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


Patient Demographics1

Chart listing the patient demographics for the LOCATE trial

Changes in approach for majority of patients

Overall change in management1

Overall change in management<sup>1</sup>

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

Graphic summarizing patients who were given a management plan prescan and how many were assigned to the same plan postscan

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

Line graph illustrating the Axumin PET imaging detection rate by PSA level and region

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.

 

References:

  1. 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.
  2. Data on file. Blue Earth Diagnostics, Ltd. Oxford, UK.

INDICATION

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Axumin full Prescribing Information.