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