Charlotte company hopes to bring prostate surgery alternative to U.S.
A Charlotte company that shares ownership of a device used to treat prostate cancer in other countries has received approval to expand testing of the treatment in the United States.
The device, called Sonablate 500, uses high-intensity focused ultrasound (HIFU) as an alternative to surgery.
The treatment is approved in Japan, China and other countries, including most of Europe. But it is still considered experimental for prostate cancer in the United States and can be used here only as part of a clinical trial.
This month, the U.S. Food and Drug Administration approved the Charlotte company’s device for use in a Phase III study to determine effectiveness. The study will involve 466 patients at 24 sites, possibly one in Charlotte.
To qualify, patients must be newly diagnosed with early-stage prostate cancer that has not spread from the walnut-sized gland. Half the patients will receive
Patients will be followed for two years, and results could be available in three years, after which FDA approval will be sought.
“This is the last hurdle toward our goal of bringing
The younger Puckett became interested in
Puckett Jr. said
Suarez, who helped start U.S. HIFU, is medical director of the company and performs the treatment in other countries.
Several Charlotte-area patients have traveled to Mexico and the Dominican Republic for the treatment, and several local doctors have gone there to learn the technique.
Darrell Bunch, 50, of Fort Mill, S.C., said he chose
Since the treatment, his level of PSA (prostate-specific antigen) has dropped from 10 to 0.01. “You can’t get any lower than that,” he said.
“Considering what my options were, I really think I chose the best,” Bunch said. “It’s a shame that I had to go outside the country. They’ve been doing this in Europe, Germany and Japan for a long time.”
Dr. Chris Teigland, a urologist and researcher at Carolinas Medical Center, spent a weekend in Mexico this spring learning the technique and is negotiating with U.S. HIFU to be part of the Phase III study.
The treatment is “easy on the patients,” Teigland said. “One thing that’s remarkable is how quickly they bounce back.”