Data show low morbidity of high-intensity focused ultrasound in short-term trials

Key Points

Berlin-Recent studies from around the world provide encouraging evidence of the safety of high-intensity focused ultrasound (HIFU) as a minimally invasive treatment for localized prostate cancer. All of the studies had short-term follow-up, however, and one study group reported disease recurrence in approximately 25% of treated patients.

At the 2011 Société Internationale d'Urologie congress in Berlin, researchers from three continents shared their findings about the treatment, which is approved in Europe but not the United States.

A multicenter study known as ENLIGHT, led by first author Cary Robertson, MD, of Duke University, Durham, NC, found low morbidity following transrectal Ablatherm HIFU (EDAP TMS, Lyon, France) in a North American investigation with institutional review board approval.

The average patient age was 65 years and the pre-surgical PSA was 4.7 ng/mL. The Gleason score was 6. The preponderance of subjects had stage T1c tumors. Follow-up was 15 months.

Pre-treatment, 1-, 6-, 12-, and 24-month International Prostate Symptom Scores were 16.8±8.91, 10.5±7.98, 8.78±6.77, and 7.96±6.25, respectively. Among patients who were pad free prior to treatment, pad-free rates at the post-treatment time points above were 66%, 84%, 92%, and 93%. At 24 months, 38% of patients reported full potency and 21% partial potency.

No rectal injuries or fistulas were reported.

"HIFU has low morbidity," said Dr. Robertson, associate professor of surgery at Duke. "Urinary retention has been the most bothersome early adverse event, with resolution in most cases within 3 months. The potency rate is similar to other therapies, and the incontinence rate is low. The lack of any serious morbidity, specifically fistulas, which can be considered essentially historic for HIFU, is encouraging, as is the recovery of both sexual function and continence with time.

"When you look at low-risk, low-grade prostate cancer," Dr. Robertson added, "you are comparing that population that would be selected for active surveillance, so it is a fair question to ask what is the price one pays for the assurance that cancer control will be enhanced."