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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02446405




Registration number
NCT02446405
Ethics application status
Date submitted
4/05/2015
Date registered
18/05/2015
Date last updated
3/05/2018

Titles & IDs
Public title
Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer
Scientific title
Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
Secondary ID [1] 0 0
ACTRN12614000110684
Secondary ID [2] 0 0
ANZUP 1304
Universal Trial Number (UTN)
Trial acronym
ENZAMET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enzalutamide
Treatment: Drugs - NSAA
Treatment: Drugs - LHRHA or Surgical Castration

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.

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.


Treatment: Drugs: Enzalutamide


Treatment: Drugs: NSAA


Treatment: Drugs: LHRHA or Surgical Castration


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Time
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Prostate specific antigen progression free survival time
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Clinical progression free survival time
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
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))
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Healthcare resource cost-effectiveness (incremental cost effectiveness ratio)
Timepoint [5] 0 0
3 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
Concord Cancer Centre - Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [5] 0 0
Nepean Cancer Care Centre - Kingswood
Recruitment hospital [6] 0 0
St. George Hospital - Kogarah
Recruitment hospital [7] 0 0
Central West Cancer Services - Orange
Recruitment hospital [8] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [9] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [10] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [11] 0 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [12] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [13] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [14] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [15] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [16] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [17] 0 0
Townsville Hospital - Douglas
Recruitment hospital [18] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [19] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [20] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [21] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [22] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [23] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [24] 0 0
Adelaide Cancer Centre - Ashford Cancer Care Centre - Kurralta Park
Recruitment hospital [25] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [26] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [27] 0 0
Monash Cancer Centre Moorabbin - Bentleigh East
Recruitment hospital [28] 0 0
Peter MacCallum Cancer Centre - East Melbourne - East Melbourne
Recruitment hospital [29] 0 0
St. Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [30] 0 0
Peninsula South Eastern Haematology & Oncology Group- Peninsula Oncology Centre - Frankston
Recruitment hospital [31] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [32] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [33] 0 0
Australian Urology Associates - Malvern
Recruitment hospital [34] 0 0
Eastern Health Box Hill Hospital - Melbourne
Recruitment hospital [35] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [36] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [37] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [38] 0 0
Fiona Stanley Hospital (formerly Royal Perth Hospital) - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
2747 - Kingswood
Recruitment postcode(s) [6] 0 0
2217 - Kogarah
Recruitment postcode(s) [7] 0 0
2800 - Orange
Recruitment postcode(s) [8] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [9] 0 0
2031 - Randwick
Recruitment postcode(s) [10] 0 0
2065 - St Leonards
Recruitment postcode(s) [11] 0 0
2340 - Tamworth
Recruitment postcode(s) [12] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [13] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [14] 0 0
2076 - Wahroonga
Recruitment postcode(s) [15] 0 0
2500 - Wollongong
Recruitment postcode(s) [16] 0 0
0810 - Tiwi
Recruitment postcode(s) [17] 0 0
4814 - Douglas
Recruitment postcode(s) [18] 0 0
4006 - Herston
Recruitment postcode(s) [19] 0 0
4560 - Nambour
Recruitment postcode(s) [20] 0 0
4215 - Southport
Recruitment postcode(s) [21] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [22] 0 0
5000 - Adelaide
Recruitment postcode(s) [23] 0 0
5042 - Bedford Park
Recruitment postcode(s) [24] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [25] 0 0
7000 - Hobart
Recruitment postcode(s) [26] 0 0
- Bendigo
Recruitment postcode(s) [27] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [28] 0 0
3002 - East Melbourne
Recruitment postcode(s) [29] 0 0
3065 - Fitzroy
Recruitment postcode(s) [30] 0 0
3199 - Frankston
Recruitment postcode(s) [31] 0 0
3220 - Geelong
Recruitment postcode(s) [32] 0 0
3084 - Heidelberg
Recruitment postcode(s) [33] 0 0
3144 - Malvern
Recruitment postcode(s) [34] 0 0
- Melbourne
Recruitment postcode(s) [35] 0 0
3630 - Shepparton
Recruitment postcode(s) [36] 0 0
3690 - Wodonga
Recruitment postcode(s) [37] 0 0
6009 - Nedlands
Recruitment postcode(s) [38] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Manitoba
Country [5] 0 0
Canada
State/province [5] 0 0
New Brunswick
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Canada
State/province [9] 0 0
Saskatchewan
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
Ireland
State/province [11] 0 0
Galway
Country [12] 0 0
Ireland
State/province [12] 0 0
Tallaght
Country [13] 0 0
Ireland
State/province [13] 0 0
Waterford
Country [14] 0 0
New Zealand
State/province [14] 0 0
Auckland
Country [15] 0 0
New Zealand
State/province [15] 0 0
Christchurch
Country [16] 0 0
New Zealand
State/province [16] 0 0
Hamilton
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Cornwall
Country [18] 0 0
United Kingdom
State/province [18] 0 0
East Sussex
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Kent
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Scotland
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Wales
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Southampton
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Swindon

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cancer Trials Ireland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
NCIC Clinical Trials Group
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02446405
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Sweeney
Address 0 0
Dana Farber Cancer Institute and ANZUP
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications