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PYLARIFY (18F DCFPyL) in Prostate Cancer

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
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PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans


San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc., an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics, and artificial intelligence solutions to find, fight and follow serious medical conditions, announced that PYLARIFY AI™, its recently FDA-cleared medical device software, is now commercially available in the United States.
Lantheus’ product, PYLARIFY (piflufolastat F18) injection, is the first and only commercially available and FDA-approved PSMA-targeted PET imaging agent for prostate cancer

The application of automated image analyses could improve and facilitate standardization and consistency of quantification in [18F]DCFPyL (PSMA) PET/CT scans. In the current study, we analytically validated aPROMISE, a software as a medical device that segments organs in low-dose CT images with deep learning, and subsequently detects and quantifies potential pathological lesions in PSMA PET/CT.

aPROMISE was developed to quantify and standardize assessment of PSMA PET/CT images and will support PYLARIFY® (piflufolastat F 18) adoption in the U.S.

San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc. (Lantheus) announced that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™ (automated PROstate Cancer Molecular Imaging Standardized Evaluation).

PSMA-targeted PET/CT has the potential to improve the detection and localization of prostate cancer (PCa). OSPREY was a prospective trial designed to determine the diagnostic performance of 18F-DCFPyL-PET/CT for detecting sites of metastatic PCa.

