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
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
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.
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:
New York, New York 10029, United States
Ciudad Automoma Buenos Aires, C1120AAT, Argentina
Córdoba, 5000, Argentina
Macquarie University, 2109, Australia
Liège, B-4000, Belgium
Brasília, 7020-730, Brazil
Goiânia, 74605-070, Brazil
Joinville, 89201-260, Brazil
Rio de Janeiro, 22775 001, Brazil
São Paulo, 01246 000, Brazil
Kingston, Ontario K7L 3N6, Canada
Wuhan, 430030, China
Hradec Králove, 500 05, Czechia
Budapest, 1122, Hungary
Nyíregyháza, 4400, Hungary
Beer Yaakov, 60930, Israel
Perugia, 06132, Italy
Sittard-Geleen, 6162 BG, Netherlands
Warsaw, 02-781, Poland
Cherkasy, 18009, Ukraine
Dnipo, 49005, Ukraine
Dnipro, 49100, Ukraine
Dnipro, 49102, Ukraine
Khakhiv, 61070, Ukraine
Kyiv, 03115, Ukraine
Poltava, 36024, Ukraine