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Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

StatusEnrolling by Invitation
PhasePhase 2/3
Started
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Record History

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  1. Notable Primary completion date: Jun 2026 to Jun 2027
    • Study completion date: Jun 2027 to Jun 2028
    v8
  2. Notable Primary completion date: Jun 2023 to Jun 2026
    • Study completion date: Jun 2024 to Jun 2027
    v7
  3. Notable Phase: Phase 3 to Phase 2/3v6
  4. Notable Primary completion date: Jun 2022 to Jun 2023
    • Study completion date: Jun 2023 to Jun 2024
    v5
  5. Minor Study title expanded, about 2 wordsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Jun 2018 to Jun 22, 2018
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.
Trial Details
NCT Number NCT03459820
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Conditions
(from sponsor)
Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov