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PSMA PET/CT with PyL Reaches a Key Milestone toward Approval

“PyL PET/CT detected localized disease in most men with biochemical recurrence presenting with negative or equivocal conventional imaging, and led to changes in management in the majority of patients.”

11/02/2020
Published in Discovery - Winter 2021

It is no exaggeration to say that the work of Martin Pomper, M.D., Ph.D., Director of Nuclear Medicine and Medical Imaging, has revolutionized our ability to see tiny bits of prostate cancer anywhere in the body, and that his discoveries are actively expanding our ability to treat recurrent and metastatic prostate cancer. Pomper was the first to figure out how to engineer a small-molecule, harmless radioactive tracer to target prostate-specific membrane antigen (PSMA), a protein that lives in high concentrations on the surface of prostate cancer cells. Those tagged cells then “light up” on a PET scan to show very small areas of cancer.

The original support to develop this technique came from the Patrick C. Walsh Prostate Cancer Research Fund in 2012. Several years ago, Pomper tested the first PSMA-targeted PET agent in a clinical trial. Then he refined this into a more sensitive and specific, second-generation agent that provides sharper images, called [18F]DCFPyL (PyL).

PyL is now another step closer to FDA approval. “Current imaging techniques are inadequate for localizing and characterizing disease in men with biochemically recurrent prostate cancer, particularly in men with a low PSA (less than 2 ng/ml),” says Pomper. “But although PyL, and analogs of it, have been used in tens of thousands of patients worldwide to detect and help manage prostate cancer – to detect primary disease, metastases, and to guide focal therapy – no PSMA-targeted agent has yet garnered FDA approval in the U.S.”

Recently, PyL finished the second of two Phase 3 prospective trials, the CONDOR trial, with results presented at the 2020 meeting of The American Society of Clinical Oncology. “CONDOR met its primary endpoint,” Pomper says. PyL successfully localized sites of disease in men with biochemical recurrence – even men with low PSA levels. “PyL PET/CT detected localized disease in most men with biochemical recurrence presenting with negative or equivocal conventional (bone scan plus CT) imaging, and led to changes in management in the majority of patients. Clinicians find PSMA PET imaging useful in men with recurrent or suspected metastatic prostate cancer.”

CONDOR and an earlier trial, OSPREY, which focused on men with high-risk prostate cancer, have established the performance characteristics of PyL. A new drug application (NDA) for PyL is nearing submission as another step toward FDA approval.