FDA Approved square

Focused ultrasound treatment for the prostate is available in the United States.

Two focused ultrasound systems for destroying diseased prostate tissue are approved by the Food and Drug Administration. In addition, Medicare has agreed 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.

Outside Approval Square

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.

Advantages:

  • 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.
  • Clinical Trials SquareA 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.

Clinical Trials

There are numerous clinical trials worldwide using focused ultrasound to treat prostate cancer.

See a full list of prostate cancer clinical trials > 

See a list of treatment sites >
See a list of clinical trials sites >
See a list of laboratory research sites >

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 device that is not approved in the US, but is approved in Europe and Oceana.

Notable Papers

Asafu-Adjei D, Mikkilineni N, Sebesta E, Hyams E. Misinformation on the Internet regarding Ablative Therapies for Prostate Cancer. Urology. 2019 Feb 25. pii: S0090-4295(19)30205-5. doi: 10.1016/j.urology.2018.12.050.

Clery R, Grande P, Seisen T, Gobert A, Duquesne I, Villers A, Olivier J, Bernhard JC, Robert G, Beauval JB, Prudhomme T, Bruyère F, Lainé-Caroff P, Waltregny D, Guillonneau B, Panarello D, Ruffion A, De Bayser H, de La Taille A, Roupret M. Outcomes after salvage radical prostatectomy and first-line radiation therapy or HIFU for recurrent localized prostate cancer: results from a multicenter study. World J Urol. 2019 Feb 21. doi: 10.1007/s00345-019-02683-0.

Stabile A, Orczyk C, Hosking-Jervis F, Giganti F, Arya M, Hindley RG, Dickinson L, Allen C, Punwani S, Jameson C, Freeman A, McCartan N, Montorsi F, Briganti A, Ahmed HU, Emberton M, Moore CM. Medium term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using HIFU for primary localized prostate cancer. BJU Int. 2019 Feb 12. doi: 10.1111/bju.14710.

Thompson JE, Sridhar AN, Tan WS, Freeman A, Haider A, Allen C, Moore CM, Orzcyk C, Mazzon G, Khetrapal P, Shaw G, Rajan P, Mohammed A, Briggs TP, Nathan S, Kelly JD, Sooriakumaran P. Pathologic findings and MRI concordance at salvage radical prostatectomy for local recurrence following partial ablation using high-intensity focused ultrasound. J Urol. 2019 Feb 4. doi: 10.1097/JU.0000000000000135.

Loeb S, Sengupta S, Butaney M, Macaluso JN Jr, Czarniecki SW, Robbins R, Braithwaite RS, Gao L, Byrne N, Walter D, Langford A. Dissemination of Misinformative and Biased Information about Prostate Cancer on YouTube. Eur Urol. 2018 Nov 27. pii: S0302-2838(18)30854-6. doi: 10.1016/j.eururo.2018.10.056.

van Son M, Peters M, Moerland M, Kerkmeijer L, Lagendijk J, van der Voort van Zyp J. Focal Salvage Treatment of Radiorecurrent Prostate Cancer: A Narrative Review of Current Strategies and Future Perspectives. Cancers (Basel). 2018 Dec 3;10(12). pii: E480. doi: 10.3390/cancers10120480.

Mathew MS, Oto A. MR Imaging-Guided Focal Therapies of Prostate Cancer. Magn Reson Imaging Clin N Am. 2019 Feb;27(1):131-138. doi: 10.1016/j.mric.2018.08.004. Epub 2018 Oct 29.

Bass EJ, Freeman A, Jameson C, Punwani S, Moore CM, Arya M, Emberton M, Ahmed HU. Prostate cancer diagnostic pathway: Is a one-stop cognitive MRI targeted biopsy service a realistic goal in everyday practice? A pilot cohort in a tertiary referral centre in the UK. BMJ Open. 2018 Oct 24;8(10):e024941. doi: 10.1136/bmjopen-2018-024941.

Hamdy FC, Elliott D, le Conte S, Davies LC, Burns RM, Thomson C, Gray R, Wolstenholme J, Donovan JL, Fitzpatrick R, Verrill C, Gleeson F, Singh S, Rosario D, Catto JW, Brewster S, Dudderidge T, Hindley R, Emara A, Sooriakumaran P, Ahmed HU, Leslie TA. Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT. Health Technol Assess. 2018 Sep;22(52):1-96. doi: 10.3310/hta22520.

Click here for additional references from PubMed.

Video courtesy of SonaCare Medical

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