Enzalutamide +/- Abiraterone + Prednisone for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+538 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Eligibility Criteria

Men aged 18+ with castration-resistant metastatic prostate cancer, who have not used certain treatments recently and do not have severe heart conditions, brain metastases, or other specific health issues. Participants must show disease progression despite ongoing androgen deprivation therapy.

Inclusion Criteria

My prostate cancer symptoms are mild or non-existent.

My prostate cancer is worsening despite hormone therapy and has not turned into a more aggressive type.

My cancer can be measured or observed.

+5 more

Exclusion Criteria

Patient is living outside the US

I have a history of cancer.

I haven't had cancer in the last 5 years, except for skin cancer.

+14 more

Participant Groups

The trial is testing if enzalutamide alone is as effective as a combination of enzalutamide, abiraterone, and prednisone in treating advanced prostate cancer that no longer responds to hormonal therapy aimed at lowering androgens.

2Treatment groups

Experimental Treatment

Group I: Arm B: (enzalutamide, abiraterone, prednisone)Experimental Treatment3 Interventions

Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.

Group II: Arm A: (enzalutamide)Experimental Treatment1 Intervention

Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Xtandi for: