This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/magnetic resonance imaging (MRI) scan and 68Ga-RM2 PET/MRI scan work in imaging patients with suspected prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET/MRI scan and 68Ga-RM2 PET/MRI scan, may help find and diagnose prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03809078.
PRIMARY OBJECTIVES:
I. To evaluate Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/MRI and Gallium Ga 68-labeled GRPR antagonist BAY86-7548 (68Ga-RM2) PET/MRI for biopsy guidance in patients with suspected prostate cancer.
EXPLORATORY OBJECTIVES:
I. Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy.
II. Correlation of 68Ga RM2 and Gleason score at biopsy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 68Ga-RM2 intravenously (IV) at baseline and then undergo PET/MRI scan over 30-60 minutes at 45 minutes post 68Ga-RM2 administration. Within 2 weeks of 68Ga-RM2 PET/MRI scan, patients receive 68Ga-PSMA11 IV and then undergo PET/MRI scan over 30-60 minutes at 45-60 minutes post 68Ga- PSMA11 administration.
ARM II: Patients receive 68Ga-PSMA11 IV at baseline and then undergo PET/MRI scan over 30-60 minutes at 45-60 minutes post 68Ga- PSMA11 administration. Within 2 weeks of 68Ga-PSMA11 PET/MRI scan, patients receive 68Ga-RM2 IV and then undergo PET/MRI scan over 30-60 minutes at 45 minutes post 68Ga-RM2 administration.
After completion of study scan, patients are followed up at 24 to 72 hours and then up to 12 months.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorAndrei Iagaru
