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

Recruiting now · Phase 2

Conditions studied: Prostate Carcinoma

In brief

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.

Key facts

Study ID: NCT07185165
Run by: Jonsson Comprehensive Cancer Center
People needed: 81
Starts: 2025-10-09
Expected to finish: 2036-10-25
Last updated by the study team: 2025-11-10

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Contraindication to flotufolastat F 18 PET CT
Contraindication to ultrasound-guided prostate biopsy
Patients who are planned to have an x-ray contrast agent or other PET radiotracer < 24 hours prior to the PET scan
Patients with castrate levels of testosterone secondary to androgen deprivation therapy
Inability to provide written informed consent
Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
Any investigational agents within 42 days prior to the day of the first dose
Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)

Where it is running

UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.