Does Dutasteride (Avodart) Increase Prostate Cancer Risk?


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Results of a four-year study show that men who took dutasteride (Avodart), a drug commonly prescribed for benign prostatic hyperplasia (BPH), were less likely to be diagnosed with prostate cancer. However, men taking dutasteride who did develop prostate cancer were more likely to have more deadly tumors—those with a high Gleason score—than men who took a placebo. The study appears in The New England Journal of Medicine (April 2010).

All of the 6,729 men enrolled in the study were at high risk for prostate cancer but believed to be disease-free when the study began. Prostate biopsies were done at two and four years. Although 25 percent of men who took placebo developed prostate cancer compared with 20 percent of those who took Avodart, investigators are unsure whether dutasteride helped prevent the development of cancer or whether it suppressed PSA levels.

Men who are taking Avodart and who undergo PSA screening should inform their healthcare provider they are taking the drug and about the results of this study.

In a follow-up to this study (March 2011), the makers of Avodart (GlaxoSmithKline) decided to stop seeking approval for dutasteride for treatment of prostate cancer. The pharmaceutical company had hoped to market the drug as an option for reducing the risk for prostate cancer in men at high risk. GlaxoSmithKline made this decision after experts kept debating whether use of the drug contributed to the development of more aggressive prostate cancer as seen in the study or whether it allowed clinicians to detect it earlier.

Read more in our Prostate Cancer Health Center.

References

Andriole GL et al. Effect of dutasteride on the risk of prostate cancer. New England Journal of Medicine 2010 Apr 1; 362(13): 1192-202

Maugh TH. Company will no longer seek approval for dutasteride (Avodart) to prevent prostate cancer. LA Times 2011 Mar 24