EMPIRE-1 is the first randomized trial to demonstrate an improvement in failure-free survival with treatment based on advanced molecular imaging versus conventional imaging in men with recurrent prostate cancer.
Using fluciclovine (18F) PET/CT imaging to finalize treatment decisions significantly improved failure-free survival (FFS) versus administering radiotherapy based on conventional imaging (CI) alone in patients with recurrent prostate cancer.1,2
In the phase 2/3 EMPIRE-1 trial (NCT 01666808), the 3-year FFS rate was 75.5% in patients whose radiotherapy plan was finalized based on imaging with the fluciclovine PET radiotracer after an initial treatment assessment using CI. This marked a significant improvement over the 3-year FFS rate of 63% in the control arm of patients receiving radiotherapy based on CI alone (P = .003). The 4-year FFS rates were 75.5% versus 51.2%, respectively (P <.001).
According to the study investigators, EMPIRE-1 is the first randomized trial to demonstrate an improvement in FFS with treatment based on advanced molecular imaging versus CI in men with recurrent prostate cancer.
"At three years, the group getting treatment guided by PET fluciclovine had a 12% better cancer control rate, and this persisted at four years as well, with a 24% improvement," study coleader Ashesh B. Jani, MD, a radiation oncologist and prostate cancer specialist at Winship Cancer Institute of Emory University, stated in a press release. "We think the improvement was seen because the novel PET allowed for better selection of patients for radiation, better treatment decisions, and better radiation target design."
Overall, the open-label study included 165 patients with adenocarcinoma of the prostate who had cancer recurrence following prostatectomy. Patients had a detectable PSA, a negative bone scan, and CT or MRI of their abdomen/pelvis showing no evidence of extra-pelvic metastases. Patients were randomized to either radiation therapy based on conventional imaging (82 patients), or treatment guided by the fluciclovine PET radiotracer following initial CI (83 patients). Patients were randomized from 2012 to 2019. The median overall follow-up was 2.48 years.
"We knew that diagnostic performance of this PET radiotracer was better than conventional imaging. We also knew it changes management. But did it change management in the right direction? This study has allowed us to take it one step further and determine if using this imaging influences outcomes for the better. And it does," study coleader David M. Schuster, MD, a nuclear radiology specialist at Winship, stated in the press release.
According to the press release, a multidisciplinary team at Emory University invented fluciclovine (fluorine-18, or 18F), the PET used in the study. The company Blue Earth Diagnostics now commercializes fluciclovine.
"The invention and development of this imaging technology speaks to the strength of collaborative science and breadth of expertise at Winship," Walter J. Curran, Jr., MD, executive director of Winship, stated in the press release. "This study would not have been possible without Winship's comprehensive cancer center infrastructure."
1. Winship study shows increased failure-free survival in prostate cancer. Published online October 23, 2020. https://bit.ly/3dYW9yW. Accessed October 27, 2020.
2. Jani A, Schreibmann E, Goyal S, et al. Initial report of a randomized trial comparing conventional- vs conventional plus Fluciclovine (18F) PET/CT imaging-guided post-prostatectomy radiotherapy for prostate cancer. 2020 ASTRO Annual Meeting. October 24-28, 2020. LBA 1.