[Skip to Content]
[Skip to Content Landing]
October 1, 2003

Reliability and Validity of Prostate-Specific Antigen

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2003;290(13):1705-1706. doi:10.1001/jama.290.13.1705-a

In Reply: We agree with Drs Hakama and Auvinen that our data are not ideally suited to a definitive study of the validity of the PSA test because no biopsies were performed and patients were not specifically evaluated for the development of prostate cancer over time. Nonetheless, our study provided an unusual opportunity to observe natural variations in levels of PSA over time, which were largely unaffected by clinical interventions. Our results do not address the validity of the PSA test, but strongly suggest that the amount of circulating PSA varies markedly over time in an individual patient. This variability challenges the recommendation for further invasive testing, including prostate biopsy, solely on the basis of a single PSA result. The fluctuations in PSA levels we observed are not related to "laboratory problems," as suggested by Hakama and Auvinen. As we detailed in our article, all PSA tests were performed in a research laboratory on properly stored and prepared samples. We focused our attention on the frequency with which elevated levels of PSA returned to the normal range, because men with such fluctuating levels are at greatest risk of unnecessary biopsy.