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Therapeutics
Finasteride reduced prostate cancer but led to more high grade tumours and sexual side effects

https://doi.org/10.1136/ebm.8.6.183

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    (2003) N Engl J Med 349, 215. Thompson IM, Goodman PJ, Tangen CM, et al.. The influence of finasteride on the development of prostate cancer.. ;. :. –24.
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 QUESTION: In healthy men, does finasteride prevent prostate cancer?

    Design

    Randomised {allocation concealed*}†, blinded {participants, healthcare providers, data collectors, outcome assessors, and data analysts}†,* controlled trial with ≥7 years of follow up.

    Setting

    USA.

    Patients

    16 295 men who were ≥55 years of age, had a normal digital rectal examination and an American Urological Association symptom score <20, and did not have clinically significant coexisting conditions. 61% of men either had a biopsy at the end of the study or their prostate cancer status was known.

    Intervention

    Men were allocated to finasteride, 5 mg/day (n=8137), or placebo (n=8158).

    Main outcome measures

    Prostate cancer rate and adverse events.

    Main results

    Analysis was by intention to treat. …

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    Footnotes

    • Source of funding: National Cancer Institute.

    • For correspondence: Dr I M Thompson, Southwest Oncology Group, San Antonio, TX, USA. thompsoni{at}uthscsa.edu

    • ↵* See glossary.

    • ↵† Information provided by author.

    • ↵‡ p Value calculated from data in article.