About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Fluorine F 18 Flotufolastat
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Ultrasound-Guided Prostate Biopsy
Procedure/SurgeryUndergo PET/CT/ultrasound fusion biopsy
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of fluorine F 18 flotufolastat (flotufolastat F 18) positron emission tomography (PET)/computed tomography (CT) in detecting residual or recurrent prostate cancer lesions
Secondary outcomes
Optimal standardized uptake value (SUV) threshold of flotufolastat F 18 PET/CT
Will establish the optimal SUV threshold of flotufolastat F 18 PET/CT that correlates with the Gleason score obtained from prostate biopsies, establishing a quantitative imaging biomarker for assessing focal therapy success.
Sponsors and contacts
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Jonsson Comprehensive Cancer Center
Lead sponsor
Blue Earth Diagnostics
Collaborator