The FDA has approved Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent, for use in men with recurrent prostate cancer to help locate specific body sites for follow-up tissue sampling and testing.
Choline C 11 injection is indicated for use in patients with elevated prostate specific antigen (PSA) levels after earlier treatment for prostate cancer, and is not intended as a replacement for tissue testing and sampling, the agency said in a press release.
The agent is manufactured by the Mayo Clinic PET Radiochemistry Facility — the first FDA-approved PET manufacturing facility in the United States that complies with FDA Modernization Act regulations — and must be administered to patients shortly after production.
“Choline C 11 Injection provides an important imaging method to help detect the location of prostate cancer in patients whose blood tests suggest recurrent cancer when other imaging tests are negative,” Charles Ganley, MD, director of the FDA’s Center for Drug Evaluation and Research Office of Drug Evaluation IV, said in a statement.
Currently, conventional imaging with computed tomography (CT) scans does not always detect recurrent prostate cancer even when PSA levels are elevated, the FDA noted.
The agency approved Choline C 11 Injection after data from a metaanalysis of four independent studies involving a total of 98 patients with elevated PSA levels, but no signs of recurrent prostate cancer on CT scans, showed at least half the patients who had abnormalities detected on PET scans, also had recurrent prostate cancer.
However, false positives were observed in 15% to 4% of study participants who underwent Choline C 11 Injection PET scans, depending on the study, emphasizing the importance of confirmatory tissue sampling for abnormalities detected PET scans. The only adverse events noted with Choline C 11 were mild injection site reactions.