This phase I trial studies how well 18F-DCFPyL positron emission tomography (PET)/computed tomography (CT) scan works in diagnosing patients with prostate cancer that has spread to other places in the body. 18F-DCFPyL may be effective in detecting prostate cancer tissue in the body when used with PET/CT imaging techniques.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03793543.
PRIMARY OBJECTIVES:
I. Compare metastatic lesions detected on fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan, allowing for visual and quantitative assessment of stability of the lesions between the two scans. If applicable, occurrence of new lesions seen at near-term follow-up imaging will be documented.
II. Test the intraobserver agreement: the scans of every patient completing the 2 imaging time points will be reread by the same reader about 4 weeks after the first reading.
OUTLINE:
Patients receive fluorine F 18 DCFPyL intravenously (IV) at baseline. After 60 minutes, patients undergo PET/CT over 45 minutes. Patients undergo a second PET/CT between 1 and 7 days after the initial scan.
After completion of study, patients are followed up periodically.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorSteven Rowe