Spots Global Cancer Trial Database for Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer

Study Description

Brief Summary: This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.

Detailed Description: PRIMARY OBJECTIVES: I. Determine if a baseline molecular-pathologic androgen receptor response (AR-response) signature predicts efficacy to abiraterone plus apalutamide in patients with hormone-naive metastatic prostate cancer (HNMPCa). SECONDARY OBJECTIVES: I. Evaluate the efficacy of abiraterone acetate plus apalutamide in patients with HNMPCa. II. Evaluate the safety of abiraterone acetate plus apalutamide in patients with HNMPCa. III. Explore the relationship between molecular markers and clinical efficacy outcomes. OUTLINE: Patient receive abiraterone acetate orally (PO) daily, prednisone PO twice daily (BID), and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then for up to 6 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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