PyL Imaging Agent Accurately Detects Recurrent Prostate Cancer Lesions, Trial Shows

PyL Imaging Agent Accurately Detects Recurrent Prostate Cancer Lesions, Trial Shows
Progenics Pharmaceuticals’ PyL, a new imaging agent for positron emission tomography (PET) scans, can accurately detect the location of recurrent prostate cancer lesions, according to data from a Phase 3 clinical trial. “The positive results of our Phase 3 CONDOR trial reinforce our belief in the potential of PyL to enable better physician treatment decisions and, ultimately, improve patient outcomes,” David Mims, Progenics’ interim CEO, said in a press release. The company plans to submit a new drug application for PyL to the U.S. Food and Drug Administration in the second half of this year, according to Mims. “There is a need for improved diagnostics for prostate cancer to replace conventional imaging tests that have limited performance characteristics, especially in men with biochemical recurrence of their disease,” said Barry Siegel, MD, CONDOR’s principal investigator at the Mallinckrodt Institute of Radiology at Washington University School of Medicine clinical site. PyL (18F-DCFPyl) is a tracing agent composed of DCFPyL, a small molecule that specifically targets the prostate specific membrane antigen (PSMA) protein — present at high levels in prostate cancer cells — coupled with a radioactive substance called fluorine F 18. After PyL is injected intravenously into the patient, it travels through the blood and accumulates at prostate cancer sites, making them “light up” during PET scans. PyL has the potential to allow clinicians to detect very small lesions that are currently missed with conventional imaging methods, so can they determine if the disease has returned or spread to distant organs and adjust treatment plans accordingly. The open-label CONDOR study (NCT03739684) evaluated whether PyL could safely, succe
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