📃 Paper Title: Effect of Dutasteride on the Risk of Prostate Cancer (The REDUCE study)
🧍 Author: Andriole
🕒 Year: 2010
📚 Journal: The New England Journal of Medicine (NEJM)
🌎 Country: USA
ㅤContext to the study:
Whcih study compared the use of dutasteride to placebo in patients considered at increased risk of prostate cancer?
ㅤ✅ Take-home message of study:
In a randomised controlled trial of approximately 7,000 patients considered at increased risk of prostate cancer, the use of dutasteride at 0.5mg once daily led to a relative risk reduction in prostate cancer of 22.8% at 4 years compared to placebo. The incidence of prostate cancer was 19.9% in the dutasteride group and 25.1% in the placebo group (i.e. absolute risk reduction: 5.1%) at 4 years. No significant differences were seen between groups in the incidence of Gleason 7 to 10 disease.
ㅤ Multi-centre, randomised controlled trial (Double-blinded)
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Study participants:
Total included: n= 6,729
Dutasteride (0.5mg daily): n= 3,305
Placebo group: n= 3,424
Inclusion criteria:
Men considered at increased risk of disease, as defined by:
Aged 50 to 75 years and
PSA 2.5 to 10.0 ng/mL and
Undergone single prostate biopsy within 6 months before enrollment with a negative result for prostate cancer
Exclusion criteria:
Men who had undergone > 1 biopsy
Known prostate cancer or previous history of prostate cancer
High-grade intraepithelial neoplasia or atypical small acinar proliferation
Prostate volume > 80 mL
Previous prostate surgery
IPSS score of 25, or 20 in men taking blockers
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Key study outcomes:
Enrolled patients underwent prostate biopsy (10 cores) at 2 and 4 years:
Primary outcome: incidence of prostate cancer on biopsy at 4 year follow-up
Dutasteride group: 19.9%
Placebo group: 25.1%
Dutasteride led to a relative risk reduction of prostate cancer of 22.8%
Selected secondary outcomes:
Incidence of Gleason 7-10 disease at 4 year follow-up::
Dutasteride group: 6.7%
Placebo group: 6.8%
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Study Limitations:
Involvement of the pharmaceutical industry in the design of this study
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