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Clinical trial

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)

NCT04497844 is registered in ClinicalTrials.gov with Janssen Research & Development, LLC as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Overall status
Active, not recruiting
Start date
September 23, 2020
Completion date
November 1, 2027
Enrollment
696 (actual)
Sites
387

Conditions

As the registry lists them; a condition with its own page is linked.