WEDNESDAY, Aug. 15 (HealthDay News) -- A new investigational drug known as enzalutamide adds an average of five months to the lives of men with advanced prostate cancer, a new study has found.
This is such a significant finding that the trial was stopped early so men receiving a placebo could opt to take enzalutamide.
"We found a hormonal drug prolongs the lives of men who have failed traditional hormones as well as chemotherapy," said lead researcher Dr. Howard Scher, chief of the genitourinary oncology service at Memorial Sloan-Kettering Cancer Center in New York City.
In addition, these results show that even after failing regular hormone therapy these tumors can still react to a hormone-based treatment, he said.
Scher said he believes enzalutamide might be even more effective if used in men with earlier stages of prostate cancer. Trials testing that theory are under way, he said.
One of the reasons for testing the drug in late-stage cancer is to speed U.S. Food and Drug Administration approval, Scher said.
The results of the study were published online Aug. 15 in the New England Journal of Medicine.
In this phase 3 trial, nearly 1,200 men with advanced prostate cancer were randomly selected to take either enzalutamide, which is taken orally, or a placebo. The men had already undergone chemotherapy, the researchers noted.
Compared to those on placebo, men taking enzalutamide lived an average of nearly five months longer and their risk of dying was reduced by 37 percent, the researchers found.
The drug is not without side effects, however, the most serious of which were seizures.
"[Seizures] occurred in five of the 800 patients who received the drug," Scher said. Many of these patients had factors making them susceptible to seizures, he said.
Enzalutamide patients also reported hot flashes, fatigue and diarrhea.<
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