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Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 5, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Oct 22, 2024
    • Eligibility criteria expanded, about 19 words
    • Site details revised
    v3
  3. Start date: Oct 7, 2024 to Oct 2024v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AdventHealth
31 trials monitored
See 2 trials at risk
Prostate Cancer
2,546 trials monitored
See 172 trials at risk
The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.
Trial Details
NCT Number NCT06631521
Lead Sponsor AdventHealth
Collaborators: Bayer, Sumitomo Pharma Switzerland
Conditions
(from sponsor)		 Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
Related terms Adenocarcinoma, Prostatic Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov