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

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.

Timeline

Start

2023-08-10

Primary completion

2031-02

Completion

2031-02

Publications

• Background Calleris G, Filleron T, Kesch C, Roubaud G, Pradere B, Cabarrou B, Malavaud B, Roupret M, Mourey L, Ploussard G. Surgery with or Without Darolutamide in High-risk and/or Locally Advanced Prostate Cancer: The SUGAR (CCAFU-PR2) Phase 2 Trial Rationale and Protocol. Eur Urol Oncol. 2024 Jun;7(3):494-500. doi: 10.1016/j.euo.2023.09.020. Epub 2023 Oct 6.

Drugs

Indications