A Phase II Study of Niraparib for Men with Metastatic Castration-Resistant Prostate Cancer and DNA Repair Problems

Full Title

64091742PCR2001: A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Purpose

The benefits of hormone treatments for men with prostate cancer that has metastasized (spread to other organs) do not last. Over time, many prostate cancers continue to grow despite hormonal therapies (and are called “castration-resistant” prostate cancer, or CRPC). In this study, researchers are evaluating the safety and effectiveness of the drug niraparib in men with metastatic CRPC and defective DNA repair.

Niraparib works by inhibiting PARP, a protein that helps cancer cells repair DNA that has been damaged by cancer treatments. When cancer cells repair damaged DNA, they can continue growing and multiplying, so depriving them of this power with a PARP inhibitor may be an effective approach to treatment.

Niraparib is used to treat advanced ovarian cancer; its use in this study is considered investigational. It is a capsule that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic CRPC that has continued to grow despite two regimens of therapy which included a taxane drug (such as docetaxel) and an androgen receptor inhibitor (such as abiraterone acetate, enzalutamide, or apalutamide).
  • Patients must show evidence of faulty DNA repair.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Daniel Danila at 646-422-4612.

Protocol

18-068

Phase

II

Investigator

Co-Investigators