A Phase 2 interventional study of Computed Tomography and Fluorine F 18 Flotufolastat in Prostate Carcinoma, sponsored by Jonsson Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 2, Interventional, and Diagnostic
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.
PRIMARY OBJECTIVE:
I. To evaluate the accuracy of fluorine F 18 flotufolastat (flotufolastat F 18) compared with prostate biopsy to determine treatment success following focal therapy of the prostate.
SECONDARY OBJECTIVE:
I. To evaluate the standard uptake volume (SUV) threshold of flotufolastat F 18 compared to Gleason score.
EXPLORATORY OBJECTIVE:
I. To compare how flotufolastat F 18 and gallium Ga 68 gozetotide (Ga 68 PSMA 11) are distributed within the prostate in men who have previously undergone focal therapy.
OUTLINE:
Patients receive flotufolastat F-18 intravenously (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.
After completion of study intervention, patients are followed up at 1 month post-biopsy and then every 12 months for up to 10 years.
Exclusion Criteria:
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.
Procedure: Computed Tomography · Drug: Fluorine F 18 Flotufolastat · Procedure: Positron Emission Tomography · Procedure: Ultrasound-Guided Prostate Biopsy
Undergo PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Given IV
Also known as: FLOTUFOLASTAT F-18, RHPSMA-7.3C
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Undergo PET/CT/ultrasound fusion biopsy
Accuracy of fluorine F 18 flotufolastat (flotufolastat F 18) positron emission tomography (PET)/computed tomography (CT) in detecting residual or recurrent prostate cancer lesions
Time frame: Up to 10 years
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.
Time frame: Up to 10 years
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Jonsson Comprehensive Cancer Center