More Sites and Patients Join Clinical Trial Assessing New MR-guided FUS System for Prostate Cancer


Vendor Update: InSightec, Ltd., Israel 

InSightec reports that two new sites have joined its Phase 1 clinical trial assessing the ExAblate Prostate System and 14 patients with low-risk prostate cancer have now received treatment.

The newly added sites are the University of Rome in La Sapienza, Italy; and Jaslok Hospital in Mumbai, India. The other participating sites are the N.N. Petrov Research Institute of Oncology in Saint Petersburg, Russia and the National Cancer Centre at the Singapore General Hospital, Singapore.

Kobi Vortman, Ph.D., President and CEO of InSightec, says his company has spent the last three years developing the system, which he describes as a “new breed” of MR-guided focused ultrasound therapy. The goal, he says, was to design a system that changes the “tight correlation” between treatment effectiveness and unwanted side effects for patients with low and intermediate-risk prostate cancer.

“Prostate cancer is suffering today not from lack of technology that could treat it, but from significant adverse events,” he observes. “The most common are impotence and incontinence, and they are severe.

Almost 85 percent of prostate tumors occur in the peripheral zone, near the neurovascular bundle and sphincter. “Those are very critical areas,” Vortman says, “and are perceived to be responsible for the adverse events.”

To increase effectiveness and safety, InSightec has equipped the ExAblate Prostate System with a very high density phased-array endorectal transducer. “We are speaking about 1,000 elements that will allow very accurate, millimeter-resolution treatments near the areas responsible for urinary continence and potency, namely the external sphincter and the neurovascular bundles,” Vortman says.

Like other ExAblate systems, the prostate module uses a high intensity focused ultrasound beam and real-time MR imaging to visualize the tumor, surrounding tissue and the energy delivery path. Real-time 3D MR thermometry provides accurate closed-loop monitoring of temperature parameters. It also allows clinicians to make adjustments during treatment based on a patient’s specific tissue characteristics, providing a form of personalized therapy.

“We are hoping to finish Phase I during in the 2011-2012  timeframe and then develop Phase II and III,” Vortman says. “We are focusing on low and intermediate-low-risk patients now. Eventually, we will need to address both mid-risk and high-risk patients.”        – Written by Ellen C., McKenna

Click here to view recent clinical trial update by Prof. Christopher Cheng, Singapore General Hospital, Singapore.

View animation of InSightec prostate treatment: