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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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