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William K. Oh, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber.
A new blood test used in combination with a conventional
prostate-specific antigen (PSA) screening sharply increases the accuracy
of prostate cancer diagnosis and could eliminate tens of thousands of
unneeded, painful, and costly prostate biopsies annually, according to a
study led by researchers at Dana-Farber Cancer Institute.
At the annual meeting of the American Society of Clinical Oncology in
Orlando, Fla., William K. Oh, M.D., and Robert W. Ross, M.D., will
report that the six-gene molecular diagnostic test, when combined with a
PSA test, accurately detected prostate cancer more than 90 percent of
the time. Earlier studies suggest that the conventional PSA test is
60-70 percent accurate in detecting cancer.
The findings (abstract #5052) will be discussed at a poster session on Sunday, May 31, 8-11 a.m., Level 2, W230A.
Men who are found to have elevated levels of PSA in routine screening
tests are often referred for a biopsy of the gland to check for tumors.
Nearly two-thirds of biopsies performed — a painful procedure with some
risk of complications — do not find any cancerous cells. This high rate
of "false positive" PSA test results underscores the need for a more
accurate method for detecting prostate cancer, said Oh, who is the
clinical director of the Lank Center for Genitourinary Oncology at
The two-year study involved 484 participants. The group comprised 204
men with known prostate cancer, 110 men with benign prostatic
hypertrophy (BPH), and 170 healthy men in a control group. (BPH can
elevate PSA levels in the blood, which often leads to a biopsy to rule
out prostate cancer.) These groups were split into age-matched training
and validation sets.
The researchers sought to measure the accuracy of a six-gene whole
blood RNA transcript-based diagnostic test developed by Source MDx in
Boulder, Colo., both in terms of its sensitivity (the ability to detect
prostate cancer) and specificity (the ability to identify people who
don't have prostate cancer).
Source MDx researchers developed the test after initially working
with a set of 174 candidate genes whose activity was compared in the
different study groups. They narrowed the pool down to just six genes
that, as a group, were highly sensitive in predicting which patients had
prostate cancer and which were normal.
The study found that "the six-gene model was more accurate than PSA
alone at predicting cancer if you had it and no cancer if you didn't,"
said Oh. The test's accuracy improved even more when PSA measurements
were added. Combined, the two tests achieved a diagnostic accuracy of
more than 90 percent in specificity and sensitivity and eliminated most
of the false-positives yielded by the PSA test.
Based on these findings, the researchers are planning to conduct a
larger, multicenter clinical trial involving approximately 1,000 men to
determine if the findings remain valid.
"These findings are very encouraging and suggest that this new test
could spare tens of thousands of men from undergoing an unnecessary
biopsy," Oh said. "However, until we can verify our findings, it is
important to recognize that the PSA test, despite its limitations, is
still the best test available for diagnosing prostate cancer at this
The study was funded in part by Source MDx and a Prostate Cancer SPORE grant at Dana-Farber/Harvard Cancer Center.