Focused ultrasound treatment for the prostate is available in the United States.
Three focused ultrasound systems for destroying diseased prostate tissue are approved by the Food and Drug Administration. In addition, Medicare has taken steps to cover this treatment, which will hopefully impact the commercial carriers to do the same.
Focused Ultrasound Therapy
Focused ultrasound is a noninvasive, 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 primary options for treatment of prostate cancer include invasive procedures that may include ionizing radiation and surgery.
For certain patients, focused ultrasound could provide a noninvasive, radiation-free alternative to surgery with less risk of complications and lower cost.
- Focused ultrasound is a noninvasive, low-morbidity treatment with a short recovery time and a quick return to work and the activities of normal life (usually the next day).
- Precise targeting minimizes damage to non-targeted healthy tissue.
- 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, and it is possible to offer it as a salvage therapy for patients who fail radiation treatment.
- Treatment can be a complement to drug therapy, enabling enhanced delivery of chemotherapy or immunotherapy to tumors.
- Focused ultrasound may potentially induce an anti-tumor immune response.
There are numerous clinical trials worldwide using focused ultrasound to treat prostate cancer.
Regulatory Approval and Reimbursement
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. Find a center near you >
There are two focused ultrasound manufacturers that are approved in the US for the ablation (destruction) of prostate tissue – SonaCare and EDAP-TMS. These systems deliver care outside of the MRI facility, so they are found in surgery centers and surgical suites, as well as in hospitals. There are even some mobile units that provide care adjacent to physicians' offices.
While the Foundation attempts to keep the list of sites complete, there have been many purchases of the focused ultrasound systems. For the latest information on availability, we recommend contacting the manufacturers’ search links, at EDAP-TMS and SonaCare Medical.
There are additional sites that use mobile focused ultrasound equipment. These sites may not be listed on the EDAP or SonaCare sites, and the best way to find them is to contact local urologists to see if they have focused ultrasound capability.
Profound Medical has a transurethral MRI guided device that is FDA approved in the US, and they will be launching clinical sites in the US in late 2019. See the press release >
This device is also approved in Europe and Oceana.
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Click here for additional references from PubMed.
Video courtesy of SonaCare Medical