This phase II trial studies how well an investigational scan called 18F-DCFPyL positron emission tomography/computed tomography (PET/CT) works in detecting whether prostate cancer has returned or spread to other parts of the body in men with high risk prostate cancer that has increasing prostate-specific antigen following surgery or radiation therapy (biochemically recurrent). 18F-DCFPyL contains DCFPyL, which targets and binds to PSMA proteins which are found on the surface of prostate tumor cells, and a radioactive substance, 18F, which can be detected by PET/CT scans. 18F-DCFPyL PET/CT may help find the main prostate tumor, as well as small metastatic lesions which may help more accurately diagnose and determine the disease stage and monitor therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04727736.
PRIMARY OBJECTIVE:
I. To determine the positive predictive value (PPV) of fluorine F 18 DCFPyL (18F-DCFPyL) positron emission tomography (PET) on a per-patient basis in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.
SECONDARY OBJECTIVE:
I. To determine the PPV of 18F-DCFPyL PET on a per-region basis, specifically focusing on the prostate or prostate bed, pelvis, extra pelvis, and bones.
OUTLINE:
Patients receive 18F-DCFPyL intravenously (IV) and undergo PET-CT imaging over 30-60 minutes. If a lesion is detected on the 18F-DCFPyL PET-CT scan, then patients undergo a standard of care biopsy. If the biopsy results are negative and/or the lesion is still detected in standard of care follow-up imaging, the 18F-DCFPyL PET-CT scan is repeated.
After completion of study, patients are followed up at 7 days and at 3, 6, 9 and 12 months.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorAshok Muthukrishnan
