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A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

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Trial Profile

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

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

Latest Information Update: 27 Mar 2024

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At a glance

  • Drugs Enzalutamide (Primary) ; Leuprorelin (Primary) ; Leuprorelin (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBARK
  • Sponsors Medivation; Pfizer

    • Most Recent Events

    • 22 Mar 2024 According to an Astellas media release, based on results from this trial the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.
    • 30 Jan 2024 According to an Astellas media release, Health Canada granted a priority review of XTANDI in nmCSPC, which was further expedited as a result of XTANDI's inclusion in Project Orbis, an initiative of regulatory bodies, including Health Canada
    • 27 Jan 2024 Results outcomes in the enzalutamide + leuprolide acetate vs leuprolide-alone arms by treatment suspension status are presented at the 2024 Genitourinary Cancers Symposium.
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