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FDA approves imaging agent to aid in detection of the early spread of prostate cancer

The U.S. Food and Drug Administration (FDA) has approved the first commercially available prostate-specific membrane antigen (PSMA) imaging agent in connection with PET scans to improve the identification and management of patients with suspected metastasis of recurrent prostate cancer. 

Roughly half of the men who have been treated for prostate cancer may see a recurrence of the disease within the first decade after treatment. The disease reappearance is usually found via a rise in prostate-specific antigen (PSA) levels. But to date, imaging modalities have not been able to readily identify and localize where cancer has spread. This new agent targets the protein PSMA to aid in detecting the location of the disease.

The new imaging agent will be "available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the U.S. by year-end."

“We believe today’s approval is a game-changer for men facing prostate cancer,” said Jamie Bearse, Chief Executive Officer of ZERO – The End of Prostate Cancer, a patient advocacy group. “Having a diagnostic tool that allows doctors to see suspected metastatic or recurrent prostate cancer earlier, anywhere in the body, is a significant step forward and will have a tremendous impact on patients’ lives.”


health care & life sciences, diagnostic imaging, prostate cancer