clinical trial · NCT05826509
SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer
Institut Claudius Regaud·phase2·active not recruiting·n = 240
Prostate CancerSurgery alonePeri-operative darolutamide + surgery.
brief 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.
started
Aug 10, 2023
primary completion
Feb 1, 2031
completion
Feb 1, 2031
last updated
Mar 27, 2026
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol