This phase II/III trial studies Ga 68-PSMA-11 positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors in patients with prostate cancer undergoing surgery that tend to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread. Radioactive drugs, such Ga 68-PSMA-11, binds to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02678351.
PRIMARY OBJECTIVE:
I. Sensitivity, specificity, positive and negative predictive value of gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis using nodal regional correlation.
SECONDARY OBJECTIVE:
I. Sensitivity, specificity, positive and negative predictive value of 68Ga PSMA-11 PET/MRI for the detection of extra pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow up.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
After completion of study, patients are followed up at 24-48 hours.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorAndrei Iagaru