PURPOSE: Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-DCFPyL is a highly selective, small-molecule PSMA-targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of 18F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging.
Positron emission tomography (PET) using a variety of tracers can reliably detect sites of prostate cancer before abnormalities can be appreciated using conventional imaging, particularly with respect to local recurrence and metastatic disease and 68Ga labelled PSMA ([68Ga]Ga-PSMA-11) tracer is the most widely reported.1
The aim of this retrospective multicenter analysis was to assess the performance of [18F]DCFPyL prostate-specific membrane antigen (PSMA) PET/CT in the detection and localization of recurrent prostate cancer following radical prostatectomy (RP). Although the use of PSMA PET/CT in biochemical failure post-prostatectomy has been validated by international literature as being superior to conventional imaging1,2 and having a significant impact on management,2-8
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Peter R. Carroll, MD, MPH
PSMA-targeted imaging has rapidly gained interest and utilization in patients with prostate cancer. Recently, two approaches (68-Gallium and Piflufolastat F-18 [PYLARIFY, previously known as 18F-DCFPyL]) have gained FDA approval for prostate cancer patients with suspected recurrence based on elevated PSA. This is driven by a proven ability to better localize and determine the extent of recurrent disease, compared with conventional imaging approaches. 
Presented by Andrei Iagaru, MD
The AUA annual meeting included a late-breaking abstract session with a presentation by Dr. Andrei Iagaru discussing the prospective evaluation of 18F-DCFPyL PET/CT in biochemically recurrent prostate cancer and the detection of extra-pelvic oligometastases.
Presented by Steven Rowe, MD, Ph.D.
PSMA-targeted PET/CT is superior to conventional imaging modalities to localize biochemically recurrent prostate cancer after local therapy, particularly in patients with low PSA (< 2 ng/mL) values. However, few studies have reported PSMA-targeted PET/CT accuracy compared to a pre-specified rigorous standard of truth including histopathology, correlative imaging, or treatment response in this population.
Presented by Petra Lovrec, MD
Advances in imaging have dramatically reshaped prostate cancer diagnosis, staging, and treatment. While multiparametric MRI (mpMRI) of the prostate has dramatically changed prostate cancer diagnosis, molecularly-targeted imaging has reshaped disease staging and detection of recurrent disease.
Presented by Frederic Pouliot, MD, Ph.D., FRCSC,
PSMA-targeted PET/CT is superior to conventional imaging modalities to localize biochemically recurrent prostate cancer after local therapy, particularly in patients with low PSA (< 2 ng/mL) values. However, few studies have reported PSMA-targeted PET/CT accuracy compared to a pre-specified rigorous standard of truth including histopathology, correlative imaging, or treatment response in this population.
Presented by Jeremy C. Durack, MD, MS
Conventional imaging modalities including computed tomography and bone scintigraphy are routinely recommended for prostate cancer staging, however, they are limited by relatively low sensitivity and moderate specificity. In contrast, PSMA-based imaging is highly promising for prostate cancer detection, with higher sensitivity, specificity, and accuracy. 18F-DCFPyL is a novel PSMA-targeted radiopharmaceutical for positron emission tomography (PET) being explored in the staging of prostate cancer.
Presented by Preston C. Sprenkle, MD
There is no molecular imaging agent approved for the initial staging of prostate cancer. Current imaging modalities are suboptimal for the initial staging of men at risk of harboring occult metastatic prostate cancer because of the low positive and negative predictive values of pelvic CT/MRI for detecting regional nodal metastases.
Presented by Michael J. Morris, MD
Biochemical recurrence is not an infrequent occurrence following local therapy for prostate cancer, utilizing either radiotherapy or radical prostatectomy. Following biochemical relapse, patients may have disease either locally in the pelvic or more distantly.
Presented by Michael J. Morris, MD
Men with biochemically recurrent prostate cancer after definitive local therapy currently have limited imaging modalities in the United States which are sensitive or specific enough to detect tumor recurrence. PSMA PET scans can improve on this detection by detecting cells expressing PSMA protein on their cell surface.
Presented by Frederic Pouliot, MD, PhD
During the Localized Prostate Cancer: Individualizing Diagnosis, Staging, and Treatment session at the Annual ASCO GU 2020 meeting in San Francisco, CA, Dr. Pouliot presented on detection rates and the resulting impact of 18F-DCFPyL on the staging of patients with high-risk prostate cancer. Current imaging modalities are suboptimal for the initial staging or re-staging of men at risk of harboring occult metastatic prostate cancer. Because 18F-FDG PET/CT is not accurate to stage or re-stage prostate cancer, several metabolisms associated PET tracers have been developed to improve PET/CT accuracies, such as fluoro-choline and fluciclovine. 
Presented by Frederic Pouliot, MD, PhD
San Francisco, California (UroToday.com) In this oral abstract, the author presented results from Cohort A of the OSPREY trial (NCT02981368) looking at the diagnostic performance of the PSMA-PET radiopharmaceutical 18F-DCFPyL in 252 high-risk prostate cancer patients who are to undergo radical prostatectomy with lymphadenectomy. This tracer is owned by Progenics Pharmaceuticals, Inc, and is similar to other PSMA-PET radiopharmaceuticals available such as 68Ga (Gallium-68), though the 18F radioisotope may have favorable nuclear decay properties.
Presented by Frederic Pouliot, MD, PhD
The past few years have ushered several new imaging advances for patients with prostate cancer. While the standard of care in terms of radiologic staging for the vast majority of patients remains the classic CT scan and technetium-99 bone scan, a number of studies have shown improved sensitivity with novel tracers including 18-F choline, prostate-specific membrane antigen (PSMA), 18-F sodium fluoride, fluciclovine F-18, and 11-C acetate, which may be particularly useful in the setting of high risk or recurrent prostate cancer.
Presented by Michael J. Morris
Chicago, IL (UroToday.com) Accurate detection of prostate cancer is imperative to patient management, yet standard imaging methods perform poorly in accurately detecting metastatic prostate cancer. 18F-DCFPyL is a novel PET imaging agent that selectively binds to prostate-specific membrane antigen, a recognized target for prostate cancer. It is being developed for use in the initial staging of men with high-risk prostate cancer and for detection of metastatic or recurrent prostate cancer. 
Presented by Michael J. Morris, MD
PET imaging has been slowly revolutionizing the management of prostate cancer, as it has been contributing to a chance in the definition of oligometastatic disease. Able to identify small volume metastatic disease, it has forced us to question prior management options for patients with previously diagnosed cM0 disease. However, in doing so, PET imaging has also begun to make its way into other stages of prostate cancer staging and management.
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