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As noted above even a PSA over 2.5 may be cause for a biopsy (not 4.0 as
commonly thought) see editorial below:
Verification Bias and the Prostate-Specific Antigen Test Is
There a Case for a Lower Threshold for Biopsy?
Fritz H. Schröder, M.D., Ph.D., and Ries Kranse, Ph.D.
NEJM 2003349:393
Punglia used a logistic-regression model that included all available variables
that can affect the diagnosis of prostate cancer. The information obtained by this
analysis of the 705 men who underwent a prostate biopsy was used to assess the probability
of detecting prostate cancer by means of a biopsy in all 6691 men in the cohort. These
probabilities were then used to calculate the sensitivity and specificity of specific
threshold PSA values.The differences between the uncorrected and corrected PSA results
were considerable, especially for younger men. Punglia et al. found that if biopsies were performed only when the PSA value was higher than 4.0 ng
per milliliter, 82 percent of cancers would be missed in men who were younger than 60
years of age, and 65 percent would be missed in those who were 60 or older.
Should we further decrease the PSA threshold and the age at which a prostate biopsy is
recommended, as Punglia et al. suggest?
These findings are difficult to apply clinically. Clinicians want absolute numbers that
show the effect of lower PSA cutoff points with respect to the detection rate, number of
cancers missed, and number of cases requiring a biopsy if all cancers that could be
detected by biopsy were diagnosed. Such data have been obtained in a study of a
consecutive sample of 8621 men between the ages of 55 and 74 years who participated in the
European Randomized Study of Screening for Prostate Cancer and who were screened by means
of a digital rectal examination, transrectal ultrasonography, and a PSA test, with a
threshold value of 4.0 ng per milliliter for biopsy. A priori prevalence assessment (the
estimated probability of detecting prostate cancer on the basis of the outcome of the PSA
test, prostate volume, digital rectal examination, and transrectal ultrasonography before
biopsy) showed that in this sample, in which 93 percent of all indicated biopsies were
carried out, 31.9 percent of prostate cancers were missed is evident that below the
threshold value of 4.0 ng per milliliter on the PSA test, most cancers were missed by
digital rectal examination and transrectal ultrasonography. The proportion
of missed cancers was 69.2 percent at a PSA value between 0 and 2.9 ng per milliliter and
46.8 percent at a value between 3.0 and 3.9 ng per milliliter, but
cancer-detection rates were exceedingly low when the PSA value was below 2.0 ng per
milliliter.
At first glance, the recommendation to lower the age limit for prostate-cancer
screening to less than 50 years seems sensible. The deaths from prostate cancer that occur
in men 60 to 70 years of age could be prevented by screening at an earlier age, and the
number of life-years saved is greater in these younger men. However, the number of tests
that would need to be done would be excessive because of the low incidence and the
resulting low detection rates.
A mechanism that identifies young men with a high likelihood of having clinically evident
prostate cancer later in life would be helpful. A study of 1634 men showed that a positive
family history (a father or brother with prostate cancer) doubled the risk of clinically
evident prostate cancer. Another study, however, showed that among men who were 40 to 49
years old, the frequency of PSA values above 2.5 ng per milliliter did not differ
according to the presence or absence of a family history of prostate cancer; only 3 of the
343 men in the study were found to have prostate cancer (0.9 percent).A third study
suggests that a more powerful way of identifying men who should be screened at a younger
age may be to perform a PSA test at approximately 40 years of age,
regardless of the family history: a PSA value of greater than 0.60 ng per milliliter
(found in 177 of 351 men between the ages of 40 and 49) was associated with a relative
risk of 3.6 with respect to the development of prostate cancer within 25 years.
Important questions that remain to be answered are whether the detection of missed cancers
will reduce mortality and improve the quality of life among treated patients. Predictions
based on prognostic indicators have limited value. A large, randomized study of men with
locally confined prostate cancer that was detected clinically (not by screening) showed a
significantly lower rate of death from prostate cancer in the group of men who underwent
radical prostatectomy than in the watchful-waiting group. After eight years of follow-up,
however, the death rate from prostate cancer in the watchful-waiting group was only 13.6
percent, and it was necessary to treat 17 men to prevent 1 death from prostate cancer
eight years after the diagnosis.
The recommendation to lower the PSA threshold for performing a prostate biopsy to a value
below 3.0 or below 2.5 ng per milliliter must be considered on the basis of the
characteristics of the PSA test and its overall diagnostic performance. Lowering the PSA
threshold for performing a biopsy will increase the rate of overdiagnosis and,
potentially, overtreatment. This recommendation is not ready for routine clinical
practice. New recommendations for screening should arise from ongoing, randomized studies
that are designed to show whether screening indeed reduces mortality from prostate cancer
without unacceptably reducing the quality of life. |