The drug dutasteride delays both cancer progression and the start of active treatment for men diagnosed with low-risk, localized prostate cancer, according to results from a 3-year international clinical trial led by Dr Neil Fleshner, Head of the Division of Urology, University Health Network (UHN). The findings are published online in The Lancet.
“The results prove that using active surveillance plus dutasteride is a viable, safe and effective treatment option for men who often undergo aggressive local treatment despite low risk of dying from the disease,” says Dr Fleshner, a surgical oncologist in UHN’s Princess Margaret Cancer Program and professor of surgery at the University of Toronto.
Dr Fleshner goes on to say, “This is very good news for men with low-risk disease because aggressive treatment can have a major impact on their quality of life, with risks of impotence and incontinence.”
The clinical trial, known as REDEEM (REduction by Dutasteride of clinical progression Events in Expectant Management of prostate cancer), included 302 men between the ages of 48 and 82. The men were diagnosed with low-risk localized prostate cancer and were under active surveillance. During the trial, participants received either dutasteride or a matching placebo daily. At 1.5 and 3 years, the men underwent biopsies.
For the men treated with dutasteride, the study showed a significant reduction in disease progression: 38% progressed, compared with 48% of those who took the placebo. Furthermore, the 3-year biopsies showed a lower incidence of tumor detection among patients treated with dutasteride: 36% had no cancer detected, compared with 23% among those who received the placebo.
“This is the first study to show that a 5a-reductase inhibitor such as dutasteride reduces the need for aggressive treatment in low-risk disease,” says Dr Fleshner. “The drug, currently commonly used to treat enlarged prostate, works by inhibiting the male sex hormone that causes the enlargement in the first place.”
Source: University Health Network.