A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
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).
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.
Inclusion criteria:
Exclusion criteria:
Orange, California 92868, United States
Fort Lauderdale, Florida 33308, United States
C.a.b.a., C1426BOR, Argentina
Caba, C1056ABI, Argentina
Ciudad Automoma Buenos Aires, C1120AAT, Argentina
Ciudad Autonoma de, C1199ABB, Argentina
Ciudad de Buenos Aires, C1430EGF, Argentina
Córdoba, 5000, Argentina
Haine-St-Paul, 7100, Belgium
Goiânia, 74605-070, Brazil
Joinville, 89201-260, Brazil
Rio de Janeiro, 22775 001, Brazil
São Paulo, 01246 000, Brazil
Kelowna, British Columbia V1Y 5L3, Canada
Kingston, Ontario K7L2V7, Canada
Wuhan, 430030, China
Petach Tikvah, 49100, Israel
Dunedin Central, 9016, New Zealand
Coimbra, 3000075, Portugal
Hato Rey, 00917, Puerto Rico
Ankara, 06200, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Cherkasy, 18009, Ukraine
Dnipro, 49005, Ukraine
Dnipro, 49100, Ukraine
Dnipro, 49102, Ukraine
Kamyanske, 51900, Ukraine
Khakhiv, 61070, Ukraine
Kharkiv, 61037, Ukraine
Kyiv, 03115, Ukraine
Lviv, 79010, Ukraine
Zhytomyr, 10002, Ukraine
Great Maze Pond, SE1 9RT, United Kingdom