The purpose of the study is to determine if the combination of niraparib with Abiraterone
Acetate (AA) plus prednisone compared with AA plus prednisone in participants with
deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated
Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in
improving radiographic progression-free survival (rPFS).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04497844.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted
specific germline and somatic mutations and alternative driver growth signaling pathways
in patients with metastatic disease. Abiraterone acetate plus prednisone (AAP) is an
established standard of care for the treatment of participants with mCSPC and is included
in widely accepted clinical treatment guidelines. Niraparib in combination with AAP has
been approved for the treatment of BRCA-mutated Metastatic Castration-Resistant Prostate
Cancer (mCRPC). Niraparib is an investigational agent in the Metastatic
Castration-Sensitive Prostate Cancer (mCSPC) population. Whether the addition of
niraparib to the AAP standard of care may improve initial disease control and long-term
outcomes compared with AAP alone in a biomarker selected mCSPC population is being
evaluated on this trial. The study will consist of 4 phases; a Prescreening Phase for
biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a
Follow-up Phase. Efficacy evaluations include the following: tumor measurements by
computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis),
Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations,
and patient reported outcomes (PROs). Safety evaluations include incidence of adverse
events and clinical laboratory parameters.
Lead OrganizationJanssen Research & Development, LLC