(RxWiki News) For some patients, prostate cancer can reappear after surgery or treatment. The FDA recently approved an imaging agent that can help find the tissue where the cancer has returned.
Studies have shown that an imaging technique called positron emission tomography, or PET scanning, can pinpoint cancerous tissue.
The U.S. Food and Drug Administration recently approved the production of Choline C 11, an agent used for PET testing. The Mayo Clinic in Rochester, Minnesota is the first FDA-approved facility to produce Choline C 11 Injection.
"Ask your doctor about prostate cancer screening."
Men diagnosed with prostate cancer may have the entire prostate gland and/or surrounding tissue removed.
According to the Prostate Cancer Foundation, about 20 to 30 percent of men begin to show signs of disease recurrence within five years of treatment.
Doctors typically use a blood test to monitor patients who have had prostate treatment. The test checks levels of prostate-specific antigen or PSA. High PSA levels mean that the cancer may have come back.
The recently approved Choline C 11 is a radioactive substance. The low levels of radioactivity do not harm the body, but a PET scanner can detect the gamma rays emitted.
Doctors give patients a Choline C 11 injection. The element is taken up into cancerous cells so those cells can be seen by the PET scanners. Doctors can then sample the identified cells and test them for cancer.
“The FDA’s approval of Choline C 11 Injection at the Mayo Clinic provides assurance to patients and health care professionals they are using a product that is safe, effective, and produced according to current good manufacturing practices,” said Charles Ganley, MD, director of the Office of Drug Evaluation IV in FDA’s Center for Drug Evaluation and Research.
The FDA verified the safety and effectiveness of the Choline C 11 Injection through a systematic review of published study reports.