HOLLI W. HAYNIE

For the past 10 years, other countries have been offering prostate cancer patients a minimally invasive procedure known as HIFU (high intensity focused ultrasound), a precise and targeted therapy using sound waves to ablate a focused area of cancerous prostate tissue.

International studies suggest a substantial reduction in side effects common with traditional treatments such as surgery, radiation and cryotherapy, namely impotence and incontinence. In March, Baptist Memorial Health Care, in partnership with the Southeast Urology Network (formerly known as UroCenter), became the first site in the nation approved by the Food and Drug Administration for a phase III clinical study to test this therapy.

The ultrasound device, the Sonablate® 500, elevates tissue temperature to more than 195 degrees Fahrenheit in seconds, destroying diseased tissue without damaging the surrounding tissue, similar to the way a magnifying glass focusing the rays of the sun burns a piece of paper. Precision is within 3 millimeters, which significantly lowers the side effect profile, allowing physicians to identify the nerves for erection and urination.

When urologist Dr. Michael Alabaster of Southeast Urology Network began checking it out for himself in Mexico three years ago, he became enthusiastic with the results and encouraged colleagues to get involved. Not only are the cure rates comparable to traditional treatments, but the side effect profile was better and recovery time was much less.

"There were 20 people a weekend paying out of their pockets. They could have the procedure done and be at the beach or a restaurant the same night," Alabaster recalled, observing the typical patient was highly educated, some of them doctors. "They could go anywhere for their treatment and they began going offshore."

This trial will compare the benefits of HIFU versus cryotherapy in particular. HIFU is minimally invasive with minimal recovery. The procedure is performed on an outpatient basis with an epidural and the treatment takes only one to three hours. Patients are typically up and walking within a few hours after the procedure and back to normal within a day or two. After the initial assessment, patients are followed up every three months for two years. HIFU should only be needed once, but if the cancer does return, patients can be retreated. The most common side effect is urinary retention due to swelling caused by the dead tissue. Patients wear a temporary catheter for two to three weeks and then it's removed.

Alabaster surmised medicine is probably over-treating prostate cancer, which may be due to the fact that the aggressiveness of the cancer is hard to definitively identify.

"It's sort of like we've been hitting an ant with a jackhammer when we do radical prostatectomies on people 70 years old," said Alabaster, "so why wouldn't somebody want to choose a minimally invasive procedure with low side effects?"

There is still a place for radical prostatectomy, radiation and cryotherapy, but HIFU is showing itself to be superior in overall outcomes. With total gland cryotherapy, for instance, patients are going to be impotent 100 percent of the time, explained Alabaster, with current studies suggesting only 50 percent regained in three years. With a radical prostatectomy, if the cancer comes back, patients cannot use HIFU or cryotherapy as an option.

"HIFU will be a very attractive option in our total armament of treatment options," said urologic oncologist Dr. Walter Rayford, who was a transplant to Southeast Urology Network from the University of Louisiana after Hurricane Katrina. He added patients who would not have been able to undergo a prostate procedure can do HIFU because of the minimal invasiveness and lack of adverse side effects. "I think it will eventually compete with radical prostatectomies in the future."

What that can mean for patients only time will tell. But for Alabaster, his experiences with the technology and the success of HIFU inspired him to change the way he counsels patients. When patients asked what treatment he would choose if it were him, he used to tell them he couldn't make the decision for them.

"Now I feel pretty good that I could say I would try HIFU before I did anything."

Eligible participants for the trial must be between the ages of 40 and 75, have a biopsy confirmed, confined prostate cancer with a prostate specific antigen of less than or equal to 10 and a Gleason score of less than or equal to 6, and a prostate volume of less than 40 cc. If interested in applying for your patient to be in the study, contact the Southeast Urology Network clinical research nurse at (901) 527-7100.


June 2007