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

Piflufolastat F 18 Injection
(PYLARIFY®) is National Comprehensive
Cancer Network® (NCCN®)
Recommended (Category 2A*)10

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend piflufolastat F 18 Injection (PYLARIFY®) as an alternative to standard imaging of bone and soft tissue for:

  • Initial risk stratification for localized PCa
  • Detection of BCR disease after radical prostatectomy
  • Detection of BCR disease after radiation therapy
  • As workup for progression for evaluation of bone, pelvis, and abdomen
Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (CT, MRI) at both initial staging and biochemical recurrence, the [NCCN] Panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET
—NCCN Guidelines®
for Prostate Cancer,
V1.2022

The SNMMI Appropriate Use Criteria are also consistent with NCCN Guidelines10,11


According to SNMMI Criteria, PYLARIFY® is appropriate for men with11

  • Unfavorable intermediate, high, or very high-risk PCa
  • BCR after radical prostatectomy or radiation therapy
  • CRPC shown to be M0 on standard imaging
Checkbox icon

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed September 20, 2021. To view the most recent and complete version of the guideline, go online 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.
*Category 2A recommendations are made when based upon lower-level evidence there is uniform NCCN consensus that the intervention is appropriate.

TARGETING PSMA ENABLES PYLARIFY® PET/CT TO IMPROVE DISEASE ASSESSMENT IN PROSTATE CANCER—EVEN WHEN PSA LEVELS ARE LOW12,13†


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 rates14

PSA <2 ng/mL.

PYLARIFY® is an 18F-labeled diagnostic imaging agent for PET that targets PSMA15


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 cells2,5-7,15

PYLARIFY® uses 18F to bring greater clarity and convenience to PET/CT imaging3,8,16


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 analysis16

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 assessment16
  • 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 staff3,17

PYLARIFY® detected additional PSMA-positive lesions in 21% of patients (3 of 14) when compared to 68Ga-PSMA8


MIP with PYLARIFY® PET/CT diagnostic image

MIP with PYLARIFY®

MIP with 68Ga PSMA-11 PET/CT diagnostic image

MIP WITH 68Ga PSMA-11

Adapted with permission from 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.

Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License.

MIP with PYLARIFY®

MIP WITH 68Ga PSMA-11


PYLARIFY® clearly demonstrates several additional PSMA-positive lesions.
This patient (#12) is one of 3 patients (out of 14) for whom several additional PSMA-positive lesions were detected with PYLARIFY when compared to the 68Ga-PSMA scan8


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; NCCN=National Comprehensive Cancer Network; SNMMI=Society of Nuclear Medicine and Molecular Imaging; PCa=prostate cancer; PET=positron emission tomography; PSMA=prostate-specific membrane antigen.

INDICATION

PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent 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.

References

  1. FDA clearance letter for aPROMISE. Food and Drug Administration. July 27, 2021.
  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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed September 20, 2021. To view the most recent and complete version of the guidelines, go online to NCCN.org.
  11. Jadvar H, Calais J, Fanti S, et al. Appropriate use criteria for prostate-specific membrane antigen PET imaging. J Nucl Med. 2021;62(10):1-38.
  12. 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
  13. 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
  14. 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
  15. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
  16. 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
  17. Martiniova L, Palatis L, Etchebehere E, Ravizzini G. Gallium-68 in medical imaging. Curr Radiopharm. 2016;9(3):187-207. doi:10.2174/1874471009666161028150654