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 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
Outside Approval SquareFocused 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.

Clinical Trials SquareClinical 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.

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. Find a center near you >

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.

Notable Papers

Lalla VD, Elakshar S, Anidjar M, Bahoric B, McPherson V, Ferrario C, Probst S, Niazi TM. Salvage External Beam Radiotherapy After HIFU Failure in Localized Prostate Cancer: A Single Institution Experience. Int J Radiat Oncol Biol Phys. 2021 Nov 1;111(3S):e272-e273. doi: 10.1016/j.ijrobp.2021.07.884.

Chirila ME, Brausi M, Chatterjee P, Gordon K, Kacso G, Kettache RH, Li B, Ma WK, Martinez DA, Mazibuko T, Murgic J, Patel HR, de Reijke TM, Riedl C, Turner S, Zilli T, Poortmans P, Roach M 3rd. Salvage Treatments for the Local Recurrence of Prostate Cancer After Radiotherapy - Results of an International Multidisciplinary Survey. Int J Radiat Oncol Biol Phys. 2021 Nov 1;111(3S):e268. doi: 10.1016/j.ijrobp.2021.07.874.

Schaudinn A, Michaelis J, Franz T, Ho-Thi P, Horn LC, Blana A, Hadaschik B, Stumpp P, Stolzenburg JU, Schlemmer HP, Denecke T, Busse H, Ganzer R, Linder N. High-intensity focused ultrasound (HIFU) hemiablation of the prostate: Late follow-up MRI findings in non-recurrent patients. Eur J Radiol. 2021 Sep 17;144:109957. doi: 10.1016/j.ejrad.2021.109957.

Marsden T, Lomas DJ, McCartan N, Hadley J, Tuck S, Brown L, Haire A, Moss CL, Green S, Van Hemelrijck M, Coolen T, Santaolalla A, Isaac E, Brembilla G, Kopcke D, Giganti F, Sidhu H, Punwani S, Emberton M, Moore CM; ReIMAGINE Study Group. ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI. BMJ Open. 2021 Sep 30;11(9):e048144. doi: 10.1136/bmjopen-2020-048144.

Parras O, Domínguez P, Tomás-Biosca A, Guridi J. The role of tractography in the localisation of the Vim nucleus of the thalamus and the dentatorubrothalamic tract for the treatment of tremor. Neurologia (Engl Ed). 2021 Sep 23:S2173-5808(21)00142-5. doi: 10.1016/j.nrleng.2019.09.008.

Abrams LR, Koch MO, Bahler CD. Focal High-Intensity Focused Ultrasound Ablation of the Prostate. J Endourol. 2021 Sep;35(S2):S24-S32. doi: 10.1089/end.2020.1161.

Shoji S, Uchida T, Hanada I, Takahashi K, Yuzuriha S, Kano T, Ogawa T, Umemoto T, Kawakami M, Nitta M, Hashida K, Hasegawa M, Hasebe T, Miyajima A. Analysis of oncological outcomes of whole-gland therapy with high-intensity focused ultrasound for localized prostate cancer in clinical and technical aspects: a retrospective consecutive case-series analysis with a median 5-year follow-up. Int J Hyperthermia. 2021;38(1):1205-1216. doi: 10.1080/02656736.2021.1945150.

Rompré-Brodeur A, Marcq G, Tholomier C, Fugaru I, Loutochin O, Anidjar M, Bladou F. Role of Systematic Control Biopsies Following Partial Gland Ablation with High-Intensity Focused Ultrasound for Clinically Significant Prostate Cancer. J Urol. 2021 Jul 12:101097JU0000000000001934. doi: 10.1097/JU.0000000000001934.

Spitznagel T, Hardenberg JV, Schmid FA, Rupp NJ, Westhoff N, Worst TS, Weis CA, Mortezavi A, Eberli D. Salvage robotic-assisted laparoscopic radical prostatectomy following focal high-intensity focused ultrasound for ISUP 2/3 cancer. Urology. 2021 Jun 26:S0090-4295(21)00569-0. doi: 10.1016/j.urology.2021.04.059.

Shi R, Chong KT, Tan PH. Histopathological features of recurrent prostate adenocarcinoma after high intensity focused ultrasound (HIFU) focal treatment: A case report. Urol Case Rep. 2021 Jun 6;38:101744. doi: 10.1016/j.eucr.2021.101744. eCollection 2021 Sep.

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 May;17(5):427-433. doi: 10.1080/17434440.2020.1755258.

Rakauskas A, Shah TT, Peters M, Randeva JS, Hosking-Jervis F, Schmainda MJ, Orczyck C, Emberton M, Arya M, Moore C, Ahmed HU. Can quantitative analysis of multi-parametric MRI independently predict failure of focal salvage HIFU therapy in men with radio-recurrent prostate cancer? Urol Oncol. 2021 May 25:S1078-1439(21)00176-9. doi: 10.1016/j.urolonc.2021.04.017.

Checcucci E, De Luca S, Piramide F, Garrou D, Mosca A, Galla A, Belli G, Russo F, Rescigno P, Poti C, Amparore D, Verri P, Volpi G, Manfredi M, Fiori C, Porpiglia F. The real-time intraoperative guidance of the new HIFU Focal-One() platform allows to minimize the perioperative adverse events in salvage setting. J Ultrasound. 2021 May 24. doi: 10.1007/s40477-021-00594-8.

Lopez W, Nguyen N, Cao J, Eddow C, Shung KK, Lee NS, Chow MSS. Ultrasound Therapy, Chemotherapy and Their Combination for Prostate Cancer. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211011965. doi: 10.1177/15330338211011965.

Dellabella M, Branchi A, Di Rosa M, Pucci M, Gasparri L, Claudini R, Carnevali F, Cecchini S, Castellani D. Oncological and functional outcome after partial prostate HIFU ablation with Focal-One(): a prospective single-center study. Prostate Cancer Prostatic Dis. 2021 May 18. doi: 10.1038/s41391-021-00390-9.

Magee D, Perlis N, Corr K, Chan R, Gertner M, Zisman A, Jokhu S, Ghai S. Salvage interstitial laser thermal therapy under MRI guidance (MRgFLA) for high-intensity focal ultrasound (HIFU) recurrences: feasibility study. Clin Imaging. 2021 Apr 28;76:217-221. doi: 10.1016/j.clinimag.2021.04.014.

van Son MJ, Peters M, Reddy D, Shah TT, Hosking-Jervis F, Robinson S, Lagendijk JJW, Mangar S, Dudderidge T, McCracken S, Hindley RG, Emara A, Nigam R, Persad R, Virdi J, Lewi H, Moore C, Orczyk C, Emberton M, Arya M, Ahmed HU, van der Voort van Zyp JRN, Winkler M, Falconer A. Conventional radical versus focal treatment for localised prostate cancer: a propensity score weighted comparison of 6-year tumour control. Prostate Cancer Prostatic Dis. 2021 May 1. doi: 10.1038/s41391-021-00369-6.

Click here for additional references from PubMed.

Video courtesy of SonaCare Medical

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