FDA Approved square

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.

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 three focused ultrasound manufacturers that are approved in the US for the ablation (destruction) of prostate tissue – SonaCare Medical,  EDAP-TMS, and Profound Medical. Some of these systems deliver care outside of the MRI facility, so they are found in surgery centers and surgical suites, as well as in hospitals. 

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 additional sites that use mobile focused ultrasound equipment. These sites may not be listed on the EDAP, SonaCare, 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.

Notable Papers

Shoji S, Hiraiwa S, Uemura K, Nitta M, Hasegawa M, Kawamura Y, Hashida K, Hasebe T, Tajiri T, Miyajima A. Focal therapy with high-intensity focused ultrasound for the localized prostate cancer for Asian based on the localization with MRI-TRUS fusion image-guided transperineal biopsy and 12-cores transperineal systematic biopsy: prospective analysis of oncological and functional outcomes. Int J Clin Oncol. 2020 Jun 17. doi: 10.1007/s10147-020-01723-9.

Maoui M, Gonindard-Melodelima C, Chapet O, Colombel M, Ruffion A, Crouzet S, Rouvière O. Candidates to salvage therapy after external-beam radiotherapy of prostate cancer: Predictors of local recurrence volume and metastasis-free survival. Diagn Interv Imaging. 2020 Jun 10:S2211-5684(20)30153-4. doi: 10.1016/j.diii.2020.05.007.

Westhoff N, Ernst R, Kowalewski KF, Schmidt L, Worst TS, Michel MS, von Hardenberg. Treatment decision satisfaction and regret after focal HIFU for localized prostate cancer. J.World J Urol. 2020 Jun 12. doi: 10.1007/s00345-020-03301-0.

Bacchetta F, Martins M, Regusci S, Jichlinski P, Meuwly JY, Lucca I, Valerio M. The Utility of intraoperative contrast-enhanced ultrasound in detecting residual disease after focal HIFU for localized prostate cancer. Urol Oncol. 2020 Jun 9:S1078-1439(20)30215-5. doi: 10.1016/j.urolonc.2020.05.010.

Ghafoor S, Becker AS, Stocker D, Barth BK, Eberli D, Donati OF, Vargas HA. Magnetic resonance imaging of the prostate after focal therapy with high intensity focused ultrasound. Abdom Radiol (NY). 2020 May 23. doi: 10.1007/s00261-020-02577-5.

Stabile A, Orczyk C, Giganti F, Moschini M, Allen C, Punwani S, Cathala N, Ahmed HU, Cathelineau X, Montorsi F, Emberton M, Briganti A, Sanchez-Salas R, Moore CM. The Role of Percentage of Prostate-specific Antigen Reduction After Focal Therapy Using High-intensity Focused Ultrasound for Primary Localised Prostate Cancer. Results from a Large Multi-institutional Series. Eur Urol. 2020 May 19:S0302-2838(20)30336-5. doi: 10.1016/j.eururo.2020.04.068.

Reddy D, Shah TT, Dudderidge T, McCracken S, Arya M, Dobbs C, Emberton M, Fiorentino F, Day E, Prevost AT, Staffurth J, Sydes M, Winkler M, Ahmed HU. Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial. Contemp Clin Trials. 2020 Apr 14:105999. doi: 10.1016/j.cct.2020.105999.

Napoli A, Alfieri G, Scipione R, Leonardi A, Fierro D, Panebianco V, De Nunzio C, Leonardo C, Catalano C. High-intensity focused ultrasound for prostate cancer. Expert Rev Med Devices. 2020 Apr 10. doi: 10.1080/17434440.2020.1755258.

Ahmed HU, Huber P, Afzal N, Arya M, Boxler S, Dudderidge T, Emberton M, Guillaumier S, Hindley RG, Hosking-Jervis F, Leeman L, Lewi H, McCartan N, Moore C, Nigam AK, Ogden C, Persad R, Thalmann G, Virdi J, Winkler M. An exploratory study of dose escalation versus standard focal High Intensity Focused Ultrasound for treating non-metastatic prostate cancer. J Endourol. 2020 Apr 7. doi: 10.1089/end.2019.0613.

Guo X, Zhu H, Zhou K, Chengbing J, Yang Y, Zhang J, Yang W, Ran L, Dimitrov D. Effects of high-intensiry focused ultrasound treatment on peripancreatic arterial and venous blood vessels in pancreatic cancer. April 3, 2020.

Nahar B, Bhat A, Reis IM, Soodana-Prakash N, Becerra MF, Lopategui D, Venkatramani V, Patel R, Madhusoodanan V, Kryvenko ON, Ritch CR, Gonzalgo ML, Punnen S, Parekh DJ. Prospective Evaluation of Focal High-Intensity Focused Ultrasound (HIFU) for Patients with Localized Prostate Cancer. J Urol. 2020 Mar 13:101097JU0000000000001015. doi: 10.1097/JU.0000000000001015.

