May 15, 2017 — Blue Earth Diagnostics announced that the Trial Steering Committee recommended further recruitment be stopped in the FALCON clinical study of fluciclovine (18F) PET/CT imaging, based on successful results of a pre-planned interim analysis. The FALCON trial, announced in March 2016, is a U.K.-based, open-label study (NCT02578940) to evaluate the clinical impact of fluciclovine (18F) positron emission tomography/computed tomography (PET/CT) imaging on patient management decisions in men with biochemically recurrent prostate cancer.
In 2016, the U.S. Food and Drug Administration (FDA) approved Axumin (fluciclovine F-18), a novel molecular imaging agent for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment.
The primary endpoint of the FALCON study examines the percentage of men who have their management plan changed after a fluciclovine (18F) scan. The single, pre-planned interim analysis of the primary endpoint was performed based on the first 85 evaluable patients. Based on the interim analysis results, recruitment in the trial was to be stopped due to efficacy.
The efficacy and safety of fluciclovine (18F) to impact patient management decisions is currently under clinical investigation. Blue Earth Diagnostics plans to present results of this interim analysis of the FALCON trial at an upcoming medical congress and subsequently publish full results in a peer-reviewed publication.
“The primary aim of the U.K. multi-center FALCON trial of fluciclovine (18F) PET/CT imaging was to assess its clinical impact on treatment decisions in men with recurrent prostate cancer being considered for radical potentially curative treatment,” said Fergus Gleeson, M.D., professor of radiology, University of Oxford, Oxford, U.K., and chief investigator on the study. “Study recruitment has been stopped because of the significant numbers of changes to treatment made following the scan. In addition, we want to evaluate other criteria such as its diagnostic performance and the effect that PSA level may have on the probability of lesion detection by fluciclovine (18F).
“Biochemically recurrent prostate cancer poses an important medical challenge, as it occurs in up to one-third of men who have been previously treated, and current commercially available anatomical imaging techniques are limited in the amount of information they provide,” said Judd Moul, M.D., professor of surgery, urology, at Duke University. “Information provided by an Axumin PET scan provides useful information about the location and extent of suspected recurrent disease and has the potential to provide information to facilitate the appropriate care of men with recurrent prostate cancer.”
Blue Earth Diagnostics also announced that the LOCATE study (“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”), has completed patient enrollment earlier than anticipated. The LOCATE trial is a U.S. multi-center study designed to assess the impact on patient management of 18F fluciclovine PET imaging in patients with rising PSA after initial prostate cancer treatment. The clinical utility of 18F fluciclovine PET/CT imaging will be assessed by the change from initial to revised treatment plan.
For more information: www.blueearthdx.com