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

Institut Claudius Regaud · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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locally-advancedprostate-cancer
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.
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