18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
Summary
This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent
prostate cancer after curative-intent primary therapy and negative or equivocal findings on
standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine
PET/CT. Site clinicians will manage study subjects per standard practices and will document
any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants
will be followed for up to 6 months, with clinical data collected for this study. An
interdisciplinary panel will provide expert guidance to local readers on request. The final
reporting of the PET/CT scan will be a single report by the local reader following any such
discussion.
Phase:
Phase 3
Details
Lead Sponsor:
Blue Earth Diagnostics
Collaborators:
American College of Radiology IND 2 Results LLC Syne Qua Non Limited