SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer
Status:
Not yet recruiting
Trial end date:
2030-05-01
Target enrollment:
Participant gender:
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.