Evaluating Fluciclovine PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET

StatusActive, Not Recruiting
PhasePhase 4
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Primary and study completion dates: Jan 1, 2026 to Dec 1, 2026v9
  3. Primary completion date: Jan 1, 2025 to Jan 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Eligibility criteria revisedv6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 60 to 50v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2023 to Oct 4, 2023
    • Site details revised
    v4
  3. Primary completion date: Jul 1, 2024 to Jan 1, 2025
    • Start date: Jun 1, 2023 to Oct 1, 2023
    • Study completion date: Jul 1, 2025 to Jan 1, 2026
    v3
  4. Start date: Mar 1, 2023 to Jun 1, 2023v2 Show 5 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Mar 1, 2024 to Jul 1, 2024
    • Study completion date: Mar 1, 2025 to Jul 1, 2025
    • Secondary endpoints revised (3)
    • Study site revised
  1. Study First Submitted
  • 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 purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.
Trial Details
NCT Number NCT05722925
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Blue Earth Diagnostics, Oregon Health and Science University
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov