- Last Updated: April 6, 2017
Focused ultrasound treatment for the prostate is now available in the United States. Two systems for destroying diseased prostate tissue are now approved by the Food and Drug Administration.
Focused ultrasound is a non-invasive, radiation-free method to destroy prostate tissue and treat prostate disease. Using real-time image guidance, the physician directs a focused beam of ultrasound energy to a selected volume in the patient’s prostate gland. The energy heats and destroys the targeted tissue at the focal point within seconds. This process is repeated until the entire selected volume or the entire gland is destroyed.
The technology has been successfully used to treat a wide variety of prostate related diagnoses, including benign prostatic hyperplasia (BPH) and prostate cancer. Focal prostate gland ablation or diffuse prostate gland ablation is possible depending on the clinical scenario. More than 50,000 men around the world have been treated with focused ultrasound for prostate cancer. It is the leading clinical application of the technology -- more than 50% of all focused ultrasound procedures performed to date were for prostate cancer.
There are two focused ultrasound systems approved in the US for the ablation (destruction) of prostate tissue - SonaCare’s Sonablate and EDAP’s Focal One.
About Prostate Disease
The prostate gland is the part of the male reproductive system that produces the ejaculatory fluid that carries sperm cells. It is about the size of a chestnut and is internally located around the urethra directly below the bladder.
Prostate cancer is the fourth most common cancer worldwide. It can affect the entire prostate or just a small portion of it, and the severity of the disease is based on a combination of the scores from the screening tests (PSA, rectal examination, and biopsy). If diagnosed early, prostate cancer is very treatable. In the US, prostate cancer is the most common type of cancer in men, with 190,000 new cases and 28,600 deaths reported each year. It is the second leading cause of cancer death in American men, behind lung cancer.
With aging, the prostate may enlarge for unknown reasons, resulting in a condition called benign prostatic hyperplasia (BPH). It is the most common disorder of the prostate gland and is particularly common among older men. According to the National Institutes of Health, BPH affects approximately 50 percent of men between the ages of 51 and 60, and up to 90 percent of men older than 80 years in the United States. BPH is not cancerous, but it can cause many different urinary problems, such as frequent urge to urinate, difficulty urinating or getting up at night to urinate. Although the prostate continues to grow with age, the exact cause of BPH is not known.
Some types of prostate cancer grow slowly and may need minimal or no treatment, while other types are aggressive and can spread quickly. For men with very early-stage prostate cancer, immediate treatment may not be necessary. In these situations, doctors may recommend active surveillance – frequent testing to guide decisions on if and when to intervene – or watchful waiting, a more passive approach with treatment of only symptoms. For men with localized prostate cancer requiring treatment, the choice of therapy depends on a number of factors including cancer stage, histologic grade, presence of comorbidities, and patient preferences.
Treatment options may include: radical prostatectomy (the most common treatment), radiation, androgen deprivation therapy, or cryoablation.
Radical prostatectomy involves the removal of the entire prostate gland plus some surrounding tissue, including the seminal vesicles. Radiation therapy uses high-energy rays or particles to kill cancer cells; the two main types of radiation therapy are external beam radiation and brachytherapy (internal radiation).
With hormone or androgen deprivation therapy (ADT), the goal is to reduce levels of male hormones, called androgens, in the body or to stop them from affecting prostate cancer cells.
Cryoablation, also called cryosurgery or cryotherapy, is an option for treating early-stage prostate cancer by freezing it. Each treatment option has pros and cons as well as possible side effects including incontinence and impotence. More information on prostate cancer treatments is available from the American Cancer Society.
Watchful waiting or active surveillance is common for men with BPH whose symptoms are mild. With watchful waiting, health care providers monitor patients regularly, but do not prescribe active treatment. For men with moderate to severe symptoms, BPH treatment options may include oral medications, minimally invasive procedures, and surgery. Learn more >
Potential Benefits of Focused Ultrasound
The potential benefits of focused ultrasound for the treatment of prostate cancer include:
- It is a non-invasive, low-morbidity treatment with a short recovery time and a quick return to work and the activities of normal life (usually the next day).
- A single therapy session is usually all that is required.
- It is reported to have a low complication rate, especially when considering post-procedure impotence and incontinence.
- Focused ultrasound treatment does not use ionizing radiation, which means that it is possible to repeat treatment, it is possible to offer it as a salvage therapy for patients who fail radiation treatment, and it does not prevent pursuing other treatment options.
Focused ultrasound devices have been cleared to treat the prostate in approximately 50 countries, including the United States. Several systems for focused ultrasound ablation of prostate tissue are available in various geographical regions, each differing in their guidance method (ultrasound vs. magnetic resonance imaging) and approach – transrectal or transurethral. Search this list of treatment sites to find a center near you.
There is an ongoing study evaluating histotripsy for treatment of patients with BPH. There are also several ongoing clinical trials for the treatment of prostate cancer. Please see here for a list.
One trial is investigating the safety and efficacy of a new device to treat low to intermediate risk prostate lesions. This trial is taking place at several sites in the US, including in California, Florida, Massachusetts, Michigan, Minnesota, New York, and Virginia. Click here for more trial information and contact information for each site.
While the FUS Foundation attempts to keep the list of sites complete, since approval, there have been many purchases of the FUS systems. For the latest information on availability, we recommend contacting the manufacturers. Their websites are EDAP (www.edap-tms.com) and Sonacare Medical (sonacaremedical.com).
Regulatory Approval and Reimbursement
In addition to the United States, the following geographical regions have one or more focused ultrasound devices approved for the treatment of prostate cancer as either a primary or salvage treatment: Europe, Canada, Russia, Australia, Korea, Malaysia, Indonesia, South America, and the Middle East.
Some European countries have insurance coverage; in other countries, coverage may be available on a case and site basis. In the United States, most insurance and Medicare are not covering focused ultrasound care for prostate conditions.
The following organizations offer information about BPH and prostate cancer:
- The Men's Health Network provides health promotion messages and tools, screening, educational materials, advocacy opportunities, and patient navigation to men, boys, and their families.
- The American Cancer Society provides patient support and education, research support, and advocacy opportunities.
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Video courtesy of SonaCare Medical