This phase II trial studies how well fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) imaging works in detecting high-grade prostate cancer in patients with elevated prostate-specific antigen (PSA) levels. A PET scan uses radioactive material, also known as a radiotracer, injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. Fluorine F 18 DCFPyL is a radioactive tracer, which when used with combined PET/CT imaging, may help doctors more accurately locate areas of high grade prostate cancer in patients with elevated PSA.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03471650.
PRIMARY OBJECTIVE:
I. To compare the diagnostic accuracy of 18F-DCFPyL (fluorine F 18 DCFPyL) PET/CT with serum PSA for detecting clinically significant prostate cancer (defined as Gleason score >= 3+4=7 prostate cancer) on prostate biopsy.
SECONDARY OBJECTIVES:
I. To compare the diagnostic accuracy of 18F-DCFPyL PET/CT with serum PSA for detecting clinically significant prostate cancer as defined by the following alternative definitions: Gleason score >= 4+3=7; Gleason score >= 3+4 or > 50% involvement of >= 1 core with Gleason score >= 3+3= 6 prostate cancer; Gleason score >= 3+4 or > 70% involvement of >= 1 core with Gleason score >= 3+3= 6 prostate cancer; Gleason score >= 3+4= 7, or > 2 cores with Gleason score >= 3+3= 6, or > 50% involvement of >= 1 core with Gleason score >= 3+3= 6 prostate cancer; and Gleason score >= 4+3= 7 or intermediate to high risk prostate cancer as determined by the Oncotype DX Genomic Prostate Score assay (Genomic Health, Redwood City, CA).
II. To compare the diagnostic accuracy of 18F-DCFPyL PET/CT with multiparametric magnetic resonance imaging (mpMRI) for detecting clinically significant prostate cancer by the various tested definitions.
III. To compare the diagnostic accuracy of 18F-DCFPyL PET/CT with the phi test for detecting clinically significant prostate cancer by the various tested definitions.
IV. To evaluate for potential renal / genitourinary tract toxicity from administration of the 18F-DCFPyL radiotracer by comparing results on pre- and post- dosing urinalysis testing.
EXPLORATORY OBJECTIVE:
I. To repeat the primary and secondary analyses that pertain to diagnostic accuracy using novel PET radiomic features.
OUTLINE:
Patients receive fluorine F 18 DCFPyL intravenously (IV) on day 1. Patients also undergo PET/CT imaging 60-120 minutes after fluorine F 18 DCFPyL administration. Patients then undergo prostate biopsy between days 2 and 28 after receiving fluorine F 18 DCFPyL and PET/CT imaging.
After completion of study intervention, patients are followed up between 7 and 10 days.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMohamad E. Allaf
