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No "Normal" PSA Level, Study Finds

July 6, 2005
How accurate is the popular PSA test in detecting prostate cancer? There's no simple answer to the question.

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A study in the latest issue of The Journal of the American Medical Association (JAMA) finds there is no specific PSA value that indicates the presence of prostate cancer, but rather there is a continuum of prostate cancer risk at all values of PSA.

Measurement of prostate-specific antigen (PSA) levels for the early detection of prostate cancer is one of the most common cancer screening activities in the United States.

In 2001, approximately 75 percent of men in the United States aged 50 and older reported that they had previously undergone PSA screening and 54 percent have reported regular PSA screening.

In general, prostate biopsy has not been recommended unless PSA levels exceed a threshold value, generally 4.0 ng/mL, with slightly lower values recommended recently by some researchers. Prostate cancer screening with PSA has been controversial, as no studies have proven that this strategy reduces death from prostate cancer.

Ian M. Thompson, M.D., of the University of Texas Health Science Center at San Antonio, and colleagues conducted a study to determine the effectiveness of PSA testing by estimating the receiver operating characteristic (ROC) curve (a measure of diagnostic accuracy) for PSA.

They found that for detecting any prostate cancer, PSA cutoff values of 1.1, 2.1, 3.1, and 4.1 ng/mL yielded sensitivities of 83.4 percent, 52.6 percent, 32.2 percent, and 20.5 percent, and specificities of 38.9 percent, 72.5 percent, 86.7 percent, and 93.8 percent, respectively.

"… a clear-cut decision rule for prostate biopsy based on PSA values would be challenging to derive from these data,” that “… there is no single cutoff that would simultaneously yield both high sensitivity and high specificity," the authors write.

Currently, men in the United States have a 17.3 percent lifetime risk of prostate cancer diagnosis, while the lifetime risk of prostate cancer death is 3 percent.

"The implications of this analysis are substantial,” the authors conclude. “ It will be a challenge to the medical community to change the long-held notion that there is a 'normal' PSA level. Patients and health care professionals must be re-educated that there is a continuum of risk and no clearly defined PSA cutpoint at which to recommend biopsy.”

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