Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Last updated: February 3, 2025
Sponsor: University of Sydney
Overall Status: Active - Not Recruiting

Phase

3

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Urologic Cancer

Treatment

LHRHA or Surgical Castration

NSAA

Enzalutamide

Clinical Study ID

NCT02446405
ANZUP 1304
ACTRN12614000110684
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 SolidTumours (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 musthave a normal conjugated bilirubin). If liver metastases are present ALT must be < 5x 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 withperformance status 2 are only eligible if the decline in performance status is dueto 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 andrequired assessments

  9. Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESSis unable to complete because of limited literacy or vision

  10. Signed, written, informed consent

Exclusion

Exclusion Criteria:

  1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine smallcell components

  2. History of

  • seizure or any condition that may predispose to seizure (e.g., prior corticalstroke or significant brain trauma).

  • loss of consciousness or transient ischemic attack within 12 months ofrandomization

  • significant cardiovascular disease within the last 3 months including:myocardial infarction, unstable angina, congestive heart failure, ongoingarrhythmias of Grade >2 [National Cancer Institute Common Terminology Criteriafor Adverse Events (CTCAE), version 4.03], thromboembolic events (e.g., deepvein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation onstable anticoagulant therapy is allowed.

  1. Life expectancy of less than 12 months.

  2. History of another malignancy within 5 years prior to randomisation, except foreither non- melanomatous carcinoma of the skin or, adequately treated,non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1tumours).

  3. Concurrent illness, including severe infection that might jeopardize the ability ofthe patient to undergo the procedures outlined in this protocol with reasonablesafety a. Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if itis controlled with anti-retroviral drugs that are unaffected by concomitantenzalutamide.

  4. Presence of any psychological, familial, sociological or geographical conditionpotentially hampering compliance with the study protocol and follow-up schedule,including alcohol dependence or drug abuse;

  5. Patients who are sexually active and not willing/able to use medically acceptableforms of barrier contraception.

  6. Prior ADT for prostate cancer (including bilateral orchidectomy), except in thefollowing 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 followingoccurs earliest: first dose of oral anti- androgen, LHRHA, or surgicalcastration.

  • In the adjuvant setting, where the completion of adjuvant hormonal therapy wasmore than 12 months prior to randomisation AND the total duration of hormonaltreatment did not exceed 24 months. For depot preparations, hormonal therapy isdeemed to have started with the first dose and to have been completed when thenext dose would otherwise have been due, e.g. 12 weeks after the last dose ofdepot goserelin 10.8mg.

  1. Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxelchemotherapy for metastatic disease is permitted.

  2. Participation in other clinical trials of investigational agents for the treatmentof prostate cancer or other diseases.

Study Design

Total Participants: 1125
Treatment Group(s): 3
Primary Treatment: LHRHA or Surgical Castration
Phase: 3
Study Start date:
March 01, 2014
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • Concord Cancer Centre - Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Nepean Cancer Care Centre

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • St. George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Central West Cancer Services

    Orange, New South Wales 2800
    Australia

    Site Not Available

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales 2444
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Genesis Care North Shore

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Tamworth Rural Referral Hospital

    Tamworth, New South Wales 2340
    Australia

    Site Not Available

  • The Tweed Hospital

    Tweed Heads, New South Wales 2485
    Australia

    Site Not Available

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales 2650
    Australia

    Site Not Available

  • Sydney Adventist Hospital

    Wahroonga, New South Wales 2076
    Australia

    Site Not Available

  • Wollongong Hospital

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Royal Darwin Hospital

    Tiwi, Northern Territory 0810
    Australia

    Site Not Available

  • Sunshine Coast University Hospital

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • Townsville Hospital

    Douglas, Queensland 4814
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4006
    Australia

    Site Not Available

  • Nambour General Hospital

    Nambour, Queensland 4560
    Australia

    Site Not Available

  • Gold Coast University Hospital

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Adelaide Cancer Centre - Ashford Cancer Care Centre

    Kurralta Park, South Australia 5037
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Bendigo Hospital

    Bendigo, Victoria
    Australia

    Site Not Available

  • Monash Cancer Centre Moorabbin

    Bentleigh East, Victoria 3165
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre - East Melbourne

