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ACTIVE_NOT_RECRUITINGPHASE3

Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

NCT02446405•University of Sydney

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Men starting first line androgen deprivation therapy for metastatic prostate cancer.
•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)
•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;
+6 more criteria

Locations (82)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia

Concord Cancer Centre - Concord Repatriation General Hospital

Concord, New South Wales, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Nepean Cancer Care Centre

Kingswood, New South Wales, Australia

St. George Hospital

Kogarah, New South Wales, Australia

Central West Cancer Services

Orange, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Key Dates

Start Date

March 1, 2014

Primary Completion Date

December 31, 2026

Completion Date

June 30, 2027

Last Updated

February 6, 2025

Enrollment

1,125

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

Enzalutamide

DRUG

NSAA

DRUG

LHRHA or Surgical Castration

DRUG

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07225946

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITING

Prostate Active Surveillance Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Prostate Active Surveillance Study

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Clinical Application of the J-PET Scanner Prototype