NCT03098836

Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer

Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Daniel George, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA \< 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period. Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ARN-509	240 mg orally daily
DRUG	Abiraterone Acetate	1000 mg orally daily
DRUG	Prednisone	5 mg orally twice daily (for total daily dose 10 mg)

Timeline

• Start date: 2017-07-10
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2017-04-04
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study