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A Single-arm, Open-label Phase 4 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy for Participants in India With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

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Trial Profile

A Single-arm, Open-label Phase 4 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy for Participants in India With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Darolutamide (Primary) ; Androgen receptor antagonists
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Bayer

Most Recent Events

  • 11 Jan 2024 Planned End Date changed from 27 Sep 2024 to 28 Jan 2026.
  • 11 Jan 2024 Planned primary completion date changed from 27 Sep 2024 to 28 Jan 2026.
  • 13 Jun 2023 Planned End Date changed from 2 Jan 2024 to 27 Sep 2024.

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