Screening for prostate cancer: Controversy? What controversy?

for the absence of a reduction in mortality in the plco trial and in comparison with the difference seen in the erspc trial. The truth of the matter is the psa test should not be used at all in screening for prostate cancer in the manner it has heretofore been used. Prostate-specific antigen, discovered in 1970 5,6 , is a normal component of the prostate. It is not cancer-specific. Rather, it is present in the normal, benign, and malignant prostate 7. When the U.S. Food and Drug Administration (fda) approved the psa test in 1994 for screening, the approval was not based on rigorous study of the specificity or sensitivity of the test. The fda never looked at the benefits and risks beyond a 3.8% detection rate compared with a 0.8%–1.4% detection rate for dre. The ability of the psa test to identify men with prostate cancer is slightly better than that of flipping a coin. Further, prostate cancer is an age-related disease , and the psa test may merely precipitate a biopsy, wherein, related to age, the biopsied individual may or may not have cancer—a finding that, according to some, may be related to " how hard it (i.e., cancer) is looked for " 8. With approximately 45%–80% of men between the ages of 50 and 75 years of age (the age-range of the men in the plco and erspc trials) possessing indolent or clinically insignificant cancers 9 , the detection of prostate cancer by psa test, given its absence of cancer specificity, has more than likely been a serendipitous observation. Therefore, based on the initial studies of psa 5–7 and the subsequent observations of one of us (RJA), the interim results from the plco and erspc trials showed exactly what we would have expected. Although the erspc study was " designed to show a 25% statistically significant reduction in possible prostate cancer mortality after screening " 10 , it found only a 20% reduction in mortality. In addition, if the inconsistencies between erspc study sites—method-ology, frequency of screening, and psa cutoff points (that is, 3.0 vs. 4.0) as an indication for biopsy—are looked at, the data may reasonably be questioned. With further reference to the 20% reduction in pros-tate cancer mortality between the screened and the unscreened groups, the assumption is made that, even The purpose of screening is to identify preclinical and asymptomatic cases of a disease …