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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: 11 Oct 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

    • 22 Sep 2023 Status changed from recruiting to active, no longer recruiting.
    • 28 Jun 2023 Planned End Date changed from 7 May 2027 to 27 May 2027.
    • 13 Feb 2021 Trial design presented at the 2021 Genitourinary Cancers Symposium

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