Abstract

Background

Clinical trial results suggested that prostate-specific antigen (PSA) screening can reduce prostate cancer mortality. Nevertheless, because the specificity of the PSA test for cancer detection is low, it leads to many negative biopsies. The Beckman Coulter Prostate Health Index (PHI) testing demonstrates improved specificity compared with the PSA-only screening and therefore may improve the cost-effectiveness of prostate cancer detection.

Objective

To examine the cost-effectiveness of adding PHI testing to improve cancer detection for men with elevated serum PSA.

Methods

A microsimulation model, based on the results of the European Randomized Study of Screening for Prostate Cancer trial, was used to evaluate the effects of PSA screening and PHI reflex testing. We predicted the numbers of prostate cancers, negative biopsies, deaths, quality-adjusted life-years gained, and cost-effectiveness of both PSA (cutoff 3 ng/mL) and PHI (cutoff 25) testing methods for a European population, screened from age 50 to 75 years at 4-year intervals.

Results

When the PHI test was added to the PSA screening, for men with a PSA between 3 and 10 ng/mL, the model predicted a 23% reduction in negative biopsies. This would lead to a 17% reduction in costs for diagnostics and 1% reduction in total costs for prostate cancer. The cost-effectiveness (3.5% discounted) was 11% better. Limitations found were the modeling assumptions on the sensitivity and specificity of PHI by tumor stage and cutoff values.

Conclusions

Compared with PSA-only screening, the use of a PHI test can substantially reduce the number of negative biopsies and improve the cost-effectiveness of prostate cancer detection.