When assessing patients with suspected prostate cancer metastasis who are candidates for
initial definitive therapy or suspected recurrence based on elevated PSA,

PYLARIFY® reveals The clearer Picture.2-10

Not actual patients.

Piflufolastat F 18 Injection (PYLARIFY®)

NCCN Category 2A*


NCCN=National Comprehensive Cancer Network.
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.

Clarify with PYLARIFY®

  • PET imaging icon


  • PSMA targeting icon


  • Fluorine-18 icon


  • Artificial Intelligence icon


This combination brings superior diagnostic performance in assessing patients with suspected metastasis for inital definitive therapy or suspected recurrence based on elevated PSA, allowing you to better assess your patients’ disease status.2,4,5,9

Compared to conventional anatomic images.12
In the setting of negative or equivocal standard imaging.13

PYLARIFY® data icon

See PYLARIFY® data in patients with high-risk PCa who were candidates for initial definitive therapy

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See trial results in patients with biochemically recurrent prostate cancer

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Case Studies

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from clinical trials

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The incidence of prostate cancer and
resulting mortality rates are rising14,15

Approximately 248,530 new prostate cancer cases will be diagnosed in 2021

new prostate cancer cases will be diagnosed in 202114,15

Approximately 34,130 PCa deaths will occur in 2021

deaths will occur in 2021 due to PCa, the second leading cause of cancer death in American men14,15

Accurate initial assessment of a patient’s disease is critical because high-risk PCa is more likely to be advanced at diagnosis and/or relapse than low-risk PCa11,16,17

5-year relative survival rate for patients diagnosed with localized prostate cancer approaches 100%, however, if distant metastasis is present at the time of diagnosis, the 5-year survival rate has been reported to be 30%18

5-year survival rates of localized, regional, and distant prostate cancer
PET/CT scan icon

Conventional imaging offers limited accuracy in PCa assessment, potentially compromising therapeutic decision-making19,20

  • Although bone scans and CT scans can detect bone metastases, they lack sensitivity for early lesion detection5
  • Conventional imaging offers limited utility in detecting recurrent lesions at PSA levels <1.0 ng/mL21
  • CT scans and MRIs depend on size to detect lesions, and are therefore less likely to detect metastatic tumors between 4 mm and 8 mm5,12
  • Bone remodeling in response to treatment may lead to false positives on MRI images5

PET imaging§ has the potential to improve disease localization compared to conventional imaging, thus enhancing therapeutic decision-making19,20,22

§With an appropriate tracer and combined with CT or MRI.

  • PSMA PET/CT can detect lesions between 4 mm and 8 mm, and therefore has a higher detection rate5,12
    • Because up to 80% of nodal metastases in PCa are smaller than 8 mm in size, PSMA PET/CT is a promising imaging modality5
  • PSMA PET/CT is also effective at lower PSA levels; the rate of detection of nodal metastases has been reported to be 46% when PSA was <0.2 ng/mL5


which reduces the risk of undertreatment (leading to disease spread) and overtreatment (leading to unnecessary toxicity or surgery)23,24


CT=computed tomography; MRI=magnetic resonance imaging; NCCN=National Comprehensive Cancer Network; PCa=prostate cancer; PET=positron emission tomography; PSMA=prostate-specific membrane antigen.


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.


  1. FDA approval letter for aPROMISE. Food and Drug Administration. July 27, 2021.
  2. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
  3. 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
  4. 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
  5. 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
  6. 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 
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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.
  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. Key statistics for prostate cancer. American Cancer Society. Updated January 12, 2021. Accessed February 25, 2021. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
  15. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33. doi:10.3322/caac.21654
  16. Wang Z, Ni Y, Chen J, et al. The efficacy and safety of radical prostatectomy and radiotherapy in high-risk prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2020;18(1):42. doi:10.1186/s12957-020-01824-9
  17. Chang AJ, Autio KA, Roach M 3rd, Scher HI. High-risk prostate cancer-classification and therapy. Nat Rev Clin Oncol. 2014;11(6):308-323. doi:10.1038/nrclinonc.2014.68
  18. Cancer stat facts: prostate cancer. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed February 19, 2021. https://seer.cancer.gov/statfacts/html/prost.html
  19. Hofman MS, Lawrentschuk N, Francis RJ, et al; proPSMA Study Group Collaborators. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395(10231):1208-1216. doi:10.1016/S0140-6736(20)30314-7
  20. Rousseau E, Wilson D, Lacroix-Poisson F, et al. A prospective study on 18F-DCFPYL PSMA PET/CT imaging in biochemical recurrence of prostate cancer. J Nucl Med. 2019;60(11):1587-1593. doi:10.2967/jnumed.119.226381
  21. Taneja SS. Imaging in the diagnosis and management of prostate cancer. Rev Urol. 2004;6(3):101-113.
  22. Li R, Ravizzini GC, Gorin MA, et al. The use of PET/CT in prostate cancer. Prostate Cancer Prostatic Dis. 2018;21(1):4-21. doi:10.1038/s41391-017-0007-8
  23. Park SY, Zacharias C, Harrison C, et al. Gallium 68 PSMA-11 PET/MR imaging in patients with intermediate- or high-risk prostate cancer. Radiology. 2018;288(2):495-505. doi:10.1148/radiol.2018172232
  24. Gorin MA, Rowe SP, Patel HD, et al. Prostate specific membrane antigen targeted 18F-DCFPYL positron emission tomography/computerized tomography for the preoperative staging of high risk prostate cancer: results of a prospective, phase II, single center study. J Urol. 2018;199(1):126-132. doi:10.1016/j.juro.2017.07.070