"We are very pleased to share these initial results from the FALCON study with the radiation oncology community at ASTRO," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "In line with our mission to develop and commercialize innovative PET imaging agents for cancer, the FALCON study was designed to assess the utility of a fluciclovine (18F) PET/CT scan in providing meaningful information for physicians, with the hope that it may benefit men with recurrent prostate cancer. We look forward to announcing full results of the FALCON study in a future peer-reviewed publication."

"Biochemically recurrent prostate cancer poses an important medical challenge," said Abhishek Solanki, MD, Assistant Professor of Radiation Oncology, Loyola University School of Medicine, Chicago, Ill. "Currently approved anatomical imaging procedures have limitations in identifying the sites of recurrence of prostate cancer after definitive treatment, which can make decision-making difficult when assessing patients with biochemical recurrence. Newer imaging techniques, such as fluciclovine (18F) PET/CT, may provide actionable information for physicians in guiding appropriate patient management."


"Selecting appropriate patient care options for men with biochemically recurrent prostate cancer is critical," said Judd Moul, MD, Professor of Surgery, Urology, at Duke University. "Many options are available, and some patient management plans may carry uncertainty that could potentially be alleviated by more accurate information. Clinical studies are important to investigate the role that reliable information provided by diagnostic imaging can play in guiding appropriate management for men with recurrent prostate cancer."

Blue Earth Diagnostics has also updated the status of its investigational 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"), which completed patient enrollment earlier than anticipated. Compilation of data from the 15 clinical sites is currently underway, with results planned for peer-reviewed presentation and publication next year. The LOCATE trial is a U.S. multi-center study investigating the impact on patient management of 18F fluciclovine PET/CT 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. Additional information about the LOCATE trial is available at: www.clinicaltrials.gov (NCT02680041).

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