This phase I/II trial studies how well 68Ga-PSMA-11 and 68Ga-RM2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in assessing response in patients with prostate cancer who are undergoing high intensity focused ultrasound (HIFU) local therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI, may help measure a patient's response to earlier treatment. This study is being done to see if the combination of imaging agents 68Ga-PSMA-11 and 68Ga-RM2 work better at assessing response to therapy compared to standard imaging or biopsy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03949517.
PRIMARY OBJECTIVE:
I. To determine the feasibility of gallium Ga 68-labeled PSMA-1 (68Ga-PSMA-11) PET/MRI and gallium Ga 68-labeled GRPR antagonist BAY86-7548 (68Ga-RM2) PET/MRI for evaluation of high intensity focused ultrasound (HIFU) local therapy in patients with known prostate cancer.
EXPLORATORY OBJECTIVES:
I. Comparison of 68Ga-PSMA-11 post-treatment uptake and pre-post change in uptake in response to HIFU local therapy.
II. Comparison of 68Ga-RM2 post-treatment uptake and pre-post change in uptake in response to HIFU local therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 68Ga-RM2 intravenously (IV) and undergo PET/MRI. Within 2 weeks patients also receive 68Ga-PSMA-11and undergo PET/MRI. Within 6 months after scans, patients undergo HIFU local therapy and repeat 68Ga-RM2 PET/MRI and 68Ga-PSMA-11 PET/MRI scans.
ARM II: Patients receive 68Ga-PSMA-11 IV and undergo PET/MRI. Within 2 weeks patients also receive 8Ga-RM2 IV and undergo PET/MRI. Within 6 months after scans, patients undergo HIFU local therapy and repeat 68Ga-RM2 PET/MRI and 68Ga-PSMA-11 PET/MRI scans.
After completion of study, patients are followed up within 24 to 72 hours and then periodically for up to 12 months.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorAndrei Iagaru
