Prospective cohort studies support that statin drug users have a lower risk of aggressive prostate cancer. Whether statin drug use influences risk of screen-detected disease is less clear, possibly because of complex detection biases. Thus, we investigated this association in a setting in which men had low baseline serum PSA concentration and were screened annually.

We conducted a cohort study of 9,457 men aged ≥55 years old at randomization to the placebo arm of the Prostate Cancer Prevention Trial. The men reported new use of medications quarterly. We estimated the multivariable-adjusted hazard ratio (HR) of prostate cancer (N=574 in 62,192 person-years) for use of a statin drug and duration of use during the trial using Cox proportional hazards regression.

Over seven years of follow up, use of a statin drug during the trial was not associated with risk of total (HR=1.03, 95% CI 0.82-1.30), lower- (HR=0.96, 95% CI 0.71-1.29), or higher-grade (HR=1.27, 95% CI 0.85-1.90) prostate cancer. Duration of use during follow-up also was not associated with risk of total (P-trend=0.7), lower- (P-trend=0.5), or higher- (P-trend=0.2) grade disease.

These prospective results do not support the hypothesis that statin drugs protect against prostate cancer in the setting of regular prostate cancer screening.