Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT03768349
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
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Notify Me18 year and older
Male
Interventional
Early Phase 1
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
Exclusion criteria
Ga-68 PSMA11 PET/CT for detection of tumor location
F-18 PSMA 1007 PET/CT for detection of tumor location
Time frame: 12 Months post PET/CT
Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
Time frame: 12 Months
Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management
Time frame: 12 Months
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Mayo Clinic
Other
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