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ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Study acronym: GETUG-AFU 40
StatusRecruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 90 to 95v9
  2. Study sites: 63 to 90 Completion date: Sep 2033 to Sep 2037 · Eligibility criteria expanded, about 32 wordsv8 Show 2 more changesShow less
    • Completion date: Sep 2033 to Sep 2037
    • Eligibility criteria expanded, about 32 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 45 to 63v7
  4. Study sites: 40 to 45 Secondary endpoints reorderedv6 Show 1 more changeShow less
    • Secondary endpoints reordered
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 40 · Start date changed from estimate of Mar 2022 to Apr 19, 2022v5 Show 2 more changesShow less
    • Study sites: 2 to 40
    • Start date changed from estimate of Mar 2022 to Apr 19, 2022
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Dec 2021 to Mar 2022 Primary completion date: Dec 2027 to Mar 2028 · Completion date: Jul 2032 to Sep 2033 · Eligibility criteria shortened, about 12 words · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Dec 2027 to Mar 2028
    • Completion date: Jul 2032 to Sep 2033
    • Eligibility criteria shortened, about 12 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Aug 2021 to Dec 2021 Primary completion date: Aug 2027 to Dec 2027 · Completion date: Feb 2031 to Jul 2032v3 Show 2 more changesShow less
    • Primary completion date: Aug 2027 to Dec 2027
    • Completion date: Feb 2031 to Jul 2032
  3. Study title shortened, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
UNICANCER
98 trials monitored
See 7 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.
Trial Details
NCT Number NCT04916613
Lead Sponsor UNICANCER
Collaborators: Bayer
Conditions Prostate Cancer Metastatic
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov