Radium-223 Dichloride, otherwise known as Xofigo, is the first alpha-emitting radiopharmaceutical used to treat prostate-cancer-related bone metastasis. The FDA approved Xofigo in May of 2013. The clinical trial that led to the FDA approval was called the ALSYMPCA trial. Eligible patients were randomized in a 2:1 fashion to either receive six monthly intravenous injections of radium-223 or best standard of care, such as antiandrogen hormonal therapy, local external beam radiation, corticosteroids, estramustine, or ketoconazole. The men who received radium-223 had improvement in bone pain and also experienced an increased survival.
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Radium-223 is used to treat bone metastases, a common problem for men living with metastatic hormone resistant prostate cancer (MHRPC), affecting up to 90% of these patients. The development of a drug called radium-223 (brand name: Xofigo) is a substantial innovation, not only because it causes less toxicity compared to its predecessors, but also because it prolongs life.
In May 2011, the New England Journal of Medicine reported on 695 men from Sweden, Finland, and Iceland, average age 65, who were randomly allocated to either immediate surgery or delayed hormone therapy (DHT) between 1989 and 1999. The median PSA for the 695 men was 13. Eighty percent of the men had palpable disease found during their digital rectal exam. In the men treated with DHT, hormone therapy was initiated if and when bone metastasis occurred. Bone scans were performed every other year.