The trial’s primary endpoint was overall survival.
Radium prostate cancer trial#
Men in the trial were randomly assigned to receive either radium-223 (six intravenous injections, one every 4 weeks) plus the best standard of care or a placebo plus the best standard of care. The Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial enrolled 921 patients with metastatic, castration-resistant prostate cancer. Once the drug, which can be given intravenously, reaches bone, it emits very low levels of radiation that travel less than 100 microns, or approximately four one-thousandths of an inch, limiting damage to the surrounding tissues. Radium-223 is a “calcium mimetic” that, like calcium, accumulates preferentially in areas of bone that are undergoing increased turnover, such as areas where bone metastases are forming. The alpha particle radiation causes double-strand breaks in DNA, killing cells. Radium-223 dichloride (radium-223) is a radioactive isotope that emits low levels of alpha particle radiation. Several drugs have been approved by the Food and Drug Administration (FDA) to prevent pain and fractures in patients with bone metastases, but none of these drugs improves the survival of men with prostate cancer. Bone metastases can cause intense pain, weakness, and bone fractures, greatly impairing quality of life-and in some cases causing death. In most men with metastatic castration-resistant prostate cancer-prostate cancer that no longer responds to hormone therapy-the cancer spreads (metastasizes) to the bones. New England Journal of Medicine ( NEJM), J(See the journal article.) Background Results from a phase III trial called ALSYMPCA show that radium-223 dichloride (Xofigo®) improves overall survival in men with advanced prostate cancer that has spread to their bones compared with a placebo.
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