Prostate Cancer Clinical Trials

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Eclipse: Flotufolastat F 18 to Determine Treatment Success Following Prostate Focal Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Men aged 18-90 at study enrollment

• History of prostate cancer

• Men who have had focal therapy (laser, cryotherapy, high-intensity focused ultrasound \[HIFU\], Tulsa Pro, irreversible electroporation \[IRE\], brachytherapy) within 6-36 months of enrollment

Locations
United States
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Kyla Grunden
kgrunden@mednet.ucla.edu
310-206-7576
Time Frame
Start Date: 2025-10-09
Estimated Completion Date: 2036-10-25
Participants
Target number of participants: 81
Treatments
Experimental: Diagnostic (flotufolastat F-18 PET/CT)
Patients receive flotufolastat F-18 IV. Then 50-100 minutes after injection, patients undergo whole-body PET/CT over 20-50 minutes. Patients then undergo PET/CT/ultrasound fusion biopsy within 3 months.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center
Collaborators: Blue Earth Diagnostics

This content was sourced from clinicaltrials.gov