Trials / Active Not Recruiting
Active Not RecruitingNCT03821792
Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- 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 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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abiraterone Acetate | Given PO |
| DRUG | Apalutamide | Given PO |
| DRUG | Prednisone | Given PO |
Timeline
- Start date
- 2019-07-22
- Primary completion
- 2026-10-11
- Completion
- 2026-10-11
- First posted
- 2019-01-30
- Last updated
- 2026-04-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03821792. Inclusion in this directory is not an endorsement.