PyL (also known as Fluorine-18-DCFPyL) is a clinical-stage, fluorinated PSMA-targeted imaging agent for the detection of prostate cancer. PSMA is the abbreviation for prostate-specific membrane antigen, a transmembrane protein that spans from the internal to the external surface of the membrane to which it is attached. These proteins exist in all kinds of prostatic tissue.
Researchers at the Center for Translational Molecular Imaging at the Johns Hopkins University School of Medicine discovered and developed PyL, which is currently included in Progenics Pharmaceuticals’ pipeline.
PyL may improve the detection of prostate cancer through medical imaging, resulting in optimal patient and disease management.
How PyL works
PyL is a second-generation fluorine-labeled small molecule targeting prostate cancer cells. It binds to specific receptors, enzymes, and proteins that become altered during the evolution of prostate cancer. After being administered, PyL circulates in the blood until it finds its target — prostate cancer cells — and then remains at the site of the disease. The radioactive fluorine serves as a signal, making it possible to obtain an image showing the location of the disease using the imaging technique positron emission tomography (PET).
PyL in clinical trials
A Phase 2/3 study called OSPREY (NCT02981368) is currently recruiting participants to evaluate the safety and diagnostic performance characteristics of PyL injection in people who are at high-risk of prostate cancer and who are planned for radical surgery to remove the prostate as well as the lymph nodes, or those with metastatic disease willing to undergo a biopsy.
The study expects to recruit 300 men in the U.S. and Canada. During the trial, PyL will be injected into the blood stream of the participants before the imaging scan.
The primary objectives of the study include the sensitivity and specificity to detect cancerous tissue in the prostate gland and to detect recurrent or metastatic prostate cancer. Secondary objectives include the sensitivity and specificity to detect prostate cancer in lymph nodes and lesion count compared to conventional imaging scans.
Previous studies confirmed that PyL is safe and accumulates in primary and metastatic prostate cancer cells. No adverse events associated with the use of Pyl have been reported so far.
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