Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
The goal of this project is improved imaging of prostate cancer by positron emission
tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing
state-of-the-art PET/CT camera technology and processing algorithms.
A successful effort will lead to more accurate diagnosis of recurrence in patients with
prostate cancer to allow for early directed therapy. This study is designed to generate data
to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with
recurrent or persistent disease after prostatectomy or radiation therapy.
The study is designed to expand on the database of C11-Acetate PET imaging in patients with
prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post
therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET
imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.
Specific questions to be addressed:
1. What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting
recurrent disease in this patient population?
2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18
fluorodeoxyglucose (FDG-PET) and with that of CT?
3. What is the optimal imaging protocol in terms of imaging time after injection?
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
SUV (Standardized Uptake Value)
Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration
Fabio Almeida, M.D.
Medical Director, Arizona Molecular Imaging Center
United States: Food and Drug Administration
|Arizona Molecular Imaging Center||Phoenix, Arizona 85040|