NCT05826509

SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/or locally advanced prostate cancer. In this trial, patients will be assigned in one of the two following treatments arms: * Arm A (control arm): Surgery alone (radical prostatectomy with lymph node dissection) * Arm B (experimental arm): Peri-operative darolutamide + surgery (radical prostatectomy with lymph node dissection) A total of 240 patients will have to be randomized with 120 patients in the control arm and 120 patients in the experimental arm.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Surgery alone	Radical prostatectomy with lymph node dissection will be performed.
DRUG	Peri-operative darolutamide + surgery.	Darolutamide: 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg; for a total duration of 9 months. Darolutamide will start at day 1. Surgery: radical prostatectomy with lymph node dissection will be performed after at least 3 months of darolutamide treatment.

Timeline

• Start date: 2023-08-10
• Primary completion: 2031-02-01
• Completion: 2031-02-01
• First posted: 2023-04-24
• Last updated: 2026-03-27

Locations

19 sites across 1 country: France