Clinical Research Details

Clinical Research

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

Study Description

Study Description:  The purpose of this study is to evaluate the effectiveness of study drug, niraparib in combination with abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo. This study will assess efficacy and safety of niraparib in combination with AA-P for the treatment of participants with metastatic prostate cancer.

Eligibility:

Inclusion Criteria:

Adult Males (Age ≥ 18 years) Positive for DNA-repair gene defects (DRD) status Please reach out to study coordinator for testing Prior treatment with a poly adenosine diphosphate ribose polymerase (PARP) inhibitor Systemic therapy such as enzalutamide, apalutamide, or darolutamide; certain types of chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AA-P] after surgical or medical castration; or AA-P treatment for some other disease Symptomatic brain metastases History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) Other prior cancers (exceptions: treated basal cell or squamous cell skin cancer, some bladder cancers, or any other cancer in complete remission) 2 years before start of the study, or malignancy that currently requires active therapy Uncontrolled pain or other medical conditions Metastatic disease documented by bone scan, computed tomography (CT) or magnetic resonance imaging (MRI) Metastatic prostate cancer with testosterone levels less than or equal to  50 ng/dL Able to continue hormone therapy during the study if not surgically castrated

 

Exclusion Criteria:

Prior treatment with a poly adenosine diphosphate ribose polymerase (PARP) inhibitor Systemic therapy such as enzalutamide, apalutamide, or darolutamide; certain types of chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AA-P] after surgical or medical castration; or AA-P treatment for some other disease Symptomatic brain metastases History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) Other prior cancers (exceptions: treated basal cell or squamous cell skin cancer, some bladder cancers, or any other cancer in complete remission) 2 years before start of the study, or malignancy that currently requires active therapy Uncontrolled pain or other medical conditions

Open Enrollment

Contact Name: Brandi Calderon
Contact Phone: (904) 244-7413
Contact Email: brandi.calderon@jax.ufl.edu

Investigators


Principal Investigator
K.C. Balaji, M.B.B.S. (M.D.), FRCS, MRCS, LRCP
Urology

Sub Investigator
Mark Bandyk, M.D., M.P.H., M.S.
Urology