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.3-11
Not actual patients.
*Category 2A recommendations are made when based upon lower-level evidence there is uniform NCCN consensus that the intervention is appropriate.
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.
Clarify with PYLARIFY®
This combination brings superior diagnostic performance in assessing patients with suspected metastasis for initial definitive therapy† or suspected recurrence based on elevated PSA,‡ allowing you to better assess your patients' disease status.3,5,6,10
†Compared to standard anatomic images.13
‡In the setting of negative or equivocal standard imaging.14
The incidence of prostate cancer is rising and resulting mortality rates remain significant15,16
new prostate cancer cases will be diagnosed in 202315,16
deaths will occur in 2023 due to PCa, the second leading cause of cancer death in American men15,16
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 PCa12,17,18
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 32%19
Standard imaging offers limited accuracy in PCa assessment, potentially compromising therapeutic decision-making20,21
- Although bone scans and CT scans can detect bone metastases, they lack sensitivity for early lesion detection6
- Standard imaging offers limited utility in detecting recurrent lesions at PSA levels <1.0 ng/mL22
- CT scans and MRIs depend on size to detect lesions, and are therefore less likely to detect metastatic tumors between 4 mm and 8 mm6,13
- Bone remodeling in response to treatment may lead to false positives on MRI images6
PET imaging§ has the potential to improve disease localization compared to standard imaging, thus enhancing therapeutic decision-making20,21,23
§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 rate6,13
- Because up to 80% of nodal metastases in PCa are smaller than 8 mm in size, PSMA PET/CT is a promising imaging modality6
- 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/mL6
PSMA PET IMAGING IMPROVES DISEASE ASSESSMENT
which reduces the risk of undertreatment (leading to disease spread) and overtreatment (leading to unnecessary toxicity or surgery)24,25
FOR PCa IMAGING
CT=computed tomography; MRI=magnetic resonance imaging; NCCN=National Comprehensive Cancer Network; PCa=prostate cancer; PET=positron emission tomography; PSMA=prostate-specific membrane antigen.
INDICATION & IMPORTANT
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.
- Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2023.
- FDA clearance letter for aPROMISE X. Food and Drug Administration. April 29, 2022.
- PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed November 10, 2022. To view the most recent and complete version of the guidelines, 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.
- 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). J Urol. 2021;206(1):52-61. doi:10.1097/JU.0000000000001698
- 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. Clin Cancer Res. 2021;27(13):3674-3682. doi:10.1158/1078-0432.CCR-20-4573
- Key statistics for prostate cancer. American Cancer Society. Updated January 12, 2022. Accessed November 21, 2022. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
- Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708
- 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
- 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
- Cancer stat facts: prostate cancer. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed November 21, 2022. https://seer.cancer.gov/statfacts/html/prost.html
- 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
- 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
- Taneja SS. Imaging in the diagnosis and management of prostate cancer. Rev Urol. 2004;6(3):101-113.
- 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
- 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
- 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