One the Horizon – A new clinical trial of Alpharadin – Injectable Radium-223
ByDr. Oliver Sartor of Tulane Cancer Center is recruiting men with hormone resistant prostate cancer (HRPC) and bone metastases for a new phase III clinical trial to test the effectiveness of a drug that targets prostate cancer that has spread to bones. Tulane is the first site in the United States to participate in this large international multi-center clinical trial that is currently recruiting patients at 100 sites in 20 countries worldwide.
The trial will compare men treated with the investigational drug, Alpharadin (Al-fa-RAY-din), which is an injectable alpha-particle emitting pharmaceutical based on the radioactive substance Radium-223.
“Alpharadin appears to work by targeting and destroying cancer cells in the bone while sparing healthy bone marrow tissue,” said Sartor, who is the Piltz Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine. “If successful in clinical trials, this compound could make a significant difference for the large number of men whose cancer has spread to the bones. Patients most often die as a consequence of the metastases – not the primary cancer – so preventing cancer from spreading and controlling cancer that has spread is a major clinical challenge.”
The investigational drug, along with standard therapy, will be given to two-thirds of the subjects with the other third of the participants receiving a placebo along with the standard of care therapy.
The early phase I AND ii trials of Alpharadin have suggested that its side effects are manageable and that the drug might prolong survival for men whose prostate cancer is no longer responding to hormone therapy and has spread to the bones.
We all know that the treatment options for men with metastatic prostate cancer of the bones are limited, and our life expectancy, if left untreated, averages only 12 to 18 months. Bone metastases are very debilitating and painful. As the metastasis grows the bone pain becomes very severe, coupled with other serious complications including neurological symptoms, fractures, severe anemia, or spinal cord compression, our quality of life decreases significantly along with our life expectancy.
Physicians and patients interested in learning more about this phase III clinical trial can contact the Tulane Cancer Center at 504-988-7869 or go to www.clinicaltrials.gov and search for Alpharadin.
Joel T Nowak MA, MSW
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