San Francisco, CA ( — Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, 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)).

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.”

“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.” 

Source: WIRE, BUSINESS. 2019. “Results from Blue Earth Diagnostics’ FALCON Trial Show 64% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Following Axumin® (Fluciclovine F 18) PET/CT Scan”.

Further Related Content:
Watch: Discussion on FALCON: Impact of 18F-fluciclovine PET/CT on Clinical Management Choices for Men with Biochemically Recurrent Prostate Cancer

ASCO GU 2018: The FALCON Trial: Impact of 18F-fluciclovine PET/CT on Clinical Management Choices for Men with Biochemically Recurrent Prostate Cancer