The U.S. Food & Drug Administration (FDA) approved a new radioactive diagnostic agent for use in PET imaging to identify suspected sites of prostate cancer.

Axumin, developed by Massachusetts-based Blue Earth Diagnostics Ltd., is designed for use to detect prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment.

“Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products at the FDA, in a statement. “Axumin is shown to provide another accurate imaging approach for these patients.”

Two studies evaluated the safety and efficacy of the agent. The first compared 105 Axumin scans in men with suspected recurrence of prostate cancer to the histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions. Radiologists onsite read the scans initially, which were then reread by three independent radiologists read in a blinded study.

The second study evaluated the agreement between 96 Axumin and C11 choline (an approved PET scan imaging test) scans in patients with median PSA values of 1.44 ng/mL. Radiologists on-site read the scans, and the same three independent radiologists who read the scans in the first study again read the scans in this second blinded study.

The results of the independent scan readings were generally consistent with one another, and confirmed the results of the onsite scan readings. Both studies supported the safety and efficacy of the agent.