BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, today announced results from an investigational clinical trial (“FALCON”) evaluating the impact of 18F-fluciclovine 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-center, open-label study (NCT02578940). Its primary endpoint examined the percentage of men who had their management plan changed after an 18F-fluciclovine PET/CT scan.
Axumin® (fluciclovine F 18) injection is approved 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. (For additional product information please see the end of this news release.)
Investigators in the FALCON trial recorded intended patient management plans prior to 18F-fluciclovine PET/CT imaging and then recorded how the plans were altered following review of the scan results. Results of the trial indicated that 64% (66/104) of patients had their clinical management plan changed when results of 18F-fluciclovine PET/CT imaging were added to the standard-of-care diagnostic work-up. Of those changes, 65% (43/66) were classified as “major,” denoting a change in treatment modality (e.g. salvage radiotherapy to androgen deprivation therapy (ADT)).
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Results from the study were summarized in an oral presentation, “Impact of positron emission tomography (PET) with 18F-fluciclovine PET/CT on management of patients with recurrence of prostate cancer: results from the FALCON trial,” by David Bottomley, MBBS, St. James Institute of Oncology, Leeds UK, at the 2019 American Society for Radiology Oncology (ASTRO) Annual Meeting, September 15 – 18, 2019.
“We are very pleased to share results from the FALCON study with the radiation oncology community at ASTRO and look forward to publishing the results in an upcoming peer-reviewed journal,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “As part of our mission to develop and commercialize innovative PET imaging agents for cancer, Blue Earth Diagnostics conducted the FALCON and LOCATE studies to evaluate the utility of a 18F-fluciclovine PET/CT scan in providing physicians with actionable information for the management of men with recurrent prostate cancer. Each of these two independent, prospective studies arrived at similar conclusions - that 18F-fluciclovine PET/CT located recurrent disease in the majority of men in the study, which frequently resulted in major changes to their management plans for biochemical recurrence.”