Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
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:
1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.
2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.
3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic
prostate cancer.
4. 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.
5. Rates of confirmed metastasis between conventional CT and MRI images will be compared
with the 11C-choline PET CT and MRI images.
6. 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.