NCT03360721

Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer

A Phase 2, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess the radiographic progression free survival (PFS) of men with metastatic castration resistant prostate cancer (mCRPC) who are selected for treatment based on positive biomarker signature. SECONDARY OBJECTIVES: I. Safety. II. Composite progression free survival (PFSc) defined by Prostate Cancer Working Group 2 (PCWG2) (radiographic progression, prostate specific antigen \[PSA\] progression, or clinical deterioration). III. Overall survival. IV. Exploratory biomarker analyses. V. Measures of prostate specific antigen (PSA) decline and associations with outcome. VI. Radiologic response by PCWG2 criteria. VII. Measures of circulating tumor cell (CTC) and conversion to undetectable and/or favorable \< 5. OUTLINE: Participants receive abiraterone acetate orally (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. After completion of study treatment, participants are followed up for up to 16 months.

Conditions

• Castration-Resistant Prostate Carcinoma
• Prostate Adenocarcinoma Without Neuroendocrine Differentiation
• Stage IV Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Given PO
DRUG	Apalutamide	Given PO
DRUG	Prednisone	Given PO

Timeline

• Start date: 2018-03-06
• Primary completion: 2026-03-12
• Completion: 2026-03-12
• First posted: 2017-12-04
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study