A Phase III Study of Abiraterone Acetate and Prednisone with and without Niraparib to Treat Metastatic Prostate Cancer with Certain Genetic Changes

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Full Title

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Purpose

One of the usual treatments for metastatic prostate cancer is abiraterone acetate combined with prednisone. In this study, researchers want to find out whether adding a drug called niraparib to the usual approach may be better than the usual approach for shrinking the cancer and preventing it from coming back or spreading in men with metastatic prostate cancer who have a mutation in an HRR gene, which can cause cancer cells to grow quickly and out of control.

Niraparib belongs to a class of drugs called PARP inhibitors. PARP is a protein that helps repair damage to DNA, the genetic material that serves as the body’s instruction book. Niraparib prevents PARP from working, so cancer cells cannot repair themselves and they stop growing.

Patients in this study will be randomly assigned to receive abiraterone acetate and prednisone with niraparib or a placebo. All of the medications in this study are 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 hormone therapy-sensitive prostate cancer and an HRR mutation.
  • Patients may not have previously received a PARP inhibitor.

For more information about this study and to inquire about eligibility, please contact Dr. Dana Rathkopf at 646-422-4379.

Protocol

21-231

Phase

III

Investigator

Co-Investigators