FUS and the Prostate


Prostate ablation is the leading application of focused ultrasound, having been used to treat benign prostatic hyperplasia (BPH), partial gland cancer, localized whole-gland cancer, and recurrent cancer. While HIFU may be helpful, active surveillance may be the most appropriate approach for early disease. In cases where the physician recommends treatment or the patient prefers treatment, focused ultrasound may be a good alternative.

Focused ultrasound can be considered a non-invasive therapy as the actual treatment does not involve any direct cutting of the skin and there is no physical “removal” of prostate tissue. The probe for delivering the treatment is inserted into the rectum on current FDA approved systems and it does not utilize ionizing radiation. Using real-time imaging guidance, the physician directs a focused beam of ultrasound energy to a selected volume in the patient’s prostate gland. The energy heats the targeted tissue at the focal point and creates a temperature elevation that thermally coagulates the targeted cells within seconds. This process is repeated until the entire selected volume or the entire gland is destroyed.

Focused ultrasound treatments are performed with no incisions, leading to fewer severe complications and minimal discomfort, and enabling patients to return to daily activities more rapidly.

More than 50,000 men around the world have been treated with focused ultrasound for prostate cancer. Please note that while the studies that were used to establish approval of HIFU for prostatic tissue ablation in the USA were performed in a patient population with prostate cancer, the evidence accumulated in those studies was insufficient to support FDA approval of a prostate cancer treatment claim because the studies were unable to provide reasonable assurance of safety and effectiveness that HIFU ablation results in long term direct clinical benefit.

HIFU treatment centers for the prostate are now opening across the United States. In addition, there are currently 154 prostate centers in Europe, 26 in Asia, 7 in South America, and one in Africa, among other locations.

More information on focused ultrasound for the prostate can be found here.