About the FALCON Trial
The FALCON trial, "Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of prostate caNcer (FALCON)," is an open-label multi-center study in the U.K. designed to assess the clinical utility of fluciclovine (18F) PET imaging in the management of patients with prostate cancer with biochemical recurrence after initial treatment. The primary endpoint is to evaluate the clinical impact of fluciclovine (18F) in affecting treatment decision and is assessed by comparing records of the patient's treatment plan after a fluciclovine (18F) PET scan with the treatment plan prior to the scan. Secondary endpoints include evaluation of the effect of treatment change in patients with positive fluciclovine (18F) PET imaging findings who had a treatment change involving radical salvage therapy; diagnostic performance; PSA threshold; safety assessment and comparison with choline PET (if performed).


The FALCON trial is jointly funded by Innovate UK and Blue Earth Diagnostics and is being conducted at six leading institutions in the UK: Oxford University Hospitals NHS Foundation Trust, University College London, Kings College London, The Royal Marsden NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Mount Vernon Cancer Centre and Greater Glasgow Health Board. Additional information about the FALCON trial is available at: www.clinicaltrials.gov (NCT02578940).

U.S. Indication and Important Safety Information About Axumin*


INDICATION
Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

NOTE: Axumin (fluciclovine F 18) injection is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer.


IMPORTANT SAFETY INFORMATION
Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.

Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.

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