Enzalutamide + ADT for Metastatic Prostate Cancer
(ENZAMET Trial)

Recruiting in Palo Alto (17 mi)

+83 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Sydney

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

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.

Inclusion Criteria

I am a man over 18 with advanced prostate cancer.

Presence of target or non-target lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1

My liver functions within the normal range, even if I have liver metastases.

+7 more

Exclusion Criteria

Life expectancy of less than 12 months

My prostate cancer has specific aggressive features.

I have had hormone therapy for prostate cancer, but only in certain situations.

+9 more

Participant Groups

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.

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.

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Xtandi for: