This phase II trial studies how well functional tests work in predicting response to drugs that inhibit the growth of new blood vessels in patients with kidney cancer that has spread to other places in the body and can be removed by surgery. Functional tests may help in monitoring the effectiveness of different treatments for kidney cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03387514.
PRIMARY OBJECTIVES:
I. To evaluate response to anti-angiogenesis therapy via fluorine F 18 DCFPyL (18F-DCFPyL) prostate-specific membrane antigen (PSMA)-based positron emission tomography (PET)/computed tomography (CT) in patients with metastatic renal cell carcinoma and to compare qualitatively with conventional imaging response criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and other histopathological endpoints including isolation, enumeration and staining of Circulating Tumor Cells (CTC).
SECONDARY OBJECTIVES:
I. Measure therapy response of patient specific uVESSEL model.
II. Evaluate the predictive power and validate the uVESSEL model.
OUTLINE:
Patients receive fluorine F 18 DCFPyL intravenously (IV) and undergo PET/CT before surgery, 4-8 weeks post-surgery and prior to start of anti-angiogenesis therapy, 12-16 weeks after start of anti-angiogenesis therapy, and at the time of disease progression or 2 years after initiation of therapy.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorSteve Yoon-Ho Cho
