Of 128 patients whose original treatment plan was salvage radiation therapy (with or without androgen deprivation therapy (ADT)), 51% (65/128) had their treatment changed after 18F fluciclovine PET/CT. Of 60 patients originally planned to be treated with ADT, 75% (45/60) had their treatment changed to a non-systemic salvage treatment after 18F fluciclovine PET/CT. The specific treatment plan selected after the18F fluciclovine PET/CT imaging results were available was based on the independent judgment of the study investigators, who utilized any other available confirmatory information. The clinical utility of 18F fluciclovine PET/CT to identify a particular course of treatment has not been established and clinical correlation, including potential histopathological evaluation of the suspected recurrence site, is recommended. Longer term follow-up is needed to confirm how incorporation of 18F fluciclovine PET/CT into therapy planning will affect outcomes. The safety profile of 18F fluciclovine in the LOCATE trial is consistent with that described in the approved U.S. Prescribing Information.

"We are extremely pleased that the results from the LOCATE study were so rapidly made available to the physician community through publication in the well-respected Journal of Urology," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Blue Earth Diagnostics is focused on developing and commercializing innovative PET imaging agents for cancer. In line with that mission, the U.S.-based LOCATE study evaluated the utility of 18F fluciclovine PET/CT in providing physicians with actionable information for the management of men with recurrent prostate cancer."


"The LOCATE study evaluated men with biochemically recurrent prostate cancer, who had conventional imaging scans which were either negative or equivocal, and compared their treatment plans before and after 18F fluciclovine PET/CT to assess whether or not it impacted their management," said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine in St. Louis and lead author on behalf of the LOCATE study group. "Results of the study showed that management plans were revised for 59% of patients, and that more than 75% of such revisions involved a change in treatment modality. The findings indicate that 18F fluciclovine PET/CT provides beneficial information for treatment planning in men with suspected biochemical recurrence of prostate cancer and merits further investigation of the long-term clinical outcomes following fluciclovine-guided patient management."

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