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

NCT07185165 PHASE2 RECRUITING

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.

Details

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	PHASE2
Status	RECRUITING
Enrolment	81
Start date	Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sat Oct 25 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Prostate Carcinoma

Interventions

• Computed Tomography
• Fluorine F 18 Flotufolastat
• Positron Emission Tomography
• Ultrasound-Guided Prostate Biopsy

Countries

United States