Late in the 1980s and 1990s, some evidence from epidemiologic studies had suggested that people who take non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief have a reduced risk of colon cancer, and more recent studies have suggested that this reduced risk may be true for prostate cancer, as well.

These drugs, which include aspirin, block Cox-2, which is produced in response to injury and enhances the inflammatory response, resulting in pain, inflammation and swelling. But NSAIDs also block expression of Cox-1, which is produced constantly and helps preserve the stomach's lining. Hence the increased risk of gastrointestinal side effects associated with taking NSAIDs.

The advent in 1998 of celecoxib, first of the two cyclooxygenase-2 specific (Cox-2) inhibitor drugs approved by the U.S. Food and Drug Administration, provided the same effectiveness against pain and swelling of inflammation as the older NSAIDs but without the increased gastrointestinal risk, including stomach ulcers. These drugs are sold in the United States under the brand names Celebrex and Vioxx.

In a clinical study, people at hereditarily high risk for developing pre-cancerous colon polyps were given celecoxib. They showed a decrease in the number of these polyps. Consequently, the FDA has approved the use of celecoxib for the prevention of pre-cancerous polyps in these patients.

"We think Cox-2 inhibitors may help delay or prevent disease progression in men with recurrent prostate cancer after definitive radiation therapy or surgery and thereby help extend the time until hormonal therapy is needed," Pruthi said.

"This clinical trial will better evaluate the clinical potential of Cox-2 as an anti-tumor medication in prostate cancer," he added. "We're interested in determining if this group of medications work for patients who otherwise are told 'Your cancer has come back but we have no appropriate treatment options for you at this stage.' "

Up to 100 patients will be studied in this UNC investigation. Support for the research comes from the Lineberger Center.

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