News | Radiopharmaceuticals and Tracers | May 15, 2017

FALCON Trial of Fluciclovine PET/CT Imaging Stops Recruitment After Successful Interim Analysis

Study evaluates clinical utility of fluciclovine (18F) PET/CT imaging in men with recurrent prostate cancer following prior treatment

FALCON Trial of Fluciclovine PET/CT Imaging Stops Recruitment after Successful Interim Analysis

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

Related Content

Chest X-ray AI Algorithm Correctly Identifies Lung Disease for Dubai Health Authority
Feature | Artificial Intelligence | April 17, 2018
The Dubai Health Authority (DHA) announced the preliminary results of a chest X-ray artificial intelligence (AI)...
Novel PET Agent Could Help Guide Therapy for Brain Diseases

Rat brain 11C‐Me‐NB1 PET images (0‐60 min) superimposed on an MRI template. Credit: SD Krämer et al., ETH Zurich, Zurich, Switzerland

News | PET Imaging | April 10, 2018
Researchers have developed a new imaging agent that could help guide and assess treatments for people with various...
First Patient Treated in Online Adaptive Radiotherapy Trial With CyberKnife System
News | Stereotactic Body Radiation Therapy (SBRT) | April 06, 2018
Accuray Inc. and Erasmus MC announced the first patient has been successfully treated using an online-adaptive (OA)...
News | Endoscopes | April 02, 2018
Results from a recent prospective trial found the Wide Area Transepithelial Sampling with 3D Tissue Analysis (WATS3D)...
The Chalk River nuclear reactor license has been renewed, but will be decommissioned by 2028.

The Chalk River nuclear isotope reactor license has been renewed, but will be decommissioned by 2028. The reactor supplies about 50 percent of the world's supply of Tc99m.

Feature | Nuclear Imaging | April 02, 2018 | Dave Fornell
April 2, 2018 – The Canadian Nuclear Safety Commission (CNSC) announced March 29 that it renewed Canadian Nuclear Lab
Edwards Completes Enrollment in PARTNER 3 Low-Risk CT Sub-Study
News | Computed Tomography (CT) | March 27, 2018
March 27, 2018 — Edwards Lifesciences Corp.
Combination Radiotherapy Beneficial in Treating Prostate Cancer
News | Prostate Cancer | March 27, 2018
March 27, 2018 — While there are many treatment options for men with...
3-D Printed Models Improve Medical Student Training
News | Medical 3-D Printing | March 23, 2018
March 23, 2018 — A relatively inexpensive...
Overlay Init