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Approved for marketingNCT05401214Updated Jun 13, 2025

Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

An expanded access record providing Niraparib plus Abiraterone Acetate (Nira/AA) combination and Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer, sponsored by Janssen Research & Development, LLC. Approved for marketing. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Janssen Research & Development, LLC · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Metastatic Castration-resistant Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

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Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male

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

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 (\<=) 60 days is permitted
  • Other treatment options available or participant eligible or able to participate in a clinical trial for first line mCRPC with HRR gene alterations
  • Moderate-severe pain
  • History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
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Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • DrugNiraparib plus Abiraterone Acetate (Nira/AA) combination

    Nira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets.

  • DrugPrednisone/Prednisolone

    Prednisone/Prednisolone 10 mg will be administered orally.

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Where to request access

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05401214
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Jun 2, 2022
Last update
Jun 13, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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