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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

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival Time

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 9Eligibility criteria met