Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial

✍ Scribed by Neil E Fleshner; M Scott Lucia; Blair Egerdie; Lorne Aaron; Gregg Eure; Indrani Nandy; Libby Black; Roger S Rittmaster

• Book ID: 117309388
• Publisher: The Lancet
• Year: 2012
• Tongue: English
• Weight: 217 KB
• Volume: 379
• Category: Article
• ISSN: 0140-6736
• DOI: 10.1016/s0140-6736(11)61619-x

✦ Synopsis

Background We aimed to investigate the safety and effi cacy of dutasteride, a 5α-reductase inhibitor, on prostate cancer progression in men with low-risk disease who chose to be followed up with active surveillance.

Methods In our 3 year, randomised, double-blind, placebo-controlled study, undertaken at 65 academic medical centres or outpatient clinics in North America, we enrolled men aged 48-82 years who had low-volume, Gleason score 5-6 prostate cancer and had chosen to be followed up with active surveillance. We randomly allocated participants in a one-to-one ratio, stratifi ed by site and in block sizes of four, to receive once-daily dutasteride 0•5 mg or matching placebo. Participants were followed up for 3 years, with 12-core prostate biopsy samples obtained after 18 months and 3 years. The primary endpoint was time to prostate cancer progression, defi ned as the number of days between the start of study treatment and the earlier of either pathological progression (in patients with ≥1 biopsy assessment after baseline) or therapeutic progression (start of medical therapy). This trial is registered with ClinicalTrials.gov, number NCT00363311.