Two U.S. Sites will Conduct Clinical Trial of Profound Medical’s New MR-guided Thermal Ultrasound Treatment for Prostate Cancer


Vendor update: Profound Medical, Inc., Canada

As many as 30 patients with early stage prostate cancer could be treated with a new, minimally-invasive device in a clinical trial expected to begin at two U.S. hospitals later this year, says Paul Chipperton, CEO of Profound Medical, Inc. (PMI). The Toronto-based venture is commercializing intellectual property and technology licensed from Sunnybrook Health Sciences Centre.

The upcoming trial will evaluate the safety and effectiveness of the company’s innovative MR-guided thermal ultrasound device which has the ability to treat patients three to six times faster with greater accuracy and fewer side effects than existing options.

Shaped like a slim wand, PMI’s miniature applicator is inserted into the patient’s prostate through the urethra. It emits an ultrasound beam that heats up and destroys targeted tissue while performing real-time thermal mapping to control the amount of energy delivered to treatment sites.

“Because our device is as close as you physically can get to the prostate, we have the ability with our thermal ultrasound to treat more precisely and more accurately than anybody else,” Chipperton explains.

Treatments, he says, are expected to be performed on an outpatient basis in less than thirty minutes under conscious sedation. Increased accuracy should translate into a significant reduction in impotence and incontinence – commonly-experienced side effects caused when critical structures near the prostate are damaged during treatment.

“It’s been very important for us to differentiate away from the term, high intensity focused ultrasound, or HIFU. That technology uses multiple transducers on an array and directs energy to a fixed focal point, at a fixed focal length where a specific pre-determined temperature will be achieved.” he adds.

“Our device is a blend of two of the leading techniques for imaging and treatment. We use MRI as the best imaging modality to see the target organ. We marry that in a unique way with thermal ultrasound which is a well known and well understood treatment modality.”

Chipperton says that PMI’s technology uses  a simple linear array, where each transducer in the series generates a collimated thermal ultrasound beam with variable depth control. This provides the urologist or oncologist with a tool that matches the unique contours of each prostate and achieves a finely-tuned, real-time delivery of energy in 3D.

The technology was developed by Michael Bronskill, Ph.D. and Rajiv Chopra, Ph.D., of the Imaging Research lab at Sunnybrook Health Sciences Centre in Toronto. Last year, urologic oncologist Laurence Klotz, M.D. of Sunnybrook successfully completed a proof-of-concept study that treated eight patients with a device prototype.

PMI is now on the verge of launching its own clinical trials. “We are looking at two sites in the United States to get an understanding of how the instrument and the technology work in different hands. I think that’s always important to learn early in the stages of developing a technology,” Chipperton notes. “Twenty to 30 volunteer patients will be treated in that clinical trial.”

The company is also planning clinical trials in Canada and Europe.

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Written by Ellen C., McKenna