Clinical guidelines support the use of 18F- fluciclovine as an imaging option for prostate cancer recurrence or progression1,3

National Comprehensive Cancer Network® (NCCN®)1

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer Version 2.20181 state that F-18 fluciclovine PET/CT or PET/MRI should be considered as options in the clinical workup of patients with recurrence or progression of their prostate cancer.

Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

Listing of National Comprehensive Cancer Network Categories of Evidence and Consensus

To view the full NCCN Clinical Practice Guidelines in Oncology in Prostate Cancer Version 2.2018, click here.

American Society of Clinical Oncology (ASCO)2

The ASCO Clinical Practice Guideline: Optimum Imaging Strategies for Advanced Prostate Cancer states that for patients with rising prostate-specific antigen (PSA) after local treatment who are considered suitable for salvage therapy, next generation imaging (NGI), including 18F-fluciclovine PET, should be considered.

To view the full ASCO Clinical Practice Guideline: Optimum Imaging Strategies, click here.

To download the guideline pocket guide, click here.

To view the the web-based pocket guide flip book, click here.

Interior pages of American Society of Clinical Oncology Clinical Practice Guideline brochure

American College of Radiology (ACR)3

The ACR Appropriateness Criteria® for Post-Treatment Follow-up of Prostate Cancer categorizes 18F-fluciclovine PET/CT skull base to midthigh as “usually appropriate” for post treatment follow up in the following situations:

  • Variant 1: Prostate cancer follow-up. Status post radical prostatectomy. Clinical concern for residual or recurrent disease.
  • Variant 2: Prostate cancer follow-up. Clinical concern for residual or recurrent disease after nonsurgical local and pelvic treatments.
  • Variant 3: Metastatic prostate cancer treated by systemic therapy (androgen deprivation therapy [ADT], chemotherapy, immunotherapy). Follow-up.

To view the full ACR Appropriateness Criteria® for Post-Treatment Follow-up of Prostate Cancer, click here.

References:

  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Guideline for Prostate Cancer (Version 2.2018). © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed 03/08/2018. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  2. Trabulsi EJ et al. Optimum Imaging Strategies for Advanced Prostate Cancer: ASCO Guideline. J Clin Oncol. 2020 Jan 15. Accessed 03/25/2020.
  3. Froemming AT, Verma S, Eberhardt SC, et al., for the Expert Panel on Urologic Imaging. American College of Radiology, ACR Appropriateness Criteria® (Post-treatment Follow-up of Prostate Cancer). © 2017 American College of Radiology. https://acsearch.acr.org/docs/69369/Narrative/. Accessed 03/01/2018.

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.