Prostate cancer proves a common recurrence for many1-3

Men treated for primary prostate cancer

Pie charts showing men who experience biochemical recurrence within 10 years and develop metastatic disease within 8 years

Biochemical recurrence (BCR) rates within 10 years after common treatments1-3

  • 20% to 40% for those with radical prostatectomy

  • 30% to 50% for those with radiation

One-third of men experiencing recurrence will go on to develop metastatic disease within 8 years.2,3


Conventional imaging is not doing enough to detect recurrent prostate cancer

Salvage therapy decisions are most commonly based on4:

Clinical judgment

Probability of disease
progression

Patient and physician
preference

Risk-to-benefit profile
of each treatment

~90% of conventional images, which included computed tomography (CT), magnetic resonance imaging (MRI), and bone scans, may be negative for visualizing sites of biochemically recurrent prostate cancer5

Accurate imaging techniques are critical for clinical decision-making

Many traditional approaches still present challenges6

May not detect small tumors

Some imaging procedures may be unable to detect recurrent prostate tumors <1 cm in size or when PSA levels are <10 ng/mL—when cancer may be more effectively managed or treated with localized therapy7-12

Difficult to use

Some imaging procedures can be time-consuming or present challenges for reproducibility of results13-15

May require multiple scans to evaluate all potential metastatic sites

Bone scans, CT scans, and/or MRI may be necessary8


The precise identification of all disease sites is key to successful clinical management planning16

Axial view of inconclusive CT imaging of prostate following radical prostatectomy and negative lymphadenectomy

Inconclusive CT imaging: Axial view. Post radical prostatectomy and negative lymphadenectomy with PSA elevated to 0.73 ng/mL. MR and earlier skeletal screening were negative for malignancy.

Image courtesy of Blue Earth Diagnostics.

References:

  1. Paller CJ, Antonarakis ES. Management of biochemically recurrent prostate cancer after local therapy: evolving standards of care and new directions. Clin Adv Hematol Oncol. 2013;11(1):14-23.
  2. Darwish OM, Raj GV. Management of biochemical recurrence after primary localized therapy for prostate cancer. Front Oncol. 2012;2:48.
  3. Bruce JY, Lang JM, McNeel DG, et al. Current controversies in the management of biochemical failure in prostate cancer. Clin Adv Hematol Oncol. 2012;10:716-722.
  4. Artibani W, Porcaro AB, De Marco V, Cerruto MA, Siracusano S. Management of biochemical recurrence after primary curative treatment for prostate cancer: a review. Urol Int. 2018;100(3):251-262.
  5. Choueiri TK, Dreicer R, Paciorek A, et al. A model that predicts the probability of positive imaging in prostate cancer cases with biochemical failure after initial definitive local therapy. J Urol. 2008;179(3):906-910.
  6. Thompson IM, Valicenti RK, Albertsen P, et al. Adjuvant and salvage radiotherapy after prostatectomy: AUA/ASTRO Guideline. J Urol. 2013;190(2):441-449.
  7. Schiavina R, Ceci F, Borghesi M, et al. The dilemma of localizing disease relapse after radical treatment for prostate cancer: which is the value of the actual imaging techniques? Curr Radiopharm. 2013;6(2):92-95.
  8. Hricak H, Choyke PL, Eberhardt SC, Leibel SA, Scardino PT. Imaging prostate cancer: a multidisciplinary perspective. Radiology. 2007;243(1):28-53.
  9. Kirkham AP, Emberton M, Allen C. How good is MRI at detecting and characterising cancer within the prostate? Eur Urol. 2006;50(6):1163-1174.
  10. Wolf JS Jr, Cher M, Dall’era M, Presti JS Jr, Hricak H, Carroll PR. The use and accuracy of cross-sectional imaging and fine needle aspiration cytology for detection of pelvic lymph node metastases before radical prostatectomy. J Urol. 1995;153(3 pt 2):993-999.
  11. Merdan S, Womble PR, Miller DC, et al. Toward better use of bone scans among men with early-stage prostate cancer. Urology. 2014;84(4):793-798.
  12. Ikonen S, Kärkkäinen P, Kivisaari L, et al. Magnetic resonance imaging of clinically localized prostatic cancer. J Urol. 1998;159(3):915-919.
  13. Hegde JV, Mulkern RV, Panych LP, et al. Multiparametric MRI of prostate cancer: an update on state-of-the-art techniques and their performance in detecting and localizing prostate cancer. J Magn Reson Imaging. 2013;37(5):1035-1054.
  14. Aparici CM, Carlson D, Nguyen N, Hawkins RA, Seo Y. Combined SPECT and multidetector CT for prostate cancer evaluations. Am J Nucl Med Mol Imaging. 2012;2(1):48-54.
  15. Taneja SS. Imaging in the diagnosis and management of prostate cancer. Rev Urol. 2004;6(3):101-113.
  16. Chau A, Gardiner P, Colletti PM, Jadvar H. Diagnostic performance of 18F-fluciclovine in detection of prostate cancer bone metastases. Clin Nucl Med. 2018;43(7):e226-e231.

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.