Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities
This Phase 3 study will target approximately 100 men over age 18 who have a biochemical relapse or other evidence of relapse of prostate cancer after primary treatment.
The purpose of this study is to:
A. Provide expanded access the drug 11C-choline.
B. Determine the performance characteristics (sensitivity, specificity, positive predictive value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in patients with biochemical relapse of prostate cancer after primary treatment in a prospective manner.
C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study.
D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a multivariable analysis of clinical and pathologic data collected prospectively.
E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline PET/MRI and the combination of 11C-choline PET/CT and PET/MRI
Study Protocol:
Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.
The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.
The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer.
Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging.
Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.
Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.
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