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Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.

Study acronym: PROSTEP-002
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Sep 1, 2025 to Nov 1, 2025v8
  2. Primary endpoints: 1 to 4
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 4
    • Secondary endpoints: 1 to 4
    v7
  3. Primary completion date: Jan 1, 2025 to Sep 1, 2025
    • Study completion date: Jun 1, 2025 to Sep 1, 2026
    • Site details revised
    v6
  4. Primary completion date: Jan 1, 2024 to Jan 1, 2025
    • Study completion date: Jun 1, 2024 to Jun 1, 2025
    v5
  5. Primary completion date: May 1, 2023 to Jan 1, 2024v4 Show 5 more changesShow less
    • Primary endpoint revised
    • Study completion date: Sep 1, 2023 to Jun 1, 2024
    • Eligibility criteria expanded, about 212 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 4, 2022 to Mar 22, 2022
    • Site details revised
    v3
  2. Start date: Jan 4, 2021 to Apr 4, 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging
Trial Details
NCT Number NCT04655365
Lead Sponsor CHU de Quebec-Universite Laval
Collaborators: Astellas Pharma Europe Ltd.
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov