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PSA USE SHARPLY QUESTIONED
Ralph W. Moss, Ph.D. Weekly
CancerDecisions.com
Newsletter #94 10-08-03
Another pillar of the cancer establishment is
tottering. The widely used Prostate Specific Antigen
(PSA) blood test, designed to detect prostate cancer
while it is still in its early stages, has been found
to miss 82 percent of tumors in men under 60, and 65
percent of cancers in older men, according to a recent
study published in the New England Journal of Medicine.
At the present time a reading under 4.0 is considered
the sign of a healthy prostate. But scientists at
Harvard Medical School and elsewhere have responded to
these findings by suggesting that the cut-off point for
a "healthy" PSA score should be lowered to 2.6. Indeed,
the Prostate Cancer Coalition already advocates
checking men with lower PSA levels. If this new
yardstick were generally adopted, it would mean that
thousands more men every year would be told to have
surgical biopsies to see if they really have prostate
cancer. Many more men who do not have prostate cancer
would undergo these biopsies just to make sure.
The PSA test was approved by the FDA in 1986 and was
purported to have an 80 percent rate of accuracy in
detecting prostate cancer in its early phase. However,
studies have repeatedly shown that the PSA test is
decidedly unreliable. In up to 82 percent of cases of
men under 60 years of age who actually do have prostate
cancer, the PSA test gives a normal reading (4.0 or
below). Conversely, in 12 percent of men who do not
actually have prostate cancer, the PSA test will give a
suspicious reading of 4.1 or above. Other conditions,
such as prostatitis (inflammation of the prostate
gland) can lead to false positive readings.
If the "healthy" score were lowered to 2.6, scientists
say, then the percentage of men without cancer who
would be subjected to an unnecessary biopsy would rise
from 2 percent to 6 percent.
The widespread use of PSA screening has created a boom
in biopsies, according to the January 2002 issue of the
journal Urology. Lowering the normal score by several
points will generate even more office traffic for
urologists. But will it really save the lives of those
who submit to it? In an editorial in the same issue of
the New England Journal of Medicine, Drs. Fritz
Schroder and Ries Kranse of the Erasmus Medical Center
in Rotterdam, Netherlands, say no. They point out that
there is no conclusive evidence showing that the PSA
screening test actually reduces the risk of death from
prostate cancer, without reducing many men's quality of
life.
There is no doubt that we need a way to detect
aggressive prostate cancer. Prostate cancer kills about
29,000 American men each year and is the second most
common cancer killer of US men, after lung cancer.
However, there are so many problems with the PSA that
it can really no longer be considered a reliable means
of finding early but life-threatening cancer. To
complicate matters even further, many experts point out
that prostate cancer is usually a slow-growing disease
and in fact, in older men, often does not require any
treatment at all, except "watchful waiting."
The very name "Prostate Specific Antigen" implies that
this marker is found only in prostate tissue.
However, in 1995 scientists at Fox Chase Cancer Center,
Philadelphia, showed that genetic material (RNA)
contained in PSA was also present in several
non-prostate cell lines, including ovarian cancer, lung
cancer, myeloid leukemia, as well as occasionally in
normal blood. Oddly, Canadian scientists have also
found this "prostate-specific" marker expressed by
female breast cancers (Zarghami 1996). So the idea that
PSA is specific to prostate cancer is inaccurate, to
say the least.
I am not saying that PSA tests are worthless. In fact,
they are still very important in diagnosing the
progress of the disease, once established. But PSA is
what scientists call a "dynamic measure." What is
really important is how it changes over time. A rising
PSA, for example, is a valuable indicator that the
cancer is progressing. And a PSA above zero in a man
whose prostate has been removed is usually an
indication of recurrent disease. But as an absolute
measure it is of doubtful value, and may now lead to a
tremendous extension of surgical biopsies. This is a
questionable development.
In a prostate biopsy, a visualizing device, called a
transrectal ultrasound (TRUS), is inserted into the
rectum, and a tiny needle is threaded through the
rectal wall and into the prostate. Most doctors take
six samples, but others take as many as 45 samples of
the prostate in a needle-in-the-haystack search for
cancer. The more elaborate biopsy requires anesthesia.
Everyone agrees that the procedure hurts, although many
urologists downplay the pain, claiming that the
prostate isn't especially sensitive to pain. (This will
come as a surprise to any man who has suffered through
a bout of prostatitis.) Researchers at Emory University
have suggested that the common pain reliever lidocaine
gel can significantly improve a patient's comfort.
After the biopsy there may be blood in the urine,
stools, or semen for days.
According to the University of Pittsburgh Cancer
Institute, fewer than 1 percent of all patients develop
severe bleeding or an infection of the prostate or
urinary tract following biopsy. However, the key word
here is "severe." Another study done at the Mayo Clinic
showed that of 2,258 prostate biopsies, 17 percent were
associated with at least one complication.
The total number of complications per biopsy remained
relatively constant between 1980 and 1997. But the
age-adjusted complication rate (per 100,000 men) during
this period more than doubled, from 26 to 60. This is
because the use of prostate biopsies also more than
doubled in the same period, from 138 per 100,000 to
374 per 100,000.
"The prevalence of post-biopsy complications in the
community has increased tremendously because of the
increased use of prostate biopsies," the Mayo authors
reported. One can predict that if the normal PSA score
is reduced from 4.0 to 2.6, as proposed, this will
contribute even more to the rising number of biopsies,
as well as increasing the incidence of complications
needing further treatment.
I don't have any simple solution to the PSA dilemma.
However, I hope that medical practitioners will take
another look at the old-fashioned but nonetheless
useful method of digital rectal examination (DRE),
which, for all its limitations, at least does not poke
holes in a sensitive organ, nor frequently cause
complications, as does needle biopsy.
What will doctors do about patients (and they number in
the thousands) who have had a relatively stable PSA
score between 2.6 and 4.0? Are they really going to
send all of those men for painful and potentially
dangerous biopsies? And will men willingly submit to
such invasive procedures? I hope not.
Once again, I lift my eyes to Heaven and exclaim,
"There's got to be a better way!"
======================================
References:
Djavan B, et al. Safety and morbidity of first and
repeat transrectal ultrasound guided prostate needle
biopsies. The Journal of Urology. September 2001. 166:
856-860.
Emery, Gene. Prostate Test Misses Tumors, Study Finds.
Reuters. Wed July 23, 2003.
Issa, MM, et al. A randomized prospective trial of
intrarectal lidocaine for pain control during
transrectal prostate biopsy: the Emory University
experience. Journal of Urology 2000: August; 164 (2):405.
Roberts RO, Bergstralh EJ, Besse JA, Lieber MM,
Jacobsen SJ. Trends and risk factors for prostate
biopsy complications in the pre-PSA and PSA eras, 1980
to 1997. Urology. 2002 Jan;59(1):79-84.
Smith MR, Biggar S, Hussain M. Prostate-specific
antigen messenger RNA is expressed in non-prostate cells:
implications for detection of micrometastases. Cancer Res.
1995 Jun 15;55(12):2640-4.
Zarghami N, Diamandis EP. Detection of prostate-specific
antigen mRNA and protein in breast tumors. Clin Chem. 1996
Mar;42(3):361-6.
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