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.
One of the unique characteristics of prostate cancer is its responsiveness to the withdrawal of testosterone. This “Achilles Heel” of prostate cancer was discovered in the 1940’s when surgical removal of the testicles was shown to induce cancer remissions. In 1985, Lupron, an injectable medication that works by tricking the testicles into ceasing testosterone production, was FDA approved. Orchiectomy, or surgical removal of the testicles, has been declining in popularity ever since.