September 26, 2017 -- BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced the results of a pre-planned interim analysis from an investigational clinical trial ("FALCON") evaluating the impact of fluciclovine (18F) PET/CT imaging on the clinical management of men with biochemically recurrent prostate cancer eligible for salvage therapy. The FALCON trial is a UK-based, prospective, multi-centre, open-label study (NCT02578940) to evaluate the clinical impact of fluciclovine (18F) PET/CT imaging on patient management decisions in men with biochemically recurrent prostate cancer. The primary endpoint of the FALCON study examines the percentage of men who have their management plan changed after a fluciclovine (18F) PET/CT scan. Blue Earth Diagnostics previously announced a halt to patient recruitment for the trial based on successful results of a pre-planned interim analysis.

Axumin® (fluciclovine F 18 injection) is an FDA-approved molecular imaging agent for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. It is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer. (For additional product information please see the end of this News Release.)

The FALCON trial recorded intended patient management plans prior to fluciclovine (18F) PET/CT and then recorded how they were altered once patients and their clinicians had results of the scan. Results of the interim analysis showed that 61.2% (52/85) of patients had their clinical management changed when results of fluciclovine (18F) PET/CT imaging were added to the standard-of-care diagnostic work-up. The interim results were presented in an oral presentation, "Impact of 18F-fluciclovine PET/CT on clinical management of patients with recurrent prostate cancer: results from the Phase III FALCON trial," by Eugene Teoh, MD, Oxford University Hospitals NHS Foundation Trust, at the 2017 American Society for Radiology Oncology (ASTRO) Annual Meeting, September 24 – 27, 2017.
The FALCON trial enrolled men with a biochemical recurrence of prostate cancer being considered for curative intent salvage therapy. Intended management plans were recorded prior to fluciclovine (18F) PET/CT imaging and then compared with post-scan plans. The primary endpoint examined the percentage of men who had their management plan changed after a fluciclovine (18F) scan. A single, pre-planned analysis of the primary endpoint for efficacy or futility was performed based on the first 85 evaluable patients. Based on this analysis, recruitment in the trial was stopped for efficacy. Previously planned therapeutic management was revised after a fluciclovine (18F) PET/CT scan in 61.2% (52/85) of patients. Of the 52 patients with revised treatment plans, major revisions (e.g., salvage radiotherapy to hormone deprivation or watchful waiting) were made for 59.6% (31/52) of patients. Salvage treatment was revised to watchful waiting for 25.0% (13/52) patients and to systemic therapy for 34.6% (18/52) patients, while 40.4% (21/52) patients had their previously planned radiotherapy field modified. The safety profile of fluciclovine (18F) in the FALCON trial is consistent with that described in the approved U.S. Prescribing Information.

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