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A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India

Study acronym: PACE mHSPC
StatusNot Yet Recruiting
PhaseNot specified
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 50 → 60 participants Start date pushed from Oct 5, 2026 to Oct 15, 2026 · Study sites: 1 to 0 · Primary and study completion dates: Oct 31, 2028 to Nov 15, 2028 Show 3 more changesShow less
    • Start date pushed from Oct 5, 2026 to Oct 15, 2026
    • Study sites: 1 to 0
    • Primary and study completion dates: Oct 31, 2028 to Nov 15, 2028
  2. Study sites: 0 to 1
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bayer
131 trials monitored
See 7 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care. The study aims to describe the real-world safety profile of darolutamide plus androgen deprivation therapy over up to 1 year of follow-up, including adverse events, serious adverse events, adverse events categorized as special topics, treatment changes, and changes in laboratory values, vital signs, and Eastern Cooperative Oncology Group performance status.
Trial Details
NCT Number NCT07806591
Lead Sponsor Bayer
Conditions Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov