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The Phase 2/3 Emory Molecular Prostate Imaging for Radiotherapy Enhancement, or study EMPIRE-1 (NCT01666808), is the first randomized study in men with recurrent prostate cancer to demonstrate that advanced molecular imaging treatment can improve rates disease-free survival.1
The study, presented at the American Society for Radiation Oncology (ASTRO) annual meeting, used a type of PET known as fluciclovine (fluorine-18 or 18F; Axumin) invented by a multidisciplinary team at the Winship Cancer Institute of Emory University.2
“We knew that the diagnostic performance of this PET radiotracer was better than conventional imaging. We also knew that management changes,” David M. Schuster, MD, FACR, nuclear radiology specialist at the Winship Cancer Institute, said in a news release. change management in the right direction? This study allowed us to go one step further and determine if using this image affects the results for the better. And it does. “
From 2012 to 2019, 165 prostate cancer patients with detectable post-prostatectomy and negative conventional imaging were stratified by prostate specific antigen (PSA), adverse disease, and androgen deprivation therapy (ADT). One group was randomized to receive conventional imaging-based radiotherapy (n = 82) and the other group received imaging-based treatment with the fluciclovine PET radiotracer (n = 83).
Note that 1 patient in the radiotherapy arm withdrew before receiving radiotherapy. In the PET arm, 3 patients withdrew earlier and 1 patient was unable to undergo PET, however this patient received radiotherapy.
Overall, those whose treatment was adjusted based on the results of advanced molecular imaging showed an improvement in the cancer control endpoint. Furthermore, toxicity was similar in both treatment arms, suggesting that PET-guided treatment was well tolerated.
“At 3 years, the group receiving fluciclovine PET-led treatment had a 12% better cancer control rate, and this persisted even at 4 years, with a 24% improvement,” Ashesh B. Jani, MD, MSEE, FASTRO, Winship radiation oncologist and prostate cancer specialist, said in the release. “We believe the improvement has been seen because the new PET has enabled better patient selection for radiation, better treatment decisions, and better radiation target design.”
However, the researchers also indicated that integrating novel PET radiotracers into radiotherapy decisions and planning, including dose escalation to PET uptake regions, for patients with prostate cancer requires further study.
Of note, the FDA approved the use of fluciclovine in 2016 to diagnose men with recurrent prostate cancer with elevated blood levels of prostate specific antigen after previous treatment. It is the first fluorinated PET radiotracer approved by the FDA for the staging of prostate cancer.
References:
1. Jani A, Schreibmann E, Goyal S, et al. Initial report of a randomized trial comparing conventional PET / CT image-guided post-prostatectomy radiotherapy with conventional and fluciclovine (18F) for prostate cancer. Presented at the annual meeting of the American Society for Radiation Oncology (ASTRO). Abstract #: LBA 1.
2. The Winship study shows increased failure-free survival in prostate cancer [news release]. Published 23 October 2020. Accessed 23 November 2020. https://winshipcancer.emory.edu/about-us/newsroom/press-releases/2020/winship-study-shows-increased-failure-free-survival-in- prostate -cancer.html # .X7vNLRNKhH2
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