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Axumin is the First FDA Approved Fluorinated PET Radiotracer for Prostate Cancer Staging

Axumin imaging via CT scan, showing areas of cancer in red. Blue inset is the FACBC-fluciclovine compound structure.

Axumin imaging via CT scan, showing areas of cancer in red. Blue inset is the FACBC-fluciclovine compound structure.

September 2016

The FDA has approved Axumin (18F-fluciclovine or FACBC), a radiotracer for PET imaging invented and developed at Emory University, for diagnosis of recurrent prostate cancer in men who have elevated blood levels of prostate specific antigen (PSA) after previous treatment. Now being commercialized by UK-based Blue Earth Diagnostics, Ltd., Axumin is the first fluorinated radiotracer to be FDA approved for this purpose. FACBC is an abbreviation for anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid.

PET imaging that uses Axumin is expected to help doctors detect and localize recurrent prostate cancer, and could guide biopsy or the planning of additional treatment. The fluciclovine molecule in Axumin, originally developed at Emory by Mark Goodman, PhD, Professor of Radiology and Imaging Sciences, Psychiatry and Hematology and Oncology Tracer Development, and his colleague Timothy Shoup, PhD (now an Instructor in Radiology, Harvard Medical School, and an Assistant Chemist, Massachusetts General Hospital), detects the upregulation of amino acid transport that occurs in prostate cancer, and can potentially identify recurrent prostate cancer more reliably than conventional imaging techniques.

David Schuster, MD, Associate Professor and Director of the Emory Division of Nuclear Medicine and Molecular Imaging, led the clinical studies that developed Axumin for use in identifying prostate cancer in collaboration with Peter Nieh, MD, Associate Professor of Urology, Viraj Master, MD, PhD, Professor of Urology, Muta Issa, MD, Professor of Urology, Peter Rossi, MD, Associate Professor of Radiation Oncology, and Ashesh Jani, MD, Professor of Radiation Oncology.

With FDA approval established, various ongoing studies will continue working towards refining and expanding upon the capabilities of Axumin. Under the auspices of Emory's NIH-funded Prostate Cancer Biomarker Center, Principal Investigator Martin Sanda, MD, Professor and Chair of the Department of Urology, will work with Dr. Schuster and Mehrdad Alemozaffar, MD, Assistant Professor of Urology, to assess the ability of FACBC to determine the extent of prostate cancer at the initial diagnosis as well as staging in high risk prostate cancers. In this study, men with high-risk prostate cancer will undergo FACBC-PET prior to prostatectomy and robot-assisted super-extended lymphadenectomy at the time of prostatectomy to determine the accuracy of FACBC PET in detecting regional micrometastases.

To refer newly diagnosed, high-risk prostate cancer patients for consideration of Axumin-PET and superextended lymphadenectomy, contact Amra Ikic, Emory Urology Patient Care Coordinator, at 404.778.3358. To refer patients for Axumin-PET Imaging at Emory, contact Emory Radiology's Theresa Taylor, Patient Services Associate, or Wanda Hogan, Patient Access Representative, at 404.778.9729, option three, or Dawn Henry, RN, BSN, Prostate Cancer Care Navigator of Winship Cancer Institute, at dawnsherie.henry@emoryhealthcare.org, 678.843.5665.

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