Official Title
Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
Brief Summary

The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.

Individual Patients
Metastatic Castration-Resistant Prostate Cancer

Drug: Niraparib plus Abiraterone Acetate (Nira/AA) combination
Nira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets.

Drug: Prednisone/Prednisolone
Prednisone/Prednisolone 10 mg will be administered orally.

Eligibility Criteria

Inclusion Criteria: - Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) - A confirmed homologous recombination repair (HRR) gene alteration as identified by a genomic assay through use of a validated test - Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1 - Willing to receive concomitant prednisone/ prednisolone 10 milligrams (mg) (not provided by Janssen) daily while receiving niraparib/abiraterone acetate (Nira/AA) combination treatment - Willing to continue treatment with gonadotropin-releasing hormone (GnRH) analogue if not surgically castrated

Exclusion Criteria: - Prior treatment with a Poly ADP-ribose Polymerase (PARP) inhibitor - Prior systemic therapy for mCRPC (that is, taxane-based chemotherapy, androgen signaling inhibitors). Ongoing androgen deprivation therapy (ADT), prior systemic treatment (example, apalutamide, enzalutamide, darolutamide, docetaxel) for earlier disease settings (example, hormone sensitive disease, non-metastatic castration-resistant disease); and treatment recently initiated with abiraterone acetate for mCRPC less than or equal to (

Eligibility Gender
Eligibility Age
Minimum: 18 Years

Study Contact
1-800-JANSSEN (1-800-526-7736)

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Janssen Research & Development, LLC
NCT Number
MeSH Terms
Prostatic Neoplasms
Abiraterone Acetate