This phase II/III trial studies how well 18F-DCFPyL (PyL) positron emission tomography (PET)/computed tomography (CT) works to identify prostate cancer. PyL is a radioactive drug (tracer) that targets prostate specific membrane antigen (PSMA). Because PSMA is a protein found mostly on the surface of prostate cancer cells, this trial looks to see if PyL will be able to correctly identify prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, PyL. Because some cancers take up PyL it can be seen with PET. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body. This trial is being done to see if PyL PET/CT scans can find prostate cancer tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03824275.
PRIMARY OBJECTIVE:
I. To determine the positive predictive value of fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT on a per patient basis.
SECONDARY OBJECTIVES:
I. To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones.
II. To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis.
EXPLORATORY OBJECTIVES:
I. To characterize circulating tumor deoxyribonucleic acid (ctDNA) and exosomes in patients with prostate cancer.
II. To determine correlation with ctDNA and/or exosome levels with disease burden.
OUTLINE:
Patients receive 18F-DCFPyL intravenously (IV) and then undergo PET/CT imaging over 3-5 minutes per bed position.
After completion of study, patients are followed up every 3 months.
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorMark Nathan Stein
