Abstract

To quantify the effect of statins’ use on Prostate Specific Antigen (PSA) levels in patients referred to prostate biopsy and to determinate if the exposure to statins must be considered to improve the prostate cancer diagnostic accuracy of PSA. We selected 551 subjects with PSA <10.0 ng/mL, referred to ultrasound guided trans-rectal prostate biopsy and classified as cancer or non-cancer patients after biopsy. Information regarding statins’ use was obtained from clinical records. We used path analysis to quantify the direct (reflects the influence on PSA biology and metabolism) indirect (reflects the influence on PSA through the effect on the risk of prostate cancer) and total effects (net result of direct and indirect effects) of statins’ use on PSA. We used Receiver Operating Characteristic curves to assess the global predictive accuracy of models including PSA, age, body mass index, 5-α-reductase inhibitors, aspirin and statins’ use for distinguishing between prostate cancer and benign conditions. We observed a negative total effect of statins on PSA levels (users vs. non-users: −0.633 ng/mL, 95% CI: −1.087, −0.179), which corresponds to approximately 8.9% lower levels among statins’ users, mostly due to the direct effect (−0.588 ng/mL, 95% CI: −1.034, −0.141) rather than that by the indirect effect (−0.045 ng/mL, 95% CI: −0.152, 0.061). There were no statistically significant differences between the area under the curve corresponding to the models with or without statins (P = 0.274). In patients referred to prostate biopsy, statins’ use contributed to lower Prostate Specific Antigen levels, but the clinical impact in these patients is low.