New Urine Test for Prostate Cancer
Hailed as Best Ever and Easily Available by Mail
shows the two-marker urine test is more effective than PSA test alone,
or PSA testing that’s incorporated into a commonly used online tool -
the Prostate Cancer Risk Calculator
Sept. 25, 2013 - A new urine test
for prostate cancer that measures minute fragments of RNA is now
commercially available to men nationwide through the University of
Michigan Mlabs, according to a news release issued by the Prostate
Cancer Foundation. The new test - Mi-Prostate Score (MiPS) - improves
the utility of the PSA blood test, increases physicians’ ability to pick
out high-risk prostate tumors from low-risk tumors in patients, and may
help tens of thousands of men avoid unnecessary biopsies.
The MiPS test incorporates blood
PSA levels and two molecular RNA markers specific for prostate cancer in
one final score that provides men and their doctors with a personalized
prostate-cancer risk assessment.
Drawbacks of stand-alone PSA
testing for prostate cancer
• The prostate specific antigen (PSA)
is a protein made by the prostate. For decades the PSA test has been
used as a marker for the presence of prostate cancer in men - high or
rising levels of PSA in blood may indicate the presence of a prostate
However, the PSA test is a
non-specific test for prostate cancer. That is, non-cancerous conditions
such as an enlarged or inflamed prostate can cause elevations in PSA
levels. And even when PSA levels rise above what has routinely been
considered a trigger level (4.1 ng/ml in the blood) indicating the need
for a needle biopsy to check prostate tissue for signs of cancer, less
than half of those biopsies find cancerous cells.
In addition, up to 44 percent of
PSA-triggered biopsies find cancer cells that are non-lethal, indolent
prostate cancer cells. Indolent prostate cancer is highly unlikely to
shorten the lifespan of a man. However, treatment with surgery or
radiation can carry significant risk of side effects such as
incontinence or sexual dysfunction.
Improving upon the PSA test
• The limited reliability of the PSA
test, and its lack of specificity for prostate cancer, has led to sharp
disagreement over the use of the PSA test as a routine health screening
measure for men of a certain age. What everyone does agree upon is the
need for better markers of prostate cancer.
To date there are no perfect
biomarkers that identify only high-risk prostate cancer. But each year
progress is made toward such a goal. Today, the University of Michigan’s
Department of Pathology MLabs will begin offering the MiPS urine test
that is ultra specific for prostate cancer.
The MiPS test scans urine samples
for two molecular markers that are distinct to prostate cancer. One
marker is a snippet of RNA made from a gene (PCA3) that is overactive in
95 percent of all prostate cancers. The second marker is RNA that is
made only when two genes (TMPRSS2 and ERG) abnormally fuse. The presence
of this fusion RNA in a man’s urine is ultra specific for prostate
An ultra-specific test for
• Dr. Scott Tomlins, MD, PhD, is an
assistant professor of pathology and urology at the University of
Michigan and a Safeway-Prostate Cancer Foundation Young Investigator.
Tomlins co-discovered what is now commonly known as the TMPRSS2:ERG
fusion. “The evidence shows that if TMPRSS2:ERG RNA is detectable at
high levels in urine, a man likely has prostate cancer, whether or not
his biopsy is positive for cancer,” said Tomlins. (Because biopsies
typically sample less than 1 percent of the prostate gland, cancers can
be missed, even high-grade cancers.)
A commercial urine test (PROGENSA
PCA3) for PCA3, developed and marketed by the California-based biotech
company Gen-Probe, gained FDA approval in 2012 for use in men who are
considering repeat biopsy after an initially negative result. While a
welcome development, research shows that the new urine test offered by
MLabs that measures both PCA3 and TMPRSS2:ERG should improve a doctor’s
ability to stratify men suspected of having prostate cancer.
In a study published in Science
Translational Medicine, Tomlins and colleagues found the highest rates
of cancer in men with the highest levels of TMPRSS2:ERG and PCA3 in
The men in the study were stratified into three groups
based upon the levels of TMPRSS2:ERG and PCA3 in their urine: low,
intermediate and high levels, or scores. Cancer was diagnosed in each of
the groups respectively: 21%, 43%, and 69%.
High-grade prostate cancer, defined
in the study as a Gleason score greater than 6, also occurred at
different frequencies in the three groups with 7%, 20%, and 40%
diagnosed in each group respectively.
Other research has shown that the
two-marker urine test is more effective than the PSA test alone, or PSA
testing that’s incorporated into a commonly used online tool (the
Prostate Cancer Risk
Calculator), at predicting the presence of prostate cancer.
How to be tested at your
For additional research results of
the MiPS test, how results will be presented to men and their doctors,
and other background information, click
The test is available to anyone but
requires a request from a doctor. For further information, call the
University of Michigan’s MLabs at 800-862-7284 or visit www.mlabs.umich.edu.
The Prostate Cancer Foundation
notes in its news release that it is not endorsing the use of this test,
since PCF does not endorse commercial companies or products.
The Foundation says it does
“heartily applaud” each research step made toward precision medicine and
better biomarkers for prostate cancer that improves the standard of care
for patients and leads to less suffering and death from this disease
that will affect one in six men in the US.
Foundation provided unrestricted funding to the Prostate
Cancer Foundation for biomarker research that funded this work. The
Safeway Foundation also provided PCF-Young Investigator funding to Dr.
From more information on how to
send a specimen, call MLabs at 800-862-7284 or visit
The Prostate Cancer Foundation is
the world’s largest philanthropic source of support for accelerating the
most promising research for better treatments and cures for prostate
cancer. To learn more about PCF go to
All aggressive therapies for prostate cancer have
significant side effects and perhaps these data make an argument for
active surveillance (avoiding aggressive treatment and closely following
the cancer) in certain cases
Jan. 30, 2013
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