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China ARCHES: A Multicenter, Phase 3, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Trial Profile

China ARCHES: A Multicenter, Phase 3, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

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

Latest Information Update: 19 Oct 2024

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At a glance

  • Drugs Enzalutamide (Primary) ; LHRH receptor agonists; LHRH receptor antagonists
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms China ARCHES
  • Sponsors Astellas Pharma China
  • Most Recent Events

    • 21 Dec 2023 Planned End Date changed from 31 Oct 2025 to 31 Dec 2028.
    • 24 Oct 2023 Results of prespecified interim analysis (n=180; At data cut-off November 18, 2022) assessing the efficacy and safety of enzalutamide plus plus androgen deprivation therapy versus placebo plus ADT in Chinese patients with metastatic hormone-sensitive prostate cancer, presented at the 48th European Society for Medical Oncology Congress.
    • 19 Sep 2023 According to an Astellas Pharma media release, Results from China ARCHES will be presented in a poster presentation during the European Society of Medical Oncology (ESMO) Congress 2023.

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