Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT03360721 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2026-03-16
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.
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
- 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
-
Bagi Jana, MD · 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
- 2018-03-06
- Primary Completion
- 2026-03-12
- Completion
- 2026-03-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
NCT01309672 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT02257736 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
NCT03098836 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
NCT01576172 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
NCT02913196 ·Status: COMPLETED ·Phase: PHASE1
-
Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT01503229 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels
NCT02867020 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
NCT02807805 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide
NCT01946165 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate for Castrate Resistant Prostate Cancer
NCT01961843 ·Status: COMPLETED ·Phase: NA
-
Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study
NCT04585932 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer
NCT01591122 ·Status: COMPLETED ·Phase: PHASE3
-
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
NCT02903368 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
NCT06173362 ·Status: RECRUITING ·Phase: PHASE2
-
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
NCT00002855 ·Status: COMPLETED ·Phase: PHASE3
-
Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
NCT03436654 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Sequencing Abiraterone and Enzalutamide in mCRPC
NCT02125357 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer
NCT03093272 ·Status: TERMINATED ·Phase: PHASE2
-
Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
NCT03072238 ·Status: COMPLETED ·Phase: PHASE3
-
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
NCT00638690 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
NCT05968599 ·Status: COMPLETED
-
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
NCT03748641 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
NCT07086651 ·Status: COMPLETED
-
Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
NCT03412396 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT01685125 ·Status: UNKNOWN ·Phase: PHASE2