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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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

Latest Information Update: 07 May 2025

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At a glance

  • Drugs Darolutamide (Primary) ; Luteinising hormone modulators
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARANOTE
  • Sponsors Bayer

Most Recent Events

  • 27 Apr 2025 Planned End Date changed from 26 Sep 2025 to 30 Jan 2026.
  • 16 Apr 2025 According to a Bayer media release, data from this study will be presented at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025.
  • 13 Feb 2025 According to a Bayer media release, full results of ARANOTE trial were presented during the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025 Congress.

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