In men suspected of recurring prostate cancer, imaging with Axumin (18F-fluciclovine) was able to accurately reveal sites of recurrence, which led to a change of treatment plans for 59 percent of the patients, topline results from the Phase 3 LOCATE trial show.
Trial findings were recently presented in a poster, “Impact of positron emission tomography with 18F-fluciclovine on management of patients with suspected recurrence of prostate cancer: results from the LOCATE trial,” at the American Urological Association Annual Meeting (AUA 2018), in San Francisco.
“We are very pleased to share these LOCATE study topline results with the prestigious urology community at AUA 2018,” Jonathan Allis, CEO of Blue Earth Diagnostics, which conducted the study, said in a press release.
“As part of our mission to develop and commercialize innovative PET imaging agents for cancer, Blue Earth Diagnostics conducted the LOCATE study in the United States to evaluate the utility of 18F fluciclovine PET/CT in providing physicians with actionable information for the management of men with recurrent prostate cancer. We plan to publish the results from the LOCATE trial in an upcoming peer-reviewed publication,” he said.
Axumin, a fluciclovine F 18 injection, is an imaging agent for positron emission tomography (PET) and computed tomography (CT) to identify suspected sites of prostate cancer recurrence in men. It is a synthetic amino acid that preferentially enters prostate cancer cells due to their increased amino acid transport, labeling them with the radioisotope F 18.
Conducted at 15 U.S. sites, the prospective, open-label Phase 3 trial (NCT02680041), enrolled 213 patients suspected of having recurring prostate cancer based on high blood levels of prostate specific antigen (PSA), a marker of the disease. The trial was aimed at evaluating how many patients changed treatment plans following an 18F fluciclovine PET/CT scan.
Researchers recorded the treatment plan for each patient prior to Axumin PET/CT and then how it was altered after the physicians reviewed the results of the scans.
Results revealed that 59% of the patients changed treatment plans after evaluation of the scans with Axumin. Of these, 78% were considered “major,” including, for instance, changes in treatment approach.
More specifically, 51% of patients, who would have been originally treated with salvage radiation therapy, had their treatment plan altered following Axumin PET/CT. Additionally, 75% of the patients who were to receive androgen deprivation therapy (ADT) changed to a nonsystemic salvage treatment after Axumin PET/CT.
“The LOCATE study evaluated men with suspected biochemically recurrent prostate cancer whose conventional imaging scans were either negative or equivocal, and compared their treatment plans before and after 18F fluciclovine PET/CT to assess whether or not it impacted their management,” said Gerald Andriole, MD, one of the study’s researchers and the Robert K. Royce Distinguished Professor and chief of urologic surgery at the Washington University School of Medicine in St. Louis.
“The results showed that management plans were revised for the majority of patients, and that 78% of such revisions involved a change in treatment modality. While investigation of the long-term clinical outcomes of these changes in management is warranted, these results indicate that decisions based on 18F fluciclovine PET/CT findings may facilitate appropriate management in men with suspected biochemical recurrence of prostate cancer,” he said.
Researchers also noted the safety profile of 18F fluciclovine in the LOCATE trial remained consistent with prescribing information already approved by the U.S. Food and Drug Administration.