68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients with Recurrent Prostate Cancer
This trial is active, not recruiting.
|Condition||recurrent prostate carcinoma|
|Treatments||computed tomography, gallium ga 68-labeled psma ligand glu-urea-lys(ahx), laboratory biomarker analysis, magnetic resonance imaging, positron emission tomography|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2015|
|End date||June 2016|
|Trial size||10 participants|
|Trial identifier||NCT02488070, 350, NCI-2015-01067, P30CA124435, PROS0068|
This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying tumors in patients with prostate cancer that has come back after a period of improvement (recurrent). 68Ga-PSMA is a radioactive drug that may attach to specific prostate cancer cells and light up. Scanners, such as PET/CT or PET/MRI, can then be used to take pictures of the body to see where the cancer is. Using 68Ga-PSMA for PET/CT or PET/MRI may allow doctors to identify smaller tumors than standard methods.
|Endpoint classification||bio-availability study|
|Intervention model||single group assignment|
Biodistribution of gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)
time frame: After completion of imaging scan (week 1)
Number of patients who complete the examination
time frame: Up to 24 months
Male participants at least 19 years old.
Inclusion Criteria: - Provides written informed consent - Known diagnosis of prostate cancer - Patient has suspected recurrence based on biochemical data (prostate specific antigen [PSA] > 2 ng/mL) - Able to remain still for duration of each imaging procedure (about one hour) Exclusion Criteria: - Unable to provide informed consent - Inability to lie still for the entire imaging time - Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) - Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
|Official title||68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study|
|Principal investigator||Andrei Iagaru|
|Description||PRIMARY OBJECTIVES: I. To evaluate the feasibility and biodistribution of 68Ga-PSMA. OUTLINE: Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45-60 minutes later. After completion of study, patients are followed up at 24 hours and 1 week.|
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