"Based on the study results, this drug could fill an important gap in prostate cancer treatment today. The strong response to this new use of enzalutamide shows that it can provide a viable, less toxic alternative to chemotherapy in staving off the disease in men who aren't responding to standard first line hormonal treatments," said
The double blind Phase III study included 1,717 research participants enrolled at 207 sites globally between
The trial, named PREVAIL, was concluded early, after a planned interim analysis, because of overwhelming response to the treatment. At this point, 72 percent of enzalutamide patients and 63 percent of placebo patients were alive at the trial cutoff date showing a 29 percent overall improvement in survival. Fatigue and hypertension were among the most common clinically relevant side effects.
Prostate cancer is the most common form of cancer in men and the second leading cause of cancer-related death in the US and the sixth leading cause of cancer-related death among men worldwide. Hormone therapies are used to treat prostate cancer patients whose disease either isn't responding to radiation or surgery or has already spread beyond the prostate gland. Male hormones, called androgens, cause prostate cancer cells to grow. Hormone therapies, known as androgen deprivation therapies, help arrest the disease by reducing a patient's androgen levels. Enzalutamide works differently than other hormone therapies; rather than reducing hormone levels, it blocks hormone binding to the androgen receptor - an essential step in hormone action.
"In the past few years we have vastly expanded treatment options for prostate cancer," Beer said. "We are working hard to provide answers and options for men whose disease still resists treatment. The results of this clinical trial are extremely gratifying because they represent a leap forward for those patients."
Beer's team of prostate cancer researchers at
Enzalutamide, which is taken as four pills once per day, is already approved by the
Along with Beer and the
During the study, Beer had grants from Astellas Pharma Global and
Keywords for this news article include: Drugs, Cancer, Surgery, Hormones, Hospital, Oncology,
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC
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