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


LOCATE Trial Patient Demographics

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

59% of subjects revised management plan post-scan following Axumin injection

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).

Axumin-assisted PET scan impact on management plan

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

Axumin imaging detection rate by PSA level

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. Burlington, MA. Blue Earth Diagnostics, Inc.

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.