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

Study acronym: SUGAR
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study Status, Referencesv23
  2. Study sites: 20 to 19v22
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 20 of 20 sites
    v21
  4. Site details revised at 2 of 20 sitesv20
  5. Study sites: 18 to 20v19
Show 17 earlier versionsHide 17 earlier versions
  1. Primary and study completion dates: May 2030 to Feb 2031
    • Study sites: 17 to 18
    v18
  2. Site contacts updated at 1 of 17 sitesv17
  3. Site details revised at 1 of 17 sitesv16
  4. Site details revised at 1 of 17 sitesv15
  5. Eligibility criteria expanded, about 45 words
    • Site details revised at 1 of 17 sites
    v14
  6. Re-verified, no change to tracked fieldsv13
  7. Site details revised at 1 of 17 sitesv12
  8. Site details revised at 1 of 17 sitesv11
  9. Site details revised at 1 of 17 sitesv10
  10. Site details revised at 2 of 17 sitesv9
  11. Site details revised at 2 of 17 sitesv8
  12. Site details revised at 2 of 17 sitesv7
  13. Site details revised at 1 of 17 sitesv6
  14. Site details revised at 1 of 17 sitesv5
  15. Study sites: 11 to 17
    • Start date changed from estimate of Aug 2023 to Aug 10, 2023
    v4
  16. Start date: Jul 2023 to Aug 2023v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2023 to Jul 2023
    • Secondary endpoints revised (9)
    • Site details revised at 11 of 11 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05826509
Lead Sponsor Institut Claudius Regaud
Collaborators: Bayer
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov