Clinical Trial

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

Study acronym: SUGAR

Active, Not Recruiting Phase 2

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.

Protocol Amendment History 22 amendments

This ClinicalTrials.gov record has been amended 22 times since 2023-04-12; most recent amendment 2026-05-05.

Status change: Recruiting → Active, Not Recruiting 2026-01-13

Status change: Not Yet Recruiting → Recruiting 2023-07-10

Trial Details

NCT Number	NCT05826509
Lead Sponsor	Institut Claudius Regaud Collaborators: Bayer
Conditions	Prostate Cancer
Enrollment	240 participants
Start Date	2023-08-10
Primary Completion	2031-02 (estimated)
Study Completion	2031-02 (estimated)
Updated on ClinicalTrials.gov	2026-05-08