Influence of Regular Statin Intake on Prostate-Specific Antigen Values, Prostate Cancer Incidence and Overall Survival in a Prospective Screening Trial (ERSPC Aarau).

Objective: While statins have demonstrated a variety of antineoplastic effects in preclinical studies, several retrospective clinical studies and observational studies have not shown a consistent chemopreventive benefit against prostate cancer (PCa). Therefore, in this population-based cohort study, we examined the association of statin intake on prostate specific antigen (PSA) values and risk of development of PCa.

Method: N = 4,314 men from the Swiss section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) were evaluated. N = 761 men were statin users [Stat+]. The median follow-up was 9.6 years. A transrectal prostate biopsy was performed in men with a PSA-level ≥ 3 ng/mL. Mortality and incidence data was obtained through registry linkages. PCa incidence, total serum PSA level, free-to-total PSA level, and overall survival were compared between [Stat+] and [Stat-] patients.

Results: Total PSA values were significantly lower in [Stat+] patients at baseline (1.5 vs. 1.8 ng/mL, p < 0.001) and at last follow-up (1.8 vs. 2.1 ng/mL, p < 0.001). PCa detection during the follow-up period was significantly associated with baseline PSA. The overall incidence of PCa showed no statistical difference among [Stat+] and [Stat-] groups (7.4% vs. 9.5%, p = 0.08), indicating that statin use had no effect on the risk of developing PCa during follow-up. [Stat+] patients had a significantly higher overall mortality risk compared to [Stat-] patients (HR 2.04, p < 0.001).

Discussion: A significant risk reduction in the development of PCa in [Stat+] patients was not found. We did observe lower PSA values among [Stat+] patients, compared to [Stat-] patients, with an increasing difference during follow-up.