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Antiandrogen

Enzalutamide + ADT for Metastatic Prostate Cancer (ENZAMET Trial)

Phase 3
Waitlist Available
Research Sponsored by University of Sydney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male aged 18 or older with metastatic adenocarcinoma of the prostate
Adequate liver function: Alanine transaminase (ALT) < 2 x Upper Limit of Normal (ULN), bilirubin < 1.5 x ULN (or if bilirubin is between 1.5-2 x ULN, normal conjugated bilirubin required). ALT < 5 x ULN if liver metastases are present
Must not have
Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
Concurrent illness, including severe infection that might jeopardize ability to undergo procedures with reasonable safety
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial is testing whether a new drug, enzalutamide, is more effective than 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.

Who is the study for?
Men 18+ with newly diagnosed metastatic prostate cancer can join this trial. They must have certain levels of blood cells, liver and kidney function, and be able to start treatment within a week after joining. Those with specific heart conditions, other cancers in the past 5 years, or severe infections cannot participate.Check my eligibility
What is being tested?
The study is testing if enzalutamide is more effective than traditional anti-androgens when combined with hormone therapy or surgery for first line treatment of advanced prostate cancer. Participants will receive either enzalutamide or a non-steroidal anti-androgen as part of their therapy.See study design
What are the potential side effects?
Enzalutamide may cause seizures, high blood pressure, fatigue, back pain and constipation among other side effects. Hormone therapy might lead to hot flashes, reduced sexual desire and bone thinning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man over 18 with advanced prostate cancer.
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My liver functions within the normal range, even if I have liver metastases.
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My kidneys work well enough (creatinine clearance over 30 ml/min).
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My blood tests show normal levels of hemoglobin, white cells, and platelets.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer has specific aggressive features.
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I do not have any severe illnesses that could make treatment unsafe for me.
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I haven't had serious heart problems in the last 3 months.
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I am sexually active and do not use or cannot use birth control methods.
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I haven't had seizures, fainting, or mini-strokes in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival Time
Secondary outcome measures
Adverse events
Clinical progression free survival time
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))
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EnzalutamideExperimental Treatment2 Interventions
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.
Group II: Conventional NSAAActive Control2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved

Find a Location

Who is running the clinical trial?

NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
143,716 Total Patients Enrolled
20 Trials studying Prostate Cancer
44,244 Patients Enrolled for Prostate Cancer
National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
473,752 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,071 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupNETWORK
127 Previous Clinical Trials
67,179 Total Patients Enrolled
11 Trials studying Prostate Cancer
7,135 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02446405 — Phase 3
Prostate Cancer Research Study Groups: Enzalutamide, Conventional NSAA
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02446405 — Phase 3
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02446405 — Phase 3
~99 spots leftby Jul 2025
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