Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Metastatic Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Prostate Carcinoma Metastatic in the Bone
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 a...

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.

Tracking Information

NCT #
NCT03821792
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul Corn M.D. Anderson Cancer Center
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024