Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
NCT03821792 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-15
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.
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
- DRUG
-
Abiraterone Acetate
Given PO
- DRUG
-
Apalutamide
Given PO
- DRUG
-
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Paul Corn · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-22
- Primary Completion
- 2026-10-11
- Completion
- 2026-10-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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