick NB E3B 5N5 Canada
  • Saint John Regional Hospital
  • Saint John New Brunswick NB E2L 4L4 Canada
  • QEII Health Sciences Centre, Capital District Health Authority
  • Halifax Nova Scotia NS B3H 2Y9 Canada
  • Cambridge Memorial Hospital
  • Cambridge Ontario ON N1R 7S6 Canada
  • Juravinski Cancer Centre
  • Hamilton Ontario L8V 5C2 Canada
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
  • Kingston Ontario ON K7L 5P9 Canada
  • London Regional Cancer Program
  • London Ontario N6A 5W9 Canada
  • Lakeridge Health Oshawa
  • Oshawa Ontario ON L1G 2B9 Canada
  • Ottawa Hospital Cancer Centre
  • Ottawa Ontario ON K1H 8L6 Canada
  • Algoma District Cancer Program Sault Area Hospital
  • Sault Ste. Marie Ontario P6B 0A8 Canada
  • Thunder Bay Regional Health Sciences Centre
  • Thunder Bay Ontario ON P7B 6V4 Canada
  • University Health Network - Princess Margaret Hospital
  • Toronto Ontario ON M5G 2M9 Canada
  • Hôpital Notre-Dame
  • Montreal Quebec H2L 4M1 Canada
  • CHUQ-Pavillon Hotel-Dieu de Quebec
  • Québec City Quebec QC G1R 2J6 Canada
  • Allan Blair Cancer Centre
  • Regina Saskatchewan S4T 7T1 Canada
  • Saskatoon Cancer Centre
  • Saskatoon Saskatchewan S7N 4H4 Canada
  • Beaumont Hospital
  • Beaumont Dublin Dublin 9 Ireland
  • Beacon Private Hospital
  • Dublin Dublin 18 Ireland
  • Mater Misercordiae University Hospital
  • Dublin Dublin 7 Ireland
  • Mater Private Hospital
  • Dublin Dublin 7 Ireland
  • St James Hospital
  • Dublin Dublin 8 Ireland
  • St Vincent's University Hospital
  • Elm Park Dublin 4 Ireland
  • Galway University Hospital
  • Galway Ireland
  • Adelaide and Meath Hospital - National Children's Hospital
  • Tallaght Dublin 24 Ireland
  • University Hospital Waterford
  • Waterford Ireland
  • Auckland City Hospital
  • Auckland New Zealand
  • Christchurch Hospital
  • Christchurch 8140 New Zealand
  • Waikato Hospital
  • Hamilton 3204 New Zealand
  • Royal Cornwall Hospital
  • Truro Cornwall TR1 3LQ United Kingdom
  • Royal Sussex Hospital
  • Brighton East Sussex BN2 5BE United Kingdom
  • Kent and Canterbury Hospital
  • Canterbury Kent CT1 3NG United Kingdom
  • Aberdeen Royal Infirmary
  • Aberdeen Scotland AB25 2ZN United Kingdom
  • Velindre Cancer Centre
  • South Glamorgan Wales CF14 2TL United Kingdom
  • University College Hospital London
  • London NW1 2BU United Kingdom
  • Guys and St Thomas Hospital
  • London SE1 9RT United Kingdom
  • Royal Marsden Hospital
  • London SW3 6JJ United Kingdom
  • University Hospital Southampton
  • Southampton SO16 6YD United Kingdom
  • Great Western Hospital
  • Swindon SN3 6BB United Kingdom

View trial on ClinicalTrials.gov


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