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 initial 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.
How it Works
Focused ultrasound 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 the avoidance of invasive procedures that may include ionizing radiation and surgery.
Focused ultrasound is a low-morbidity treatment that usually only requires a single therapy session and has a short recovery time. 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. Focused ultrasound treatment can be a complement to drug therapy, enabling enhanced delivery of chemotherapy or immunotherapy to tumors, and it may potentially induce an anti-tumor immune response.
A registry for the TULSA-PRO is tracking patient outcomes for this device.
A clinical trial in Norway is comparing HIFU to active surveillance.
A clinical trial in the US is a randomized trial comparing the TULSA PRO to radical prostatectomy.
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.
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’ directly or using their online search functions.
There are four focused ultrasound manufacturers that are approved in the US for the ablation (destruction) of prostate tissue – Sonablate Corp., EDAP-TMS, Profound Medical, and Insightec. Sonablate and EDAP deliver care outside of the MRI facility, so they are found in surgery centers and surgical suites, as well as in hospitals.
There are additional sites that use mobile focused ultrasound equipment. These sites may not be listed on the EDAP, Sonablate, or Profound Medical sites, and the best way to find them is to contact local urologists to see if they have focused ultrasound capability.
Reimbursement for primary treatment in the US has been lagging, and Medicare and most insurance companies are either covering a portion of the expense or not covering it at all. In the specific instance of salvage therapy after failed radiation, some Medicare providers and commercial insurance carriers are covering focused ultrasound use in this setting. As always, it is best to check with your specific carrier.
Suggested Reading: Focused Ultrasound for Prostate Cancer Case Study (2021)
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