BURLINGTON, Mass. and OXFORD, UK – September 11, 2018 – Blue Earth Diagnostics, a molecular imaging diagnostics company, announced the peer-reviewed publication of results from an investigational clinical trial ("LOCATE") evaluating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging. The LOCATE trial is a prospective, multi-center, open-label study (NCT02680041) conducted at 15 sites in the United States. Its primary endpoint measured the percentage of men with biochemical recurrence of prostate cancer following initial prior therapy whose treatment plan was changed following an 18F fluciclovine PET/CT scan.
The manuscript, "The Impact of Positron Emission Tomography with 18F-Fluciclovine on the Management of Patients with Biochemical Recurrence of Prostate Cancer: Results from the LOCATE Trial," was accepted by The Journal of Urology and is now available online: The Journal of Urology® (2018), doi:10.1016/j.juro.2018.08.050. The manuscript will also appear in an upcoming print issue.
Lead authors are Gerald L. Andriole, Washington University School of Medicine, St. Louis, Mo.; Lale Kostakoglu, The Icahn School of Medicine at Mount Sinai, New York, NY; Albert Chau, Blue Earth Diagnostics, Oxford, UK; Fenghai Duan, Brown University, Providence, RI; Umar Mahmood, Massachusetts General Hospital, Boston, Mass.; David A. Mankoff, University of Pennsylvania, Philadelphia Pa.; David M. Schuster, Emory University, Atlanta, Ga.; and Barry A. Siegel, Washington University School of Medicine, St. Louis, Mo. on behalf of the LOCATE Study Group.
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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. (For additional product information please see the end of this news release.)
The LOCATE trial prospectively evaluated 213 men with suspected recurrence of prostate cancer based on rising PSA levels (median PSA 1.00ng/mL) following previous curative-intent treatment, but with negative or equivocal findings on standard-of-care imaging. Overall, 18F fluciclovine PET/CT was positive in 57% of the evaluable patients. The study investigators used a questionnaire to document the patient's intended treatment plan prior to 18F fluciclovine PET/CT and then to record if and how that plan was altered after reviewing the results of the scan with the patient. Results of the trial indicated that 59% (126/213) of patients had their clinical management changed when results of the 18F fluciclovine PET/CT imaging were included in the diagnostic work-up. Of those changes, 78% (98/126) were classified as "major" (i.e., a change in treatment modality) and 22% (28/126) were classified as "other" (i.e., a change within a treatment modality).
