This phase II trial studies how well 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI works for the treatment of patients with low-risk and intermediate-risk prostate cancer scheduled for high-dose rate brachytherapy. Diagnostic procedures, such as 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI, may help find and diagnose prostate cancer and assess response to therapy. This study may help researchers determine if the combination of imaging agents 68Ga RM2 and 68Ga PMSA11 work better in assessing response to therapy than standard imaging or biopsy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04264208.
PRIMARY OBJECTIVES:
I. To demonstrate that gallium Ga 68-labeled GRPR antagonist BAY86-7548 (68Ga-RM2) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/magnetic resonance imaging (MRI) can detect additional cancers over multi parametric (mp)MRI.
II. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict PFS at 24 months.
OUTLINE: Patients are randomized to 1 of 2 schedules.
SCHEDULE A: Patients receive 68Ga PSMA-11 intravenously (IV) and undergo PET/MRI over 30-60 minutes. Within 2 weeks, patients then receive 68Ga-RM2 IV and undergo PET/MRI. Patients then undergo high-dose rate (HDR) brachytherapy. Beginning 3 days after HDR, patients receive 68Ga PSMA-11 IV and undergo PET/MRI. Within 2 weeks, patients then receive 68Ga-RM2 IV and undergo PET/MRI.
SCHEDULE B: Patients receive 68Ga-RM2 IV and undergo PET/MRI. Within 2 weeks, patients then receive 68Ga PSMA-11 IV and undergo PET/MRI. Patients then undergo HDR brachytherapy. Beginning 3 days after HDR, patients receive 68Ga-RM2 IV and undergo PET/MRI. Within 2 weeks, patients then receive 68Ga PSMA-11 IV and undergo PET/MRI.
After completion of study treatment, patients are followed up at 24-72 hours and then for 12 months.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorAndrei Iagaru
