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Results from a Pylarify AI study presented at the American Urological Association (AUA) Annual Meeting.

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Published:17th May 2022

Lantheus Holdings, Inc. presented results from a retrospective analysis of quantitative Pylarify (piflufolastat F18) PSMA (prostate specific membrane antigen) scan indices as a response imaging-biomarker to androgen deprivation therapy in veterans with newly diagnosed metastatic prostate cancer.

Using Pylarify AI to locate PSMA-avid lesions and track changes over time, investigators were able to determine that the change in the automated PSMA scan indices for total lesion volume, and also separately in bone and lymph node were all significantly consistent with PSA response following therapy. The findings support further exploration of Pylarify AI as a tool to quantify treatment response not only in at the overall disease burden but also at the lesion level.

“PSMA imaging is quickly becoming an essential tool in our management of prostate cancer and Pylarify AI has the ability to reproducibly and rapidly quantify disease burden. I think it can be used to address many limitations of conventional imaging including in the assessments of response to therapy,” said Nicholas G. Nickols, MD, PhD, Associate Professor in Radiation Oncology at UCLA, who led the study and presented the findings. “Of particular interest, this study reveals a method for measuring treatment response in bone using PSMA PET imaging, which may ultimately lead to improving patient outcomes.”

The study included a retrospective analysis of 30 treatment naïve prostate cancer patients who had undergone androgen deprivation therapy with and without radiation. PSMA scans were performed prior to treatment and at least six months after initiation of treatment. The images of all patients were analyzed by Pylarify AI which was used to locate PSMA-avid lesions and track changes over time. The continuous change in quantitative PSMA indices was compared with the change in PSA. At treatment follow-up, patients had an average PSA decline of 97% (median PSA 0.02).

Concurrently, the changes in total PSMA indices in lymph node (average decline 80%; IQR: 62% to 100%) and in bone (average decline: 51%; IQR: 14% to 87%) were found to be significantly associated with PSA decline (r=0.74; p=0.0001).

“As the use of PSMA PET imaging becomes more widespread and used to guide treatment decisions, capturing the data to produce quantifiable and reproducible insights across the treatment spectrum will be essential,” said Jean-Claude Provost, MD, Interim Chief Medical Officer, Lantheus. “This study demonstrates the power of Pylarify AI in augmenting the value of each scan and highlights the role Pylarify AI may play in assisting clinicians in determining the best path forward for treating individual patients.”

About Pylarify AI: Pylarify AI employs a deep learning algorithm that has been trained and validated across more than 3,000 images to allow healthcare professionals and researchers to perform standardized quantitative assessment of PSMA PET/CT images in prostate cancer. Through rigorous analytical and clinical studies, Pylarify AI has demonstrated improved consistency, accuracy and efficiency in quantitative assessment of PSMA PET/CT. An FDA-cleared medical device software, Pylarify AI V1.0 is commercially available in the United States.

Condition: Imaging:PET
Type: drug

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