Access to Niraparib and Abiraterone Acetate Combination for Advanced Prostate Cancer

Sponsor: Janssen Research & Development, LLC

Expanded Access
Approved for Marketing
Sponsor score: 60

ClinicalTrials ID:NCT05401214

Provider View

This program provides access to a combination of Niraparib and Abiraterone Acetate for patients with advanced prostate cancer that has spread and is resistant to standard hormone therapy, specifically for those with certain genetic changes.

Patient Parameters

Program Overview

The goal of this program is to offer the combination of Niraparib and Abiraterone Acetate to patients with advanced prostate cancer that has spread and is resistant to standard hormone treatments. This is specifically for patients who have certain genetic changes known as Homologous Recombination Repair (HRR) gene alterations.

Eligibility Criteria

Inclusion Criteria

  • Have advanced prostate cancer that has spread and is resistant to standard hormone therapy.
  • Have a confirmed genetic change in the HRR gene, identified through a specific test.
  • Be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be willing to take a daily dose of prednisone or prednisolone while receiving the combination treatment.
  • Be willing to continue hormone therapy if not surgically castrated.

Exclusion Criteria

  • Have previously been treated with a PARP inhibitor.
  • Have received certain other treatments for advanced prostate cancer, except for ongoing hormone therapy or recent treatment with abiraterone acetate started within the last 60 days.
  • Have other treatment options available or be eligible for a clinical trial for advanced prostate cancer with HRR gene changes.
  • Have moderate to severe pain.
  • Have a history or current diagnosis of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.

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