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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A new oral medication called ARAMIS is being evaluated in men who have rising PSA levels on Lupron and whose bone scans remain clear. For more information, visit: https://clinicaltrials.gov/show/NCT02200614
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.
Cancer that spreads outside the prostate gland is what makes prostate cancer dangerous. Metastatic prostate cancer cells cause malfunction by impeding normal function. Some organs, like lymph nodes for example, continue to function quite nicely, even if the degree of cancer spread is extensive. Lymph node spread, therefore, is the least dangerous form of prostate cancer metastases. At the other end of the spectrum is the liver, which is far less tolerant. The seriousness of bone metastases, the most common site of prostate cancer spread, lies about half way between that of node metastases and liver metastases.
Every day in the office, as a practicing prostate oncologist, I confront serious problems: PSA levels that are rising, treatments causing too many side effects, patients desperately worried about their future. And sometimes, given our limited tools, the solutions we can offer are only partial. However, every time the FDA approves a new treatment there is an excitement akin to opening gifts on Christmas morning. All of a sudden we have a shiny new tool in the tool chest to help us do a better job.
I have never seen a real game of chicken where two cars race head on toward each other to see who will swerve first, i.e., who is chicken. However, we are seeing an actual game of chicken being played out before our eyes on the national stage.
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.