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Newly Approved Imaging Agent Helps Find Prostate Cancer
But not replacement for actual tissue testing, FDA says
Wednesday, September 12, 2012
WEDNESDAY, Sept. 12 (HealthDay News) -- Choline C 11, an imaging agent used for positron emission tomography (PET) testing, has been approved to help detect recurring prostate cancer, the U.S. Food and Drug Administration said Wednesday in a news release.
The injected substance helps produce an image that allows doctors to identify tissues to test for the disease, the agency said. It warned that PET testing was not a substitute for testing of the actual tissue.
PET testing is performed in men who have elevated blood levels of prostate specific antigen (PSA), a sign that prostate cancer could be present, the FDA said.
In reviewing four previously published studies, the agency said it found that "at least half" of men who had abnormalities detected in PET scans "also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas."
The FDA said side effects of the newly approved agent were limited to "an uncommon, mild skin reaction at the injection site."
The agent is manufactured and distributed by the Mayo Clinic PET Radiochemistry Facility, in Rochester, Minn.
The injected substance helps produce an image that allows doctors to identify tissues to test for the disease, the agency said. It warned that PET testing was not a substitute for testing of the actual tissue.
PET testing is performed in men who have elevated blood levels of prostate specific antigen (PSA), a sign that prostate cancer could be present, the FDA said.
In reviewing four previously published studies, the agency said it found that "at least half" of men who had abnormalities detected in PET scans "also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas."
The FDA said side effects of the newly approved agent were limited to "an uncommon, mild skin reaction at the injection site."
The agent is manufactured and distributed by the Mayo Clinic PET Radiochemistry Facility, in Rochester, Minn.
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