Rigo M, Mazzola R, Napoli G, Giaj-Levra N, Figlia V, Nicosia L, Ricchetti F, Tomasini D, Bonù ML, Cuccia F, Bellorofonte C, Alongi F. Post-HIFU locally relapsed prostate cancer: high-dose salvage radiotherapy guided by molecular imaging. Radiol Med. 2020 Feb 19. doi: 10.1007/s11547-020-01148-4.

Connor MJ, Gorin MA, Ahmed HU, Nigam R. Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI. Prostate Cancer Prostatic Dis. 2020 Feb 12. doi: 10.1038/s41391-020-0206-6. Review.

Lovegrove CE, Peters M, Guillaumier S, Arya M, Afzal N, Dudderidge T, Hosking-Jervis F, Hindley RJ, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Virdi J, Winkler M, Emberton M, Ahmed HU, Shah TT, Minhas S. Evaluation of functional outcomes after a second focal high-intensity focused ultrasonography (HIFU) procedure in men with primary localized, non-metastatic prostate cancer: results from the HIFU Evaluation and Assessment of Treatment (HEAT) registry. BJU Int. 2020 Jan 23. doi: 10.1111/bju.15004.

Huber PM, Afzal N, Arya M, Boxler S, Dudderidge T, Emberton M, Guillaumier S, Hindley RG, Hosking-Jervis F, Leemann L, Lewi H, McCartan N, Moore CM, Nigam R, Odgen C, Persad R, Thalmann GN, Virdi J, Winkler M, Ahmed HU. Prostate Specific Antigen Criteria to Diagnose Failure of Cancer Control following Focal Therapy of Nonmetastatic Prostate Cancer Using High Intensity Focused Ultrasound. J Urol. 2020 Jan 13:101097JU0000000000000747. doi:10.1097/JU.0000000000000747.

Dosanjh A, Harvey P, Baldwin S, Mintz H, Evison F, Gallier S, Trudgill N, James ND, Sooriakumaran P, Patel P. High-intensity Focused Ultrasound for the Treatment of Prostate Cancer: A National Cohort Study Focusing on the Development of Stricture and Fistulae. Eur Urol Focus. 2020 Jan 7. pii: S2405-4569(19)30355-4. doi: 10.1016/j.euf.2019.11.014.

Herrera-Caceres JO, Nason GJ, Salgado-Sanmamed N, Goldberg H, Woon DTS, Chandrasekar T, Ajib K, Tan GH, Alhunaidi O, van der Kwast T, Finelli A, Zlotta AR, Hamilton RJ, Berlin A, Perlis N, Fleshner NE. Salvage Prostatectomy Following Focal Therapy- Functional and Oncological outcomes. BJU Int. 2019 Dec 21. doi:10.1111/bju.14976.

Dubinsky TJ, Khokhlova TD, Khokhlova V, Schade GA. Histotripsy: The Next Generation of High-Intensity Focused Ultrasound for Focal Prostate Cancer Therapy. J Ultrasound Med. 2019 Dec 12. doi: 10.1002/jum.15191. Review.

Shoji S, Hiraiwa S, Ogawa T, Hanada I, Nakano M, Zakoji H, Hashida K, Matsumoto T, Hasebe T, Tajiri T, Uchida T, Miyajima A. [FOCAL THERAPY WITH HIGH-INTENSITY FOCUSED ULTRASOUND FOR THE LOCALIZED PROSTATE CANCER BASED ON THE LOCALIZATION WITH MRI-TRUS FUSION IMAGE-GUIDED BIOPSY: 1-YEAR PROSPECTIVE STUDY]. Nihon Hinyokika Gakkai Zasshi. 2018;109(4):194-203. doi: 10.5980/jpnjurol.109.194. Japanese.

Schmid FA, Schindele D, Mortezavi A, Spitznagel T, Sulser T, Schostak M, Eberli D. Prospective multicentre study using high intensity focused ultrasound (HIFU) for the focal treatment of prostate cancer: Safety outcomes and complications. Urol Oncol. 2019 Oct 15. pii: S1078-1439(19)30352-7. doi: 10.1016/j.urolonc.2019.09.001.

Claros OR, Tourinho-Barbosa RR, Carneiro A, Collura-Merlier S, Macek P, Lanz C, Cathala N, Prapotnich D, Mombet A, Sanchez-Salas R, Cathelineau X. HIFU focal therapy for prostate cancer using intraoperatory contrast enhanced ultrasound. Arch Esp Urol. 2019 Oct;72(8):825-830.

Rosenhammer B, Ganzer R, Zeman F, Näger T, Fritsche HM, Blana A, Burger M, Bründl J. Oncological long-term outcome of whole gland HIFU and open radical prostatectomy: a comparative analysis. World J Urol. 2019 Oct;37(10):2073-2080. doi: 10.1007/s00345-018-2613-z. Epub 2019 Jan 2.

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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