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.
I. To evaluate the feasibility and biodistribution of 68Ga-PSMA.
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.
- 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)
- 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