Key Findings From the LOCATE Trial
LOCATE study design
A prospective, US, multicenter, open-label study investigating the impact of 18F fluciclovine PET/CT imaging on patient management of biologically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging. Respondents completed a form stating their intended management before and after the scan, with any changes recorded.1
Primary endpoint measured: The percentage of men with biochemical recurrence of prostate cancer following initial prior therapy whose treatment plan was changed following an 18F fluciclovine PET/CT scan.1
Axumin® (fluciclovine F 18) injection imaging led to changes in clinical management plan
126/213 (59%) had their clinical management revised after the results of Axumin PET/CT imaging were included in their diagnostic workup.1
Revisions were seen across all management plans1
The following figure summarizes the number of patients who were given a particular intended management before the Axumin scan (pre-scan) and how many were assigned to that management after the Axumin scan results were available (post-scan).
The specific treatment plan selected after the 18F fluciclovine PET/CT imaging results were available was based on the independent judgment of the study investigators, who utilized any other available confirmatory information. The clinical utility of 18F fluciclovine PET/CT to identify a particular course of treatment has not been established and clinical correlation, including potential histopathological evaluation of the suspected recurrence site, is recommended.
LOCATE image detection results
Axumin imaging detection rate by region
In LOCATE, Axumin-avid lesions were detected in 57% of patients (122/213), with 30% seen in the prostate or prostate bed and 38% outside (including 29% in lymph nodes, 2.3% soft tissues, and 11% bone).1
LOCATE Safety Data Consistent With Axumin Prescribing Information2
The safety profile of Axumin in the LOCATE trial was consistent with that described in the approved US Prescribing Information.
- Andriole GL, Kostakoglu L, Chau A, et al. The impact of positron emission tomography with 18F-Fluciclovine on the management of patients with biochemical recurrence of prostate cancer: results from the LOCATE trial. J Urol. 2019;201(2):322-331.
- Data on file. Burlington, MA. Blue Earth Diagnostics, Inc.