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Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer (ENZAMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02446405
Recruitment Status : Active, not recruiting
First Posted : May 18, 2015
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
National Health and Medical Research Council, Australia
Cancer Trials Ireland
NCIC Clinical Trials Group
Information provided by (Responsible Party):
University of Sydney

Brief 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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Enzalutamide Drug: NSAA Drug: LHRHA or Surgical Castration Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Stratification factors:

  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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
Study Start Date : March 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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.

Drug: Enzalutamide
Drug: LHRHA or Surgical Castration
Active Comparator: 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.

Drug: NSAA
Drug: LHRHA or Surgical Castration



Primary Outcome Measures :
  1. Overall Survival Time [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Prostate specific antigen progression free survival time [ Time Frame: 3 years ]
  2. Clinical progression free survival time [ Time Frame: 3 years ]
  3. Adverse events [ Time Frame: 3 years ]
  4. 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 ]
  5. Healthcare resource cost-effectiveness (incremental cost effectiveness ratio) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446405


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02446405     History of Changes
Other Study ID Numbers: ANZUP 1304
ACTRN12614000110684 ( Other Identifier: Australian New Zealand Clinical Trials Registry (ANZCTR) )
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by University of Sydney:
metastatic prostate cancer
prostate cancer
prostate cancer treatment
enzalutamide

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs