Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Disorders
Urologic Cancer
Treatment
LHRHA or Surgical Castration
NSAA
Enzalutamide
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Men starting first line androgen deprivation therapy for metastatic prostate cancer.
Inclusion criteria:
Male aged 18 or older with metastatic adenocarcinoma of the prostate
Target or non-target lesions according to Response Evaluation Criteria in SolidTumours (RECIST) 1.1
Adequate bone marrow function: Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L.
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
Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)
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.
Study treatment both planned and able to start within 7 days after randomisation.
Willing and able to comply with all study requirements, including treatment andrequired assessments
Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESSis unable to complete because of limited literacy or vision
Signed, written, informed consent
Exclusion
Exclusion Criteria:
Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine smallcell components
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.
Life expectancy of less than 12 months.
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).
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.
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;
Patients who are sexually active and not willing/able to use medically acceptableforms of barrier contraception.
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.
Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxelchemotherapy for metastatic disease is permitted.
Participation in other clinical trials of investigational agents for the treatmentof prostate cancer or other diseases.
Study Design
Connect with a study center
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
AustraliaSite Not Available
Coffs Harbour Health Campus
Coffs Harbour, New South Wales 2450
AustraliaSite Not Available
Concord Cancer Centre - Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaSite Not Available
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Nepean Cancer Care Centre
Kingswood, New South Wales 2747
AustraliaSite Not Available
St. George Hospital
Kogarah, New South Wales 2217
AustraliaSite Not Available
Central West Cancer Services
Orange, New South Wales 2800
AustraliaSite Not Available
Port Macquarie Base Hospital
Port Macquarie, New South Wales 2444
AustraliaSite Not Available
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
Genesis Care North Shore
St Leonards, New South Wales 2065
AustraliaSite Not Available
Tamworth Rural Referral Hospital
Tamworth, New South Wales 2340
AustraliaSite Not Available
The Tweed Hospital
Tweed Heads, New South Wales 2485
AustraliaSite Not Available
Riverina Cancer Care Centre
Wagga Wagga, New South Wales 2650
AustraliaSite Not Available
Sydney Adventist Hospital
Wahroonga, New South Wales 2076
AustraliaSite Not Available
Wollongong Hospital
Wollongong, New South Wales 2500
AustraliaSite Not Available
Royal Darwin Hospital
Tiwi, Northern Territory 0810
AustraliaSite Not Available
Sunshine Coast University Hospital
Birtinya, Queensland 4575
AustraliaSite Not Available
Townsville Hospital
Douglas, Queensland 4814
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Herston, Queensland 4006
AustraliaSite Not Available
Nambour General Hospital
Nambour, Queensland 4560
AustraliaSite Not Available
Gold Coast University Hospital
Southport, Queensland 4215
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, South Australia 5042
AustraliaSite Not Available
Adelaide Cancer Centre - Ashford Cancer Care Centre
Kurralta Park, South Australia 5037
AustraliaSite Not Available
Royal Hobart Hospital
Hobart, Tasmania 7000
AustraliaSite Not Available
Bendigo Hospital
Bendigo, Victoria
AustraliaSite Not Available
Monash Cancer Centre Moorabbin
Bentleigh East, Victoria 3165
AustraliaSite Not Available
Peter MacCallum Cancer Centre - East Melbourne
East Melbourne, Victoria 3002
AustraliaSite Not Available
St. Vincents Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaSite Not Available
Peninsula South Eastern Haematology & Oncology Group- Peninsula Oncology Centre
Frankston, Victoria 3199
AustraliaSite Not Available
University Hospital Geelong
Geelong, Victoria 3220
AustraliaSite Not Available
Austin Hospital
Heidelberg, Victoria 3084
AustraliaSite Not Available
Australian Urology Associates
Malvern, Victoria 3144
AustraliaSite Not Available
Eastern Health Box Hill Hospital
Melbourne, Victoria
AustraliaSite Not Available
Goulburn Valley Health
Shepparton, Victoria 3630
AustraliaSite Not Available
Border Medical Oncology
Wodonga, Victoria 3690
AustraliaSite Not Available
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
Fiona Stanley Hospital (formerly Royal Perth Hospital)
Perth, Western Australia 6000
AustraliaSite Not Available
Prostate Cancer Institute - Southern Alberta Institute of Urology
Calgary, Alberta T2V 1P9
CanadaSite Not Available
Cross Cancer Institute
Edmonton, Alberta AB T6G 1Z2
CanadaSite Not Available
BCCA - Fraser Valley Cancer Center
Surrey, British Columbia BC V3V 1Z2
CanadaSite Not Available
BCCA Vancouver Centre
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
CancerCare Manitoba
Winnipeg, Manitoba
CanadaSite Not Available
Horizon Health Network - Dr Everett Chalmers Hospital
Fredericton, New Brunswick NB E3B 5N5
CanadaSite Not Available
Saint John Regional Hospital
Saint John, New Brunswick NB E2L 4L4
CanadaSite Not Available
QEII Health Sciences Centre, Capital District Health Authority
Halifax, Nova Scotia NS B3H 2Y9
CanadaSite Not Available
Cambridge Memorial Hospital
Cambridge, Ontario ON N1R 7S6
CanadaSite Not Available
Juravinski Cancer Centre
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario ON K7L 5P9
CanadaSite Not Available
London Regional Cancer Program
London, Ontario N6A 5W9
CanadaSite Not Available
Lakeridge Health Oshawa
Oshawa, Ontario ON L1G 2B9
CanadaSite Not Available
Ottawa Hospital Cancer Centre
Ottawa, Ontario ON K1H 8L6
CanadaSite Not Available
Algoma District Cancer Program Sault Area Hospital
Sault Ste. Marie, Ontario P6B 0A8
CanadaSite Not Available
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario ON P7B 6V4
CanadaSite Not Available
University Health Network - Princess Margaret Hospital
Toronto, Ontario ON M5G 2M9
CanadaSite Not Available
Hôpital Notre-Dame
Montreal, Quebec H2L 4M1
CanadaSite Not Available
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec City, Quebec QC G1R 2J6
CanadaSite Not Available
Allan Blair Cancer Centre
Regina, Saskatchewan S4T 7T1
CanadaSite Not Available
Saskatoon Cancer Centre
Saskatoon, Saskatchewan S7N 4H4
CanadaSite Not Available
Beaumont Hospital
Beaumont, Dublin Dublin 9
IrelandSite Not Available
Beacon Private Hospital
Dublin, Dublin 18
IrelandSite Not Available
Mater Misercordiae University Hospital
Dublin, Dublin 7
IrelandSite Not Available
Mater Private Hospital
Dublin, Dublin 7
IrelandSite Not Available
St James Hospital
Dublin, Dublin 8
IrelandSite Not Available
St Vincent's University Hospital
Dublin, Dublin 4
IrelandSite Not Available
St Vincent's University Hospital
Elm Park, Dublin 4
IrelandSite Not Available
Galway University Hospital
Galway,
IrelandSite Not Available
Adelaide and Meath Hospital - National Children's Hospital
Tallaght, Dublin 24
IrelandSite Not Available
University Hospital Waterford
Waterford,
IrelandSite Not Available
Auckland City Hospital
Auckland,
New ZealandSite Not Available
Christchurch Hospital
Christchurch, 8140
New ZealandSite Not Available
Waikato Hospital
Hamilton, 3204
New ZealandSite Not Available
Royal Cornwall Hospital
Truro, Cornwall TR1 3LQ
United KingdomSite Not Available
Royal Sussex Hospital
Brighton, East Sussex BN2 5BE
United KingdomSite Not Available
Kent and Canterbury Hospital
Canterbury, Kent CT1 3NG
United KingdomSite Not Available
Aberdeen Royal Infirmary
Aberdeen, Scotland AB25 2ZN
United KingdomSite Not Available
Velindre Cancer Centre
Cardiff, Wales CF14 2TL
United KingdomSite Not Available
Velindre Cancer Centre
South Glamorgan, Wales CF14 2TL
United KingdomSite Not Available
Guys and St Thomas Hospital
London, SE1 9RT
United KingdomSite Not Available
Royal Marsden Hospital
London, SW3 6JJ
United KingdomSite Not Available
University College Hospital London
London, NW1 2BU
United KingdomSite Not Available
University Hospital Southampton
Southampton, SO16 6YD
United KingdomSite Not Available
Great Western Hospital
Swindon, SN3 6BB
United KingdomSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United StatesSite Not Available
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