Dutasteride was linked to lower prostate cancer progression rates than placebo in a cohort of men with low-risk disease, according to study findings.
The aim of the 3-year, randomized, double blind, placebo-controlled REDEEM study was to investigate the safety and efficacy of dutasteride (Avodart, GlaxoSmithKline) on prostate cancer progression in 302 men. The patient population was aged 48 to 82 years, had low-risk disease (Gleason score of 5-6) and chose to be followed up with active surveillance.
The study was conducted at 65 academic medical centers or outpatient clinics in North America from Aug. 10, 2006, to March 26, 2007.
Participants were randomly assigned once-daily dutasteride 0.5 mg or matching placebo in a 1:1 ratio. Twelve-core prostate biopsy samples were taken after 18 months and 3 years of treatment.
The primary outcome measure was time to prostate cancer progression, which the researchers defined as the number of days between the initiation of study treatment and the earlier of one of two progression points: pathological progression (in patients with at least one biopsy assessment after baseline) or therapeutic progression (start of medical therapy).
The primary analysis included 289 men who had at least one biopsy procedure after baseline.
Three-year results indicated that 38% of 144 men in the dutasteride arm and 48% of 145 men in the control arm had prostate cancer progression. The HR for pathological or therapeutic progression was 0.62 (95% CI, 0.43-0.89).
Adverse event profiles were similar between the groups. Sexual adverse events or breast enlargement or tenderness occurred in 24% of men assigned the study drug and 15% of men assigned placebo.
Cardiovascular adverse events were observed in 5% of men in the dutasteride arm and 5% of controls. The researchers did not observe any prostate cancer-related deaths or instances of metastatic disease.
“Dutasteride could provide a beneficial adjunct to active surveillance for men with low-risk prostate cancer,” they wrote.