This early phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan works in detecting tumor location and size in patients with prostate cancer. 68Ga-PSMA-11 is a radioactive imaging agent that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen on their surface. A 68Ga-PSMA-11 PET/CT scan may help doctors to better detect the location, extent, and characteristics of tumor, allowing improved planning of subsequent therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03429244.
PRIMARY OBJECTIVE:
I. Define the accuracy of gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) PET-CT for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease.
SECONDARY OBJECTIVE:
I. Evaluate how knowledge of the PSMA-PET can inform treatment planning.
EXPLORATORY OBJECTIVE:
I. Generate pilot data for future larger clinical trials.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and undergo PET/CT scan along with their standard of care magnetic resonance imaging (MRI) over 60 minutes. Patients who undergo high-intensity focused ultrasound or those who are rescheduled for MRI-fusion biopsy may undergo a second gallium Ga 68-labeled PSMA-11 PET/CT scan 6-12 months later.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorClint Bahler