Status:
COMPLETED
Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
Lead Sponsor:
Global Isotopes, LLC d/b/a Zevacor Molecular
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 t...
Detailed Description
1. The first arm of this study serves to provide expanded access to 11C-choline injection as currently defined under the reference listed drug label as an investigational drug in geographical service ...
Eligibility Criteria
Inclusion
- 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
- ECOG Performance Status \> 2.
- Concurrent malignancy, i.e. colon cancer.
- Treatment for another malignancy except superficial skin cancer within 5 years
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02260817
Start Date
October 1 2014
End Date
June 1 2018
Last Update
December 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526