This pilot clinical trial studies how well 68Ga PSMA-HBED-CC positron emission tomography/computed tomography (PET/CT) works in imaging patients with prostate cancer that has spread to other parts of the body. Diagnostic procedures, such as 68Ga PSMA-HBED-CC PET/CT, may help find and diagnose metastatic prostate cancer and find out how far the disease has spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02952469.
PRIMARY OBJECTIVES:
I. Determine the biodistribution, quantitative time course, and the range of uptake in normal organs using gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx] ([68Ga]Glu-urea-Lys(Ahx)-HBED-CC) (68Ga prostate specific membrane antigen [PSMA]-HBED-CC) positron emission tomography (PET) in patients with metastatic castrate resistant prostate cancer.
II. Analyze reproducibility of 68Ga PSMA-HBED-CC PET uptake in target tumors and normal tissues.
SECONDARY OBJECTIVES:
I. To corroborate radiopharmaceutical radiation dosimetry estimates found in the literature.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) intravenously (IV) on day 0. Beginning 60 minutes after injection, patients undergo PET/CT for about 30-40 minutes on day 0. Within 1-15 days, patients undergo a second gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) PET/CT.
After completion of study, patients are followed at 24 hours and and then within 3 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Iowa/Holden Comprehensive Cancer Center
Principal InvestigatorJanet Pollard