This phase IIb/III trial studies how well 68Ga PSMA-HBED-CC positron emission tomography (PET)/computed tomography (CT) scan works in imaging patients with prostate cancer that is suspected to have come back based on elevated levels of prostate specific antigen but might not be causing disease-related symptoms (biochemical recurrence). Diagnostic procedures, such as 68Ga PSMA-HBED-CC PET/CT, may help find and diagnose prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT03822845.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Determine sensitivity on a per-subject and per-region basis of gallium 68-labeled prostate specific membrane antigen-11 N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'-diacetic acid (68Ga PSMA-HBED-CC) PET/CT for detecting tumor location, confirming with conventional imaging, clinical follow-up, and histopathology/biopsy where available.
SECONDARY OBJECTIVES:
I. Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology and conventional imaging.
II. Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology.
III. Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 < 2.0, 2.0 - < 5.0, 5.0 or greater.
IV. Continue to evaluate safety of 68Ga PSMA-HBED-CC injection as categorized by Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
EXPLORATORY OBJECTIVES:
I. Determine the impact of 68Ga PSMA-HBED-CC PET/CT on clinical management in patients who have prostate cancer with biochemical recurrence.
OUTLINE:
Patients receive Ga 68-labeled PSMA-11 intravenously (IV) and then undergo PET/CT scan at baseline. Patients may undergo a second Ga 68-labeled PSMA-11 PET/CT scan if medically indicated.
After completion of study, patients are followed up for 12 months.
Lead OrganizationUniversity of Iowa/Holden Comprehensive Cancer Center
Principal InvestigatorMichael M. Graham