This phase II trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) works in diagnosing patients with prostate cancer and with rising prostate specific antigen after treatment (biochemical recurrent). Ga-68 PSMA is an imaging drug that binds to prostate tumor cells and can be imaged using PET. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT, may help find the presence of prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03396874.
PRIMARY OBJECTIVE:
I. Determine the positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga PSMA-11) PET/CT for detecting prostate cancer on a per-patient basis, confirmed by histopathology.
SECONDARY OBJECTIVES:
I. Determine sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 PET/CT for detection of tumor location confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available.
II. Determine detection rates on a per-subject basis of 68Ga PSMA-11 PET/CT stratified by prostate-specific antigen (PSA) value (0.2 - <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - < 5.0, 5.0 or greater).
III. Determine the impact of 68Ga PSMA-11 PET/CT on clinical management in patients who have prostate cancer with biochemical recurrence.
IV. Continue to evaluate safety of 68Ga-PSMA-11.
OUTLINE:
Participants receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Within 50-100 minutes, participants undergo PET/CT over 30-40 minutes.
After completion of study treatment, participants are followed up for 1 day and then up to 12 months.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorBenjamin Viglianti
