Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03527199 |
Other study ID # |
1201372 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 18, 2018 |
Est. completion date |
April 10, 2023 |
Study information
Verified date |
April 2023 |
Source |
Saint Louis VA Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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
Description:
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.