Key Findings From the LOCATE Trial
LOCATE study design
A prospective, US, multicenter, open-label study investigating the impact of Axumin® (fluciclovine F 18) PET/CT imaging on patient management of biologically recurrent prostate cancer after initial prostate cancer treatment and after negative or equivocal findings on standard-of-care imaging.1
Primary endpoint: The percentage of men with biochemical recurrence of prostate cancer following initial prior therapy whose clinical management was changed following an Axumin PET/CT scan as recorded by completed form stating their intended management before and after the scan, with any changes recorded.1
Changes in approach for majority of patients
Overall change in management1
When presented with a negative or an equivocal scan, Axumin provides clarity for your decision-making1
Changes seen across all management options
Change in approach based on results of Axumin scan1
Change in intended treatment1
The specific treatment plan selected after the Axumin 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 Axumin 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.
Axumin detected cancer lesions even when PSA levels were ≤1.0 ng/mL
Detection rate increased as PSA level rose
Axumin-avid lesions were detected in 57% of patients (122/213) who had a negative equivocal finding on standard-of-care imaging, 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. Blue Earth Diagnostics, Ltd. Oxford, UK.