Houston Metro Urology | Research Department
Status and phase
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Study type
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Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
HRR gene alteration (as identified by the sponsor's required assays) as follows:
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)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
765 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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