“The FALCON study evaluated men with biochemically recurrent prostate cancer who were being considered for curative-intent salvage therapy, and compared their treatment plans before and after 18F-fluciclovine PET/CT imaging to assess whether or not it impacted their management,” said David Bottomley, MD, St. James Institute of Oncology, Leeds UK. “Results indicated that management plans were revised for the majority of patients, with 65% of revisions involving a major change in treatment modality. These results indicate that decisions based on 18F-fluciclovine PET/CT findings may facilitate more personalized management in men with biochemically recurrent prostate cancer. Investigation of the long-term clinical outcomes of these changes in management is warranted.”

The primary endpoint of the FALCON trial examined the percentage of men who had their management plan changed following an 18F-fluciclovine scan. Previously planned therapeutic management was revised after an 18F-fluciclovine PET/CT scan in 64% (66/104) of patients. Of the patients with revised treatment plans, major revisions (e.g., salvage radiotherapy to hormone deprivation or watchful waiting) were made for 65% (43/66) of patients. Salvage treatment was revised to watchful waiting for 24% (16/66) patients and to systemic therapy for 24% (16/66) patients, and 17% (11/66) experienced alternative changes to their treatment modality. Of the patients with revised treatment plans, 35% (23/66) had their intended radiotherapy/brachytherapy plans modified. The safety profile of 18F-fluciclovine in the FALCON trial is consistent with that described in the approved U.S. Prescribing Information.


“Between 30 – 40% of patients with prostate cancer will develop local or distant recurrences within 10 years of radical prostatectomy or radiation therapy, underscoring the need for accurate information on the extent and location of recurrent disease,” said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine and lead author on behalf of the LOCATE study group. “Results of the FALCON study are consistent with those of the U.S., multi-center LOCATE study of 213 patients, which demonstrated that 59% of men with recurrent prostate cancer following prior treatment had a change in their management plan after 18F-fluciclovine PET/CT imaging.”


About the FALCON Trial
The FALCON trial, “Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of prostate caNcer (FALCON),” was an open-label, multi-center study in the UK designed to assess the clinical utility of 18F-fluciclovine PET imaging in the management of patients with prostate cancer with biochemical recurrence after initial treatment. The primary endpoint was to evaluate the clinical impact of 18F-fluciclovine in affecting treatment decisions and was assessed by comparing records of the patient’s treatment plan after an 18F-fluciclovine PET scan with the treatment plan prior to the scan. Secondary endpoints included evaluation of the optimal PSA threshold for detection, salvage treatment outcome assessment based on 18F-fluciclovine involvement and safety.

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