John Cochran VA Medical Center St. Louis
St Louis, Missouri, 63110, United States
NCT Number: NCT03527199
Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up
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Notify Me18 year–89 year
Male
Observational
St Louis, Missouri, 63110, United States
When BCR is present, detection of recurrence as well as the location, distribution and number of metastatic sites would determine the choice of subsequent management. In the search of malignancy in patients with BCR, standard of care tests include Pelvic CT or MRI (to look for recurrence and/or pelvic nodal metastases) and a planar bone scan to look for skeletal metastases. However, standard of care testing has a low diagnostic yield of only 11% of patients for visualizing sites of disease (5). Thus, there is a clear need for better imaging approaches. 18F-Fluciclovine is a synthetic amino acid PET tracer approved by the Food and Drug Administration in June of 2016 for the detection of sites of recurrence in men with rising prostate-specific antigen levels after prior primary treatment of prostate cancer (6), based on its diagnostic performance (7,8). However, there is a gap in the literature regarding prospective studies evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques. Therefore, 18F-Fluciclovine has already been approved by the FDA and covered CMS and insurance companies but is yet to be included in the NCCN guidelines in the work up of PCa patients with BCR.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
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Standard of care-Pelvic CT or MRI and MDP bone scan + or - 18F-NaF PET/CT
Time frame: 3-6months from acquiring Fluciclovine exam
Detection rate of 18F- Fluciclovine PET/CT will be compared to current standard of care imaging with or without 18F-NaF PET/CT based on all available clinical follow up data including histological reference standard when biopsy of suspected lesion(s) is performed.
Time frame: 3-6months from acquiring Fluciclovine exam
In the setting of PCa patients with BCR, documenting a higher detection rate for 18F- Fluciclovine PET/CT compared to current standard of care imaging modalities could result in future use of 18F- Fluciclovine PET/CT as a "one stop shop" for those patients.
Medhat Osman
Fed
Prospective Comparison of Pelvic CT or MRI Plus Bone Scanning With 99mTc-MDP Bone Scan and/or 18F-NaF PET/CT to 18F- Fluciclovine PET/CT in VA Prostate Cancer Patients With BCR.
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