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • St. Vincents Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Peninsula South Eastern Haematology & Oncology Group- Peninsula Oncology Centre

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • University Hospital Geelong

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Australian Urology Associates

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Eastern Health Box Hill Hospital

    Melbourne, Victoria
    Australia

    Site Not Available

  • Goulburn Valley Health

    Shepparton, Victoria 3630
    Australia

    Site Not Available

  • Border Medical Oncology

    Wodonga, Victoria 3690
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Fiona Stanley Hospital (formerly Royal Perth Hospital)

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Prostate Cancer Institute - Southern Alberta Institute of Urology

    Calgary, Alberta T2V 1P9
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta AB T6G 1Z2
    Canada

    Site Not Available

  • BCCA - Fraser Valley Cancer Center

    Surrey, British Columbia BC V3V 1Z2
    Canada

    Site Not Available

  • BCCA Vancouver Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Horizon Health Network - Dr Everett Chalmers Hospital

    Fredericton, New Brunswick NB E3B 5N5
    Canada

    Site Not Available

  • Saint John Regional Hospital

    Saint John, New Brunswick NB E2L 4L4
    Canada

    Site Not Available

  • QEII Health Sciences Centre, Capital District Health Authority

    Halifax, Nova Scotia NS B3H 2Y9
    Canada

    Site Not Available

  • Cambridge Memorial Hospital

    Cambridge, Ontario ON N1R 7S6
    Canada

    Site Not Available

  • Juravinski Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario ON K7L 5P9
    Canada

    Site Not Available

  • London Regional Cancer Program

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Lakeridge Health Oshawa

    Oshawa, Ontario ON L1G 2B9
    Canada

    Site Not Available

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario ON K1H 8L6
    Canada

    Site Not Available

  • Algoma District Cancer Program Sault Area Hospital

    Sault Ste. Marie, Ontario P6B 0A8
    Canada

    Site Not Available

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario ON P7B 6V4
    Canada

    Site Not Available

  • University Health Network - Princess Margaret Hospital

    Toronto, Ontario ON M5G 2M9
    Canada

    Site Not Available

  • Hôpital Notre-Dame

    Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

  • CHUQ-Pavillon Hotel-Dieu de Quebec

    Québec City, Quebec QC G1R 2J6
    Canada

    Site Not Available

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan S7N 4H4
    Canada

    Site Not Available

  • Beaumont Hospital

    Beaumont, Dublin Dublin 9
    Ireland

    Site Not Available

  • Beacon Private Hospital

    Dublin, Dublin 18
    Ireland

    Site Not Available

  • Mater Misercordiae University Hospital

    Dublin, Dublin 7
    Ireland

    Site Not Available

  • Mater Private Hospital

    Dublin, Dublin 7
    Ireland

    Site Not Available

  • St James Hospital

    Dublin, Dublin 8
    Ireland

    Site Not Available

  • St Vincent's University Hospital

    Dublin, Dublin 4
    Ireland

    Site Not Available

  • St Vincent's University Hospital

    Elm Park, Dublin 4
    Ireland

    Site Not Available

  • Galway University Hospital

    Galway,
    Ireland

    Site Not Available

  • Adelaide and Meath Hospital - National Children's Hospital

    Tallaght, Dublin 24
    Ireland

    Site Not Available

  • University Hospital Waterford

    Waterford,
    Ireland

    Site Not Available

  • Auckland City Hospital

    Auckland,
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, 8140
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3204
    New Zealand

    Site Not Available

  • Royal Cornwall Hospital

    Truro, Cornwall TR1 3LQ
    United Kingdom

    Site Not Available

  • Royal Sussex Hospital

    Brighton, East Sussex BN2 5BE
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, Kent CT1 3NG
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland AB25 2ZN
    United Kingdom

    Site Not Available

  • Velindre Cancer Centre

    Cardiff, Wales CF14 2TL
    United Kingdom

    Site Not Available

  • Velindre Cancer Centre

    South Glamorgan, Wales CF14 2TL
    United Kingdom

    Site Not Available

  • Guys and St Thomas Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • University College Hospital London

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • University Hospital Southampton

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Great Western Hospital

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

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