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

National Comprehensive Cancer Network® (NCCN)®1

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer Version v2.2022 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 nonmetastatic prostate cancer.

To view the full NCCN Guidelines® for Prostate Cancer Version v2.2022, visit www.nccn.org.

The ASCO Clinical Practice Guideline2

Optimum Imaging Strategies for Advanced Prostate Cancer states that for patients with rising PSA after local treatment who are considered suitable for salvage therapy, next-generation imaging (NGI), including F 18 fluciclovine PET, should be considered if conventional imaging is negative for metastasis.

To view the full ASCO Guidelines, including pocket guide and web-based flip chart, please visit www.asco.org/research-guidelines/quality-guidelines/guidelines.

American College of Radiology (ACR)3

The ACR Appropriateness Criteria® for Post-Treatment Follow-up of Prostate Cancer categorizes Axumin PET/CT skull base to mid-thigh as “usually appropriate” for post-treatment follow-up in certain situations.*

To view the full ACR Appropriateness Criteria® for Post-Treatment Follow-up of Prostate Cancer, visit www.acr.org.

The RADAR III Group4

The group discussed the potential impact of NGIs on treatment options based on earlier detection of disease. The RADAR III Group unanimously recommended NGI techniques for select patients suspected of disease progression based on laboratory (biomarker) values, comorbidities, and symptoms and that F 18 fluciclovine PET/CT is favorable due to the combination of availability, specificity, and sensitivity.

To review the full RADAR III review article, visit www.auajournals.org/doi/pdf/10.1016/j.juro.2018.05.164.

 

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*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, and immunotherapy).

References:

  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Guideline for Prostate Cancer (Version v2.2022). © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed December 1, 2021. 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, Rumble RB, Jadvar H, et al. Optimum imaging strategies for advanced prostate cancer: ASCO guideline. J Clin Oncol. 2020;38(17):1963-1996.
  3. Expert Panel on Urologic Imaging; Froemming AT, Verma S, Eberhardt SC, et al. ACR Appropriateness Criteria® Post-treatment Follow-up Prostate Cancer. J Am Coll Radiol. 2018;15(5S):S132-S149.
  4. Crawford ED, Koo PJ, Shore N, et al. A clinician’s guide to next generation imaging in patients with advanced prostate cancer (RADAR III). J Urol. 2018;201:682-692. 

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.

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