2. UroToday Home
  3. Conference Highlights
  4. ASCO GU 2019
  5. ASCO GU 2019 Press Releases

ASCO GU 2019

Blue Earth Diagnostics Announces Axumin® (Fluciclovine F 18) LOCATE Study Presentation at Upcoming ASCO 2019 Genitourinary Cancers Symposium on Impact on Clinical Management of Recurrent Prostate Cancer

San Francisco, CA USA (UroToday.com) -- Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced the upcoming presentation of additional analyses from the LOCATE clinical trial (NCT02680041). The LOCATE trial is a prospective, U.S., multicenter, open-label study investigating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging. The presentation will be made at the ASCO 2019 Genitourinary Cancers Symposium (ASCO GU), from February 14-16, 2019 in San Francisco, Ca. Details of the presentation to be given by Blue Earth Diagnostics collaborators is listed below.

Date: Thursday, February 14, 2019
Presentation:
Identification of bone involvement in patients with prostate cancer recurrence using 18F-fluciclovine PET/CT and impact on subsequent management
Abstract Number: 248
Presenter: Michael S Kipper, MD, Genesis Healthcare, on behalf of the LOCATE study group
Session Title & Times: Poster Session A: Prostate Cancer, 11:30 AM-1:00 PM and 5:30 PM-6:30 PM PT
Location: Moscone West Building, San Francisco, Ca.

Blue Earth Diagnostics invites participants at the ASCO Genitourinary (GU) Cancers Symposium 2019 to attend the above presentation and to learn more about the company at Exhibit 36.

U.S. Indication and Important Safety Information About Axumin

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.
Full Axumin prescribing information is available at www.axumin.com.


Further Related Content:
ASCO GU 2019 Coverage Coming Soon