Pilot study of the practical relevance of a one-step test for prostate-specific antigen in capillary blood to improve the acceptance rate in the early detection program of prostate carcinoma

Abstract

Objective: Current studies have proven that early,organ-confined stages of prostate cancer can be diagnosed through screening based on PSA levels, thus reducing cancer mortality. Here we report about our experience using an innovative one-step test for PSA in capillary blood. Methods: The incubation time for a 50 μl blood sample with the indicator strip is 12 minutes until the qualitative visual results (<4.0 ng/ml or ≥ 4 ng/ml)appear. In cooperation with urologists and accompanied by an extensive information campaign, the one-step test was made available free of charge to all men between the ages of 45 and 75 in all 28 pharmacies of our city (100,000 inhabitants). Results: The test's acceptance rate among the 2119 participants between the ages of 45 and 75 years amounted to 13.0%. Fifteen percent of all the tests conducted showed a positive PSA result (≥ 4 ng/ml). Prostate carcinoma was histologically confirmed in 14 (0.66%) of the men, nine times in the early stage (T2) and five times in the clinical stage (T3),corresponding to an incidence of circa 650 cases per 100,000 men in the target age group. Conclusions: This newly developed PSA test system can enhance the acceptance rate and effectiveness of medical check-ups for prostate cancer, because it is easy-to-use, cost-effective and accurate (specificity 81.3%, sensitivity 91.1%). The test should be always conducted by an experienced physician. It is not a substitute for a regular physical examination (DRE, TRUS, biopsy...).