Apalutamide + Abiraterone + Prednisone for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBagi Jana, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.

Eligibility Criteria

Men with metastatic castration resistant prostate cancer, who have low testosterone levels and progressive disease despite ongoing hormone therapy. They must be able to give consent, swallow pills, and agree to use two forms of birth control if sexually active with a woman of childbearing potential. Excluded are those with severe health issues like uncontrolled hypertension or heart problems, recent major surgery, brain metastases, certain blood disorders or allergies to study drugs.

Inclusion Criteria

Estimated life expectancy of >= 6 months

Willing and able to give informed consent

Serum testosterone level =< 50 ng/dL at the screening visit

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Exclusion Criteria

Severe, concurrent disease, infection, or co-morbidity that would make the patient inappropriate for enrollment or other medical condition that would make corticosteroid use contraindicated

I have had cancer other than skin cancer in the past 2 years with a high chance of return.

Abnormal blood counts or levels (ANC, platelet count, hemoglobin, total bilirubin, ALT, AST, creatinine)

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Participant Groups

The trial is testing the effectiveness of combining apalutamide and abiraterone acetate—drugs that block tumor growth enzymes—with prednisone which suppresses the immune system and may improve bone marrow function in treating metastatic prostate cancer that resists castration treatment.

1Treatment groups

Experimental Treatment

Group I: Treatment (abiraterone acetate, apalutamide, prednisone)Experimental Treatment3 Interventions

Participants receive abiraterone acetate PO once daily QD, apalutamide PO QD, and prednisone PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Zytiga for: