Clinical Trial: NCT05689021
CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations
Status:
TERMINATEDPhase:
Phase 2| Lead Sponsor: | Mayo Clinic |
| Information Provided By: | Mayo Clinic |
| Last Update Posted: | 2026-07-22 |
Study Overview
Brief Summary
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone.
Official Title
Conditions
Intervention / Treatment
- Drug: Abiraterone Acetate/Niraparib
- Procedure: Biospecimen Collection
- Procedure: Bone Scan
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Drug: Prednisone
Other Study ID Numbers
- MC210503
- 21-010477
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Mayo Clinic |
| Information Provided By: | Mayo Clinic |
| Last Update Posted: | 2026-07-22 |
Study Overview
Brief Summary
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone.
Official Title
Conditions
Intervention / Treatment
- Drug: Abiraterone Acetate/Niraparib
- Procedure: Biospecimen Collection
- Procedure: Bone Scan
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Drug: Prednisone
Other Study ID Numbers
- MC210503
- 21-010477