NCT02680041

18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment

The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Blue Earth Diagnostics · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	18F-fluciclovine PET CT	Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-02-11
• Last updated: 2019-01-28
• Results posted: 2019-01-28

Locations

17 sites across 1 country: United States