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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)

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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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Abiraterone acetate (Primary) ; Abiraterone acetate/niraparib (Primary) ; Niraparib (Primary) ; Prednisone (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms AMPLITUDE
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 05 Dec 2024 Planned End Date changed from 27 May 2027 to 1 Nov 2027.
    • 05 Dec 2024 Planned primary completion date changed from 15 Nov 2024 to 7 Jan 2025.
    • 22 Sep 2023 Status changed from recruiting to active, no longer recruiting.

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