Last updated on April 2019

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Malignant neoplasm of prostate
  • Age: Between 18 - 100 Years
  • Gender: Male

Inclusion Criteria:

  • Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded)
  • Received at least 1 line of taxane-based chemotherapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with documented evidence of disease progression prior to enrollment
  • Received at least 1 line of androgen receptor (AR)-targeted therapy (for example {e.g.}, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for treatment of mCRPC with documented evidence of disease progression prior to enrollment
  • Biomarker-positive for deoxyribonucleic acid (DNA)-repair anomalies
  • 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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