RecruitingPhase 2NCT07185165

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

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


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

81 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized imaging scan (called flotufolastat F 18 PET/CT) to detect whether prostate cancer has come back or was not fully treated in men who had focal therapy (a targeted treatment that destroys only part of the prostate) within the past 6–36 months. **You may be eligible if...** - You are a man aged 18–90 with a history of prostate cancer - You received focal therapy (such as laser, cryotherapy, HIFU, or similar treatment) between 6 months and 3 years ago **You may NOT be eligible if...** - You are on hormone therapy that has lowered testosterone to very low levels - You received another investigational drug or device in the past 42 days - You cannot lie still for about 30 minutes during the scan - You have severe claustrophobia or other conditions preventing the imaging or biopsy procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComputed Tomography

Undergo PET/CT

DRUGFluorine F 18 Flotufolastat

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDUREUltrasound-Guided Prostate Biopsy

Undergo PET/CT/ultrasound fusion biopsy


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

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NCT07185165


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