PYLARIFY® PET/CT combines the accuracy of PET imaging, the precision of PSMA targeting, and the clarity of an 18F radioisotope2-9


PYLARIFY® (piflufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
Man with internal look at his midsection

TARGETING PSMA ENABLES PYLARIFY® PET/CT TO IMPROVE DISEASE ASSESSMENT IN PROSTATE CANCER—EVEN WHEN PSA LEVELS ARE LOW10,11*


PSMA is a validated molecular target for PCa; it is overexpressed in >90% of tumor cells7

PSMA levels have a high prognostic value; higher PSMA expression is associated with higher Gleason score and lower survival rates12

*PSA <2 ng/mL.

PYLARIFY® is an 18F-labeled diagnostic imaging agent for PET that targets PSMA1


PYLARIFY® structure
PYLARIFY® attaching to a PSMA molecule

PYLARIFY® binds to the active extracellular site of a PSMA molecule with high affinity, enabling the visualization of PCa cells rather than surrounding normal cells1,2,5-7

PYLARIFY® uses 18F to bring greater clarity and convenience to PET/CT imaging3,8,13


Fluorine-18 icon Learn more about how 18F improves image clarity

PET/CT with 18F provides superior clarity compared to 68Ga because of the lower endpoint positron energy emission, which results in a shorter distance travelled by positrons prior to annihilation, as demonstrated in a head-to-head analysis13

Chart showing positron energy spectrum for the decay of 68Ga and 18F

Positron energy spectrum for the decay of 68Ga and 18F

Monte Carlo simulation of different positron tracks from the decay of 68Ga and 18F in human lung and soft tissues

Monte Carlo simulation of different positron tracks from the decay of 68Ga and 18F in human lung and soft tissues.

  • PET/CT with 18F has higher sensitivity and better resolution than PET/CT with 68Ga, potentially facilitating more accurate interpretation and reporting of disease assessment13
  • 18F has a longer half-life than 68Ga (110 minutes versus 68 minutes), allowing for more widespread availability as well as more convenient and flexible scheduling for patients and staff3,14

SEE EFFICACY DATA
IN PATIENTS WITH
HIGH-RISK PCA WHO
WERE CANDIDATES FOR
INITIAL DEFINITIVE THERAPY

LEARN MORE

18F=radioisotope fluorine-18; 68Ga=radioisotope gallium-68; CT=computed tomography; PCa=prostate cancer; PET=positron emission tomography; PSMA=prostate-specific membrane antigen.

IMPORTANT SAFETY
INFORMATION

Contraindications

None.

Warnings and Precautions

References

  1. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company
  2. Mena E, Lindenberg ML, Turkbey IB, et al. 18F-DCFPYL PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. J Nucl Med. 2020;61(6):881-889. doi:10.2967/jnumed.119.234799
  3. Werner RA, Derlin T, Lapa C, et al. 18F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics. 2020;10(1):1-16. doi:10.7150/thno.37894
  4. Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1-14. doi:10.1177/1758835919876828
  5. Petersen LJ,  Zacho  HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review.  Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290-9
  6. Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689
  7. Ceci F, Fanti S. PSMA PET/CT imaging in prostate cancer: why and when. Clin Transl Imaging. 2019;7:377-379. doi:10.1007/s40336-019-00348-x
  8. Dietlein M, Kobe C, Kuhnert G, et al. Comparison of [18F]DCFPYL and [68Ga]Ga-PSMA-HBED-CC for PSMA-PET imaging in patients with relapsed prostate cancer. Mol Imaging Biol. 2015;17(4):575-584. doi:10.1007/s11307-015-0866-0
  9. Szabo Z, Mena E, Rowe SP, et al. Initial evaluation of [18F]DCFPYL for prostate-specific membrane antigen (PSMA)-targeted PET imaging of prostate cancer. Mol Imaging Biol. 2015;17(4):565-574. doi:10.1007/s11307-015-0850-8
  10. Pienta KJ, Gorin MA, Rowe SP, et al. A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPyL in prostate cancer patients (OSPREY) [published online ahead of print, February 26, 2021]. J Urol. doi:10.1097/JU.0000000000001698
  11. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study [published online ahead of print, February 23, 2021]. Clin Cancer Res. doi:10.1158/1078-0432.CCR-20-4573
  12. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol. 2018;8:623. doi:10.3389/fonc.2018.00623
  13. Sanchez-Crespo A. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission tomography. Appl Radiat Isot. 2013;76:55-62. doi:10.1016/j.apradiso.2012.06.034
  14. Martiniova L, Palatis L, Etchebehere E, Ravizzini G. Gallium-68 in medical imaging. Curr Radiopharm. 2016;9(3):187-207. doi:10.2174/1874471009666161028150654