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Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer

Study acronym: PEGASUS
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv14
  2. Primary completion date: Nov 6, 2023 to Aug 23, 2023
    • Study completion date: Jun 2026 to Jun 30, 2026
    v13
  3. Primary completion date changed from estimate of Jun 2024 to Nov 6, 2023
    • Study completion date: Jun 2024 to Jun 2026
    v12
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 39 of 39 sites
    v11
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 20 to 39v9
  2. Study sites: 17 to 20v8
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 3 to 17v6
  5. Study sites: 2 to 3v5
  6. Study sites: 1 to 2v4
  7. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date: Apr 2017 to Sep 25, 2017
    • Study sites: 0 to 1
    • Study completion date: Jun 2024
    • Interventions: Degarelix in combination with radiation therapy (Drug), approved GnRH agonist in combination with radiation therapy (Drug) to Degarelix (Drug), Radiotherapy (Radiation), approved GnRH agonist (Drug)
  8. Start date: Oct 2016 to Apr 2017v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy. Secondary objectives include: * documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline; * documentation of side effects and quality of life, I-PSS and urinary tract infections; * assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.
Trial Details
NCT Number NCT02799706
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 885 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov