Site Update: Laurence Klotz, M.D, Sunnybrook Health Sciences Centre, Canada
Laurence Klotz, M.D., a urologic oncologist at the University of Toronto’s Sunnybrook Health Sciences Centre, says planning is underway for a second clinical trial using an investigational transurethral ultrasound device developed at Sunnybrook to ablate prostate cancer.
Patients participating in the new study will have their cancer treated with the device and then undergo a prostatectomy. Post-surgical assessment will determine if the device actually destroyed their cancer.
The new study will build on the results achieved in a 2009-2010 clinical trial that assessed the device’s ability to deliver ultrasound energy to a targeted area within the prostate. Eight patients were treated and then went directly to the operating room, essentially under the same anesthetic, to undergo a radical prostatectomy.
“The point of that first study was to find out what portion of the prostate was destroyed compared to what we targeted,” Klotz explains. “We found that the correlation is very tight. All the tissue that was destroyed was within about a millimeter of our target.”
He adds, “We are going step by step to really determine how well it works, if it is safe, and if we can target an area and know that it will be the only area that’s going to be treated. There are structures around that you don’t want to mess with, like the rectum and the urethral sphincter.”
Klotz says a third trial will ultimately be launched. “This is when things will really get ambitious,” he notes. “That’s when we will use our device as the treatment for the patient’s cancer. This step is probably at least a couple of years down the road.”
Addressing a huge unmet need
Sunnybrook’s device was developed to address what Klotz describes as “a huge unmet need for a minimally-invasive, relatively inexpensive treatment for men with early stage, low risk prostate cancer.”
The team at Sunnybrook, he says, “didn’t think the treatment had to be perfect, but it has to be relatively effective and it should not impose a lot of side effects on the patient.”
Klotz has conducted the clinical trials in partnership with Rajiv Chopra, Ph.D., one of the researchers who developed the new device. “What it consists of is MR-thermal mapping and a transurethral device that has an ultrasound transducer,” Klotz says. “The transducer generates ultrasound waves to create heat in the prostate, and the device maps the temperature real time.”
“Another extraordinary piece of this for which Dr. Chopra deserves all the credit is a control device that essentially uses the thermal mapping data to control the amount of energy that’s delivered,” he adds.
If clinical trials go well, Klotz believes the new device will be perceived as easy to use, highly precise and relatively fast. “The idea is you will turn it on, press the big red button that says ’start’ and the ultrasound transducer will rotate through the prostate heating the entire prostate to the point where all the cancer is destroyed. In theory, it looks like this could be done in as little as half an hour to 40 minutes.”
Klotz admits to being “quite excited” about the possibilities for the device. “The number of patients who can benefit from this treatment is huge,” he says.
Written by Ellen C., McKenna