This phase III trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in diagnosing patients with prostate cancer and with rising prostate specific antigen after treatment. Ga-68 PSMA is an imaging drug that binds to prostate tumor cells and can be imaged using PET. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT or PET/MRI, may help find the presence of prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03353740.
PRIMARY OBJECTIVES:
I. Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
SECONDARY OBJECTIVES:
I. Positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
II. Sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
III. Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0).
IV. Impact of 68Ga-PSMA-11 PET on clinical management in BCR patients.
V. Inter-reader reproducibility.
VI. Safety, as characterized by Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. Within 50-100 minutes, patients undergo PET/CT over 30-40 minutes or PET/MRI over 50-60 minutes.
After completion of study, patients are followed up at day 1 and then up to 12 months.
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorThomas A. Hope