And it extends life for men with advanced disease, researchers say
MONDAY, May 31 (HealthDay News)-- The newly approved therapeutic prostate cancer vaccine, Provenge, is safe and has few side effects, a new study finds.
In April, the U.S. Food and Drug Administration approved the vaccine for use in men with advanced prostate cancer who had failed hormone therapy.
"Provenge was approved based on both safety and clinical data," said lead researcher Dr. Simon J. Hall, chair of urology at Mount Sinai Medical Center in New York City.
This safety data shows that there are very limited side effects, Hall added.
The advantage of the vaccine for patients with metastatic hormone-resistant prostate cancer is that it has fewer side effects than chemotherapy, which is the only other treatment option for these patients, Hall explained.
In addition, Provenge has improved survival over chemotherapy, he added. The average survival time for men given Provenge is 4.5 months, although some patients saw their lives extended by two to three years.
"This is a newly available treatment, with very limited side effects, compared to anything else that a man would be considering in this state," Hall said.
Hall was to present the results on Monday at the American Urological Association annual meeting in San Francisco.
Data from four phase 3 trials, which included 904 men randomized to either Provenge or placebo, showed the vaccine extended survival, improved quality of life and had only mild side effects.
In fact, more than 83 percent of the men who received Provenge were able to do perform activities without any restrictions, the researchers noted.
In terms of side effects, the most common were flu-like symptoms such as chills, fever and headache, which were seen in 3.5 percent of the men. Usually it took only a day or two for the symptoms to resolve.
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