WebMD Medical News
Laura J. Martin, MD
Jan. 23, 2012 -- A drug widely prescribed to treat men with enlarged prostates may also slow the growth of early prostate cancers, according to a new study.
Researchers say the drug Avodart (dutasteride) may reduce the need for aggressive treatments in men who have a very low risk of dying from their disease.
But there are also concerns that the drug and others in the same class may have no effect on more deadly cancers or may actually fuel their growth, leading several experts to conclude that more study is needed before they can be recommended as a treatment of prostate cancer.
“These drugs are not without side effects,” says Durado Brooks, MD, MPH, who is director of prostate and colorectal cancers for the American Cancer Society. “They do seem to decrease the growth of low-grade cancers, but questions remain about whether they have much activity against high-grade disease.”
As many as 1 in 5 men in the United States will be diagnosed with prostate cancer at some time in their lives, but most have low-risk cancers that will never cause them harm.
Withholding treatment while closely monitoring the cancer, known as watchful waiting or active surveillance, is increasingly recommended as an alternative to surgery or radiation for men with low-risk cancers.
The strategy is now common in many parts of the world, but most American men still opt for active treatment.
“Nine out of 10 men with low-risk disease in the U.S. are still getting treatment, either because they aren’t offered active surveillance or because they rejected it,” Brooks says. “Americans are action oriented, and the idea of not treating a known cancer goes against the U.S. psyche.”
Since surgery and radiation involve a risk of life-altering side effects, including erectile dysfunction and incontinence, different treatment approaches are needed for men with low-risk disease, says Neil E. Fleshner, MD, MPH, of Toronto’s Princess Margaret Hospital.
Fleshner and colleagues recruited slightly more than 300 men with low-risk prostate cancers to assess the impact of Avodart on cancer progression.
Roughly half the men in the study took the prostate drug for three years while the other half took placebo pills.
Biopsies were performed after 18 months and three years to measure disease progression, and the men completed questionnaires about how anxious they were about their cancer.
Men treated with Avodart reported significantly less cancer-related anxiety.
They were also more likely to have delayed prostate cancer progression and show no evidence of cancer on their final biopsy.
The Avodart-treated patients did experience more drug-related side effects (24% vs. 15%), consisting mainly of sexual dysfunction.
The study was funded by Avodart manufacturer GlaxoSmithKline, and the company was also involved in its design, Fleshner says.
It appears this week in the online edition of the journal The Lancet.
Fleshner says the fact that significantly fewer men who took Avodart chose to have surgery or radiation shows a "real world" benefit for the treatment.
But Brooks says the study was not large enough or the follow-up long enough to prove that the drug improves long-term outcomes in patients with low-risk prostate cancers.
He agrees that drug treatments that clearly affect disease progression could convince more low-risk patients to forgo surgery or radiation.
“Unfortunately, I don’t think we can put this drug in that category yet,” he tells WebMD.
“With or without a drug treatment, we now know that active surveillance is a reasonable approach for many men with low-risk prostate cancers,” Brooks says.
“We now have relatively well-defined criteria to tell us when active surveillance is appropriate and reasonable protocols to help us follow men who choose this path.”
SOURCES:Fleshner, N. Lancet, published online Jan. 24, 2012.Neil E. Fleshner, MD, MPH, head of the division of urology, University Health Network, Toronto; professor of surgery, University of Toronto, Canada.Durado Brooks, MD, MPH, director of prostate and colorectal cancers, American Cancer Society.News release, Lancet.
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