Evaluation of a low-invasive strategy for prostate cancer screening with prostate-specific antigen

Objectives. To evaluate a two-step strategy for the detection of prostate cancer within the context of serial screening and compare this strategy with other screening strategies. The optimal combination of tests proposed for prostate cancer screening remains undetermined, particularly when screening is repeated over time. Methods. A prospective serial prostate cancer screening study with follow-up to 55 months was performed in a general community screening clinic. One thousand seven hundred seven self-referred men, 50 to 75 years old, without a history of prostate cancer agreed to undergo screening for prostate cancer on an annual basis. Serum prostate-specific antigen (PSA) measurement was the first-step screening test. If the serum PSA test was positive, a standard urologic evaluation was performed. Biopsy was recommended only if a test other than serum PSA was suspicious for cancer. The outcome measures were the biopsy rate and prostate cancer detection rate. The comparisons with other studies were age-standardized to correct for differences in age distribution. Results. The biopsy and cancer detection rates after the first test were 7.0% and 2.0%, respectively. After 4 years of the study, the cumulative biopsy rate and cumulative cancer detection rate per enrolled man was 12% and 4.1%, respectively. The comparisons between studies revealed that screening strategies using serum PSA as a first-line test had similar detection rates but lower biopsy rates than strategies performing biopsy when one of several screening tests was positive. Conclusions. A two-step screening strategy using serum PSA alone as the initial test seemed able to detect as many cancers as when all screening tests were used at the same time but reduced the number of unnecessary biopsies.