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Controversy exists regarding prostate cancer (PC) screening using the prostate-specific antigen (PSA) test. It may reduce PC mortality risk but is associated with false-positive results. We aimed to evaluate the incidence of false-positive and false-negative results in a general clinical setting and the associated variables. We found a high rate of false-positive results (46.6%), resulting in a positive predictive value of 12.7%. Patients also showed a low rate of false-negative results (3.7%) with a negative predictive value of 99.5%. Age, alcohol intake, and having a urinary tract infection were associated with a higher probability of false-positive results; having diabetes mellitus type II was associated with a lower rate of false-positive results. This study showed a higher rate of false-positive results in clinical practice than in previous clinical trials, mainly in patients over 60 years.

(1) Background: There are no real-world data evaluating the incidence of false-positive results. We analyzed the clinical and analytical factors associated with the presence of false-positive results in PSA determinations in practice. (2) Methods: A prospective cohort study of patients with a PSA test was performed in clinical practice. We followed the patients by reviewing their medical records for 2 years or until the diagnosis of PCa was reached, whichever came first. (3) Results: False-positive PSA rate was 46.8% (95% CI 44.2–49.2%) and false-negative PSA rate was 2.8% (95% CI 2–3.5%). Patients aged 61–70 years and those over 70 years were more likely to have a false-positive result than those under 45 years (aOR 2 …