Principal Investigator:Smith, Matthew, R.
Site Investigator(s):Bubley, Glenn,
Pomerantz, Mark, M.
Site Research Nurse(s):Gundy, Kathryn, E.
Markt, Denise, A.
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.
- 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
- 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
- Progression of metastatic prostate cancer in the setting of castrate levels of
testosterone or history of bilateral orchiectomy at study entry
- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)
- Prior platinum-based chemotherapy for the treatment of prostate cancer
- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid
- Symptomatic or impending cord compression
- Symptomatic brain metastases
Protocol #: 16-493