Phase 2
Completed N=289
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Source: ClinicalTrials.gov NCT02854436 ↗Enrolled (actual)
289
Serious AEs
46.4%
Results posted
Mar 2022
Primary outcomePrimary: Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation — 34.2 percentage of participants
Summary
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation |
34.2 | — |
| SECONDARY Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation |
10.6 | — |
| SECONDARY Circulating Tumor Cells (CTC) Response Rate |
23.7; 8.5 | — |
| SECONDARY Overall Survival (OS) |
13.01; 9.63 | — |
| SECONDARY Radiographic Progression-Free Survival (rPFS) |
8.08; 3.71 | — |
| SECONDARY Time to Radiographic Progression |
8.08; 3.78 | — |
| SECONDARY Time to Prostate-Specific Antigen (PSA) Progression |
5.13; 3.65 | — |
| SECONDARY Time to Symptomatic Skeletal Event (SSE) |
13.80; 10.35 | — |
| SECONDARY Duration of Objective Response |
5.55; 5.16 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
288 | — |
| SECONDARY Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) |
67; 4; 102; 7; 70; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is excluded)
- Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event
- Received a second-generation or later androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis
- Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing)
- Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry
Exclusion Criteria
- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
- Prior platinum-based chemotherapy for the treatment of prostate cancer
- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
- Symptomatic or impending cord compression
- Symptomatic brain metastases
Data sourced from ClinicalTrials.gov (NCT02854436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.