Metastatic Castration-resistant Prostate CancerNCT05401214
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
A study testing Niraparib plus Abiraterone Acetate (Nira/AA) combination and Prednisone/Prednisolone in people with Metastatic Castration-resistant Prostate Cancer, run by Janssen Research & Development, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Niraparib plus Abiraterone Acetate (Nira/AA) combination and Prednisone/Prednisolone
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
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.
- Being tested
- Niraparib plus Abiraterone Acetate (Nira/AA) combination, Prednisone/Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib plus Abiraterone Acetate (Nira/AA) combinationDrug
Nira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets.
Prednisone/PrednisoloneDrug
Prednisone/Prednisolone 10 mg will be administered orally.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401214
- Sponsor's protocol ID
- CR109197
- Other IDs
- 67652000MPC4002
- Status last verified
- Jun 2025
- First submitted
- 27 May 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
- ClinicalTrials.gov ID
- NCT05401214
- Acronym / sponsor ID
- CR109197
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib plus Abiraterone Acetate (Nira/AA) combinationNira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets. | Drug | – |
| Prednisone/PrednisolonePrednisone/Prednisolone 10 mg will be administered orally. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Niraparib plus Abiraterone Acetate (Nira/AA) combination and Prednisone/Prednisolone in people with Metastatic Castration-resistant Prostate Cancer, run by Janssen Research & Development, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.