Dr. Shore on the Utility of PSMA PET Imaging Agent Piflufolastat F 18 for Prostate Cancer

Neal D. Shore, MD, FACS, medical director of the Carolina Urologic Research Center, discusses the clinical utility of piflufolastat F 18 (Pylarify) in identifying suspected metastasis or recurrence of prostate cancer. 

The prostate-specific membrane antigen (PSMA)–targeted PET imaging agent was approved by the FDA in May 2021. Recently, a GenesisCare site in Florida gave the first post–FDA approval scan with the product, which has been available for use in Australia and Germany for some time, according to Shore.

Data with piflufolastat F 18 has shown improved sensitivity and accuracy in targeting PSMA to identify and locate the disease, Shore explains. The phase 3 CONDOR trial (NCT03739684) and the phase 2/3 OSPREY trial (NCT029813680) were designed to establish the safety and diagnostic performance of the imaging agent across the prostate cancer disease continuum. Results from these trials demonstrated that the agent has actionable clinical utility in that it had high correct localization and detection rates, including in those with low prostate-specific antigen values, Shore notes.

The imaging agent provides an opportunity to begin the process of implementing a new and improved, next-generation imaging PET technology for patients at risk for prostate cancer throughout the United States, concludes Shore.