MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Prostate mechanical imaging
may improve cancer detection
By LYNN YOFFEE
Medical Device Daily Staff Writer
The diagnosis and treatment of prostate cancer is rife
with controversy. Because it’s such a slow-growing cancer
and therapy carries significant risks, a case can be made to
skip treatments altogether. But for men whose prostate
cancers happen to be fast growing – or near the prostate
wall – it’s imperative to get an early, accurate diagnosis.
Akin to the function of mammography, the ProUroScan
is a new medical imaging technology that creates a map or
a digital record of the prostate to identify abnormalities
detected by digital rectal exam (DRE). “When we survey the
prostate with our probe, we create a map, a 3-D picture of
what a prostate would look like,”
Rick Carlson, CEO of ProUroCare Medical
(Minneapolis), told Medical Device Daily. “Once we create
the map for any patient with any condition of any type, it
creates a baseline, which says we have a patient with a suspicious
condition and now we know where it exists.” That
map, created by this new method called prostate mechanical
imaging (PMI), can be saved as a permanent electronic
record and compared to other maps created in successive
evaluations.
The American Cancer Society (Atlanta) estimates that
there are more than two million men in the U.S. diagnosed
with prostate cancer. One out of 35 men will die from this
type of cancer, but it’s difficult to identify those with
aggressive disease. The two primary screening tests for
prostate cancer, the DRE and the prostate specific antigen
(PSA) blood test, are not 100% accurate. An abnormal result
isn’t a confirmation of cancer and a normal result doesn’t
mean cancer isn’t present. Biopsies are another option, but
unless the needle hits cancerous tissue, it can be missed.
Given these concerns and complications, ProUroCare
has taken a different approach to the diagnostic process.
“Any soft tissue organ, by definition, does not generally
have abnormal tissue formations unless there is something
going on,” Carlson said. “The map created by ProUroScan is
akin to a weather map. We’re measuring the displacement
of tissue. The more tissue you displace the lighter the color.
“Any dark formations are an indication that elasticity is
different. Over time, we’ll be able to say that tissue is not
only different, but in fact is most likely a cancer formation.
As we see changes in the sizes in the elasticity being different
it tells us if it’s expanding or moving closer to the
wall of the prostate. All are indications for physician that
you may have a more progressive disease or a more benign
disease.”
Carlson explained that PMI is not ultrasound or thermal
mapping, but a mechanical mapping done with the aid of a
probe equipped with pressure sensor arrays.
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“We would see this test being done repeatedly over
time so that a physician would be able to compare changes
that occur,” he said.
To date, nine peer-reviewed articles have been published,
the latest of which was in Urology last year. That
study, led by ProUroScan co-inventor Armen Sarvazyan,
PhD, founder and CSO of Artann Laboratories (Trenton,
New Jersey), presented data from 168 patients. In 84% of
cases, PMI provided “data sufficient for quantitative assessment
and image reconstruction of the prostate,” the study
authors wrote. “Four potential causes of the 16% failure
became apparent: anatomical limitations such as position
of the prostate relative to sphincter and/or bladder (5%),
insufficient pressure applied (5%), excessive noise from
sensors (4%), and inability of the examiner to locate the
prostate upon insertion of the probe (2%).”
PMI successfully imaged 10 of 13 malignant nodules and
was consistent with all eight reported biopsy-negative
cases. For the same group, the DRE identified six of 13 cancer-positive
cases and produced one false-positive result in
the eight non-cancerous cases. Overall, the study authors
agreed that PMI “may significantly add to the technology
diagnostic potential.” ProUroCare has since launched a new
40-patient study as required by the FDA for 510(k) approval
that’s expected to be completed in August.
If approved and launched, Carlson said the system,
basically a small computer with a probe attached, would
cost under $10,000 and would be used in a physician’s
office if either a DRE or PSA test were suspicious. “Our goals
is to make this a non-capital system purchase,” he said,
comparing it to the average $150,000 cost of an ultrasound
machine. “We would see physicians having it in their offices
and keeping their own images to compare over time.
Initially, the test (estimated to be $200) would have to
be paid for by patients out of pocket but the company
intends to pursue CPT coding. Last year, ProUroCare
entered into two agreements with Artann to complete
development, conduct clinical trials and file for FDA clearance
for ProUroScan (MDD, August 1, 2008). If ProUroScan is
approved for marketing, Carlson said the company will
seek out a relationship with a larger medical device firm for
marketing and distribution rather than building its own
sales force.
(This story originally appeared in the July 13, 2009, edition
of Medical Device Daily).
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