Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
Metastatic Prostate Cancer
About this trial
This is an interventional diagnostic trial for Metastatic Prostate Cancer focused on measuring Prostate Cancer, 11C Choline, PET Imaging
Eligibility Criteria
Inclusion Criteria:
For biochemical relapse after primary treatment
- PSA > 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on a subsequent test 3 months later
- PSA increase >2 ng/ml from nadir following radiation therapy
- PSA increase >2 ng/ml from nadir following radiation therapy plus androgen deprivation therapy with nadir defined with normalized testosterone level
- Two consecutive PSA increases from nadir level after androgen blockade or androgen suppression therapy
Kidney function with GFR > 60 mL/sec/1.73m2 and Creatinine < 1.7mg, collected within 90 days of planned scan
- if GFR is > or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast
- if GFR is < 60 mL/sec/1.73m2, PET/CT will be completed without contrast
- if Creatinine is > than 1.7 mg, Radiology will follow ACR recommendations as outlined in department policy.
- No known allergy to iodinated radiologic contrast media
- Able to have MRI based on screening evaluation. If patient is found to be MRI incompatible, the 11C-choline PET/MRI portion of the study will not be completed. Please see the provided contact numbers for further options.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Exclusion Criteria:
- ECOG Performance Status > 2.
- Concurrent malignancy, i.e. colon cancer.
- Treatment for another malignancy except superficial skin cancer within 5 years
Sites / Locations
- Decatur Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Expanded Access for 11C-Choline
11C-Choline Comparison of Modalities
The key objective of this study is to provide expanded access to this drug product as currently defined under the reference listed drug as an investigational drug in geographical service areas where 11C-choline injection is not available. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm of the study will not be further analyzed beyond that need for clinical diagnosis.
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images