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Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:
A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03821792
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 22, 2019
Completion date October 1, 2024
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