Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Official Title

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

Keywords

Castration-Resistant Prostatic Cancer, Prostatic Neoplasms, Castration-Resistant Prostatic Neoplasms, Prednisone, Abiraterone Acetate, Niraparib, New Formulation of Niraparib and Abiraterone Acetate (AA)

Eligibility

You can join if…

Open to males ages 18 years and up

  • HRR gene alteration (as identified by the sponsor's required assays) as follows:
    1. Cohort 1: positive for HRR gene alteration
    2. Cohort 2: not positive for DRD (that is, HRR gene alteration)
    3. Cohort 3: eligible by HRR status
  • Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
  • Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
  • Able to continue GnRHa during the study if not surgically castrate
  • Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

You CAN'T join if...

  • Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
  • Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
  • Symptomatic brain metastases
  • History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
  • Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Locations

  • UCSF
    San Francisco California 94158 United States
  • Sansum Clinic Pharm
    Santa Barbara California 93105 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03748641
Phase
Phase 3 Prostate Cancer Research Study
Study Type
Interventional
Participants
About 765 people participating
Last Updated