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An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.

Study acronym: ECLIPSE
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Aug 25, 2035 to Oct 25, 2035
    • Study completion date: Aug 25, 2036 to Oct 25, 2036
    • Start date changed from estimate of Sep 30, 2025 to Oct 9, 2025
    • Site details revised
    • Collaborator revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer. Flotufolastat F 18 is a radioactive tracer that binds to prostate specific membrane antigen (PSMA), a protein over-expressed on prostate tumor cells. This allows for visualization of PSMA-expressing cells upon imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes x-rays that track the body from the outside. CT images provide an exact outline of the organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. Metabolic information means how much of the injected tracer is taken up by inflammatory tissue. Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients, compared to other methods.
Trial Details
NCT Number NCT07185165
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: Blue Earth Diagnostics
Conditions
(from sponsor)
Prostate Carcinoma
Related terms Prostatic Neoplasms
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov