Results from a recent clinical trial indicate that denosumab delayed the spread of prostate cancer metastases bones, however it did not prolong the lives of men.
Despite these findings, Dr. Matthew R. Smith, the lead investigator in the trial and a consultant to Amgen, said the results were meaningful because no drug before had been proved to prevent the spread of bone metastases (mets) in prostate cancer. This is significant because bone is a major cause of pain and disability in men with prostate cancer.
“This study is the first to demonstrate prevention of bone metastasis, the most devastating complication of prostate cancer,” Dr. Smith, an associate professor at Harvard Medical School and the Massachusetts General Hospital, said in an e-mail. “It addresses a critical unmet need.”
The trial involved 1,432 men with castrate resistant prostate cancer and without bone mets. The men were randomly assigned to receive denosumab every four weeks or a placebo. All subjects were considered to be a high risk for developing bone mets.
The goal was to see determine if denosumab could delay the time until either the cancer spread to the bone or the patient di