This trial studies how well an investigational scan called 18F-DCFPyL positron emission tomography (PET)/computed tomography (CT) works in detecting progression in patients with castration resistant prostate cancer that has spread to other places (metastatic) or has not spread to other places (non-metastatic) in the body. 18F-DCFPyL is a radioactive material, also known as a radiotracer, that is injected into the blood and detected using PET/CT scans to show the internal workings of the body. Diagnostic procedures, such as 18F-DCFPyL PET/CT, may help find and diagnose disease and find out how far the disease has spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03800784.
PRIMARY OBJECTIVES:
I. To assess the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, fluorine F 18 DCFPyL (18F-DCFPyL), in patients with metastatic castration (metastatic [m] castration-resistant prostate carcinoma [CRPC]) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (prostate specific antigen [PSA]) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients with nmCRPC receive fluorine F 18 DCFPyL intravenously (IV), and 60 minutes later undergo PET/CT over 45 minutes at baseline. Patients with negative baseline results undergo a repeat F 18 DCFPyL PET/CT at 6 months.
COHORT B: Patients with mCRPC receive fluorine F 18 DCFPyL IV, and 60 minutes later undergo PET/CT over 45 minutes at baseline and 3 months.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMark C. Markowski