Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
Overview
- Phase
- Phase 3
- Intervention
- Enzalutamide
- Conditions
- Prostatic Neoplasms
- Sponsor
- University of Sydney
- Enrollment
- 1125
- Locations
- 82
- Primary Endpoint
- Overall Survival Time
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
- •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.
- •Life expectancy of less than 12 months.
- •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).
- •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.
- •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;
- •Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
Arms & Interventions
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.
Intervention: Enzalutamide
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.
Intervention: LHRHA or Surgical Castration
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.
Intervention: NSAA
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.
Intervention: LHRHA or Surgical Castration
Outcomes
Primary Outcomes
Overall Survival Time
Time Frame: 3 years
the interval from the date of randomisation to date of death.
Secondary Outcomes
- Adverse events(3 years)
- Healthcare resource cost-effectiveness (incremental cost effectiveness ratio)(3 years)
- Clinical progression free survival time(3 years)
- 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))(3 years)
- Prostate specific antigen progression free survival time(3 years)