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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2025

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At a glance

  • Drugs Darolutamide (Primary) ; Androgen receptor antagonists
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARASTEP
  • Sponsors Bayer

    • Most Recent Events

    • 06 Apr 2025 Planned number of patients changed from 750 to 970.
    • 13 Feb 2025 According to a Bayer media release, the data from this study will be presented at the upcoming American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place in San Francisco, California, from February 13-15, 2025.
    • 10 Feb 2025 Planned End Date changed from 28 Feb 2029 to 29 Mar 2030.

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