The Lancet Publishes Results of Axumin® (Fluciclovine F 18) PET Imaging Study Demonstrating Improved Patient Outcomes in Patients with Recurrent Prostate Cancer

Excerpt from the Press Release:

BURLINGTON, Mass. & OXFORD, England–(BUSINESS WIRE)–Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, is pleased to share news of the publication of a study from researchers at Winship Cancer Institute of Emory University (Winship) evaluating Axumin® (fluciclovine F 18) PET imaging in men with recurrent prostate cancer. The randomized, prospective study showed that Axumin-guided post-prostatectomy radiation therapy increased biochemical event-free survival rates in men with recurrent disease. Among 165 patients whose prostate cancer had returned following surgical removal of their prostate, 75.5% whose treatment integrated Axumin PET imaging were event-free after three years, compared to 63% for whom only conventional imaging techniques were used to plan treatment. The increased event-free survival rate persisted after four years of follow-up, at 75.5% vs. 51.2%, respectively. Provider-reported genitourinary or gastrointestinal side effects were similar between the two study groups. Axumin, a novel amino acid-based radiopharmaceutical, is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

The manuscript, “EMPIRE-1: Randomized Trial Comparing Conventional- vs Conventional plus Fluciclovine (18F) PET/CT Imaging-Guided Post-Prostatectomy Radiotherapy for Prostate Cancer,” was published online in The Lancet on May 7, 2021 (DOI: https://doi.org/10.1016/S0140-6736(21)00581-X). The manuscript will also appear in an upcoming print issue. The EMPIRE-1 (Emory Molecular Prostate Imaging for Radiotherapy Enhancement) trial (NCT01666808) is the first randomized trial of men with recurrent prostate cancer to show that treatment based on advanced molecular imaging with ¹⁸F-fluciclovine PET can improve event-free survival rates. The Phase 2/3 trial was led by Winship radiation oncologist and prostate cancer specialist, Ashesh B. Jani, MD, MSEE, FASTRO, and Winship nuclear medicine specialist David M. Schuster, MD, FACR.

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