Prostate Cancer 

Last Updated:

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.

Clinical Trials

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.

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. 

There are four focused ultrasound manufacturers that are approved in the US for the ablation (destruction) of prostate tissue – Sonablate Corp.,  EDAP-TMSProfound 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 

Suggested Reading: Focused Ultrasound for Prostate Cancer Case Study (2021)

Khokhlova VA, Rosnitskiy PB, Tsysar SA, Buravkov SV, Ponomarchuk EM, Sapozhnikov OA, Karzova MM, Khokhlova TD, Maxwell AD, Wang YN, Kadrev AV, Chernyaev AL, Chernikov VP, Okhobotov DA, Kamalov AA, Schade GR. Initial Assessment of Boiling Histotripsy for Mechanical Ablation of Ex Vivo Human Prostate Tissue. Ultrasound Med Biol. 2022 Oct 4:S0301-5629(22)00507-5. doi: 10.1016/j.ultrasmedbio.2022.07.014.

Miura M, Takahashi S, Fukumoto M, Higashiyama H. Initial experience of transurethral ultrasound ablation of the prostate in Asia. BJUI Compass. 2022 Jun 23;3(6):405-407. doi: 10.1002/bco2.175. eCollection 2022 Nov.

DE Luca S, Checcucci E, Piramide F, Russo F, Alessio P, Garrou D, Peretti D, Sica M, Volpi G, Piana A, DE Cillis S, Amparore D, Manfredi M, Fiori C, Porpiglia F. MRI/real-time ultrasound image fusion guided high-intensity focused ultrasound (HIFU): a prospective comparative and functional analysis of different ablative techniques. Minerva Urol Nephrol. 2022 Oct 26. doi: 10.23736/S2724-6051.22.04853-4.

Pan Y, Wang S, Liu L, Liu X. Whole-gland high-intensity focused ultrasound ablation and transurethral resection of the prostate in the patients with prostate cancer: A systematic review and meta-analysis. Front Oncol. 2022 Oct 12;12:988490. doi: 10.3389/fonc.2022.988490. eCollection 2022.

Mesci A, Gouran-Savadkoohi M, Ribeiro D, Dayes I, Lukka H, Schnarr K, Quan K, Goldberg M, Hallock A, Tsakiridis T. Salvage radiotherapy following HiFU: An institutional series and literature review. J Med Imaging Radiat Oncol. 2022 Sep;66(6):847-852. doi: 10.1111/1754-9485.13384. Epub 2022 Feb 16.

Barham DW, Barnard J, Gelman J. Urethral Stricture/Stenosis as a Complication of High Intensity Focused Ultrasound of the Prostate (HIFU): What is the Overall Patient Experience? Urology. 2022 Sep;167:211-217. doi: 10.1016/j.urology.2022.04.041. Epub 2022 Jun 6.

Khandwala YS, Morisetty S, Ghanouni P, Fan RE, Soerensen SJC, Rusu M, Sonn GA. Evaluation of post-ablation mpMRI as a predictor of residual prostate cancer after focal high intensity focused ultrasound (HIFU) ablation. Urol Oncol. 2022 Sep 1:S1078-1439(22)00277-0. doi: 10.1016/j.urolonc.2022.07.017.

Karwacki J, Kiełbik A, Szlasa W, Sauer N, Kowalczyk K, Krajewski W, Saczko J, Kulbacka J, Szydełko T, Małkiewicz B. Boosting the Immune Response-Combining Local and Immune Therapy for Prostate Cancer Treatment. Cells. 2022 Sep 7;11(18):2793. doi: 10.3390/cells11182793.

Rabinowitz MJ, Haney NM, Myers AA, Dora C, Pavlovich C. Urinary Outcomes after Magnetic Resonance Imaging-Guided Whole Gland Transurethral Ultrasound Ablation (TULSA) for Prostate Cancer: Comparison of Suprapubic Tube to Indwelling Urethral Catheter. J Endourol. 2022 Aug 26. doi: 10.1089/end.2022.0214.

Ghai S, Perlis N. Beyond the AJR: MRI-Guided Focused Ultrasound Focal Therapy for Intermediate-Risk Prostate Cancer. AJR Am J Roentgenol. 2022 Aug 24. doi: 10.2214/AJR.22.28413.

Fujihara A, Ukimura O. Focal therapy of localized prostate cancer. Int J Urol. 2022 Aug 22. doi: 10.1111/iju.14991.

Montorsi F, Stabile A, Mazzone E, Gandaglia G, Briganti A. Re: Deepika Reddy, Max Peters, Taimur T. Shah, et al. Cancer Control Outcomes Following Focal Therapy Using High-intensity Focused Ultrasound in 1379 Men with Nonmetastatic Prostate Cancer: A Multi-institute 15-year Experience. Eur Urol 2022;81:407-13. Eur Urol. 2022 Sep;82(3):e73. doi: 10.1016/j.eururo.2022.05.020. Epub 2022 Jun 2.

Martini A, Ploussard G. Re: Cancer Control Outcomes Following Focal Therapy Using High-intensity Focused Ultrasound in 1379 Men with Nonmetastatic Prostate Cancer: A Multi-institute 15-year Experience. Eur Urol. 2022 Aug;82(2):241. doi: 10.1016/j.eururo.2022.03.020. Epub 2022 Mar 25.

Reddy D, Ahmed HU. Reply to Francesco Montorsi, Armando Stabile, Elio Mazzone, Giorgio Gandaglia, and Alberto Briganti’s Letter to the Editor re: Deepika Reddy, Max Peters, Taimur T. Shah, et al. Cancer Control Outcomes Following Focal Therapy Using High-intensity Focused Ultrasound in 1379 Men with Nonmetastatic Prostate Cancer: A Multi-institute 15-year Experience. Eur Urol 2022;81:407-13. Eur Urol. 2022 Sep;82(3):e74-e75. doi: 10.1016/j.eururo.2022.05.035. Epub 2022 Jun 8.

Qaoud Y, Herrera-Caceres JO, Bass R, Berjaoui MB, Tiwari R, Kenk M, Lajkosz K, Finelli A, Perlis N, Klotz L, Fleshner N. Salvage partial gland ablation for recurrent prostate cancer following primary partial gland ablation: Functional and oncological outcomes. Urol Oncol. 2022 Jul;40(7):343.e1-343.e6. doi: 10.1016/j.urolonc.2022.03.019. Epub 2022 May 9.

Flegar L, Zacharis A, Aksoy C, Heers H, Derigs M, Eisenmenger N, Borkowetz A, Groeben C, Huber J. Alternative- and focal therapy trends for prostate cancer: a total population analysis of in-patient treatments in Germany from 2006 to 2019. World J Urol. 2022 Jul;40(7):1645-1652. doi: 10.1007/s00345-022-04024-0. Epub 2022 May 13.

Ehdaie B, Tempany CM, Holland F, Sjoberg DD, Kibel AS, Trinh QD, Durack JC, Akin O, Vickers AJ, Scardino PT, Sperling D, Wong JYC, Yuh B, Woodrum DA, Mynderse LA, Raman SS, Pantuck AJ, Schiffman MH, McClure TD, Sonn GA, Ghanouni P. MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: a phase 2b, multicentre study. Lancet Oncol. 2022 Jul;23(7):910-918. doi: 10.1016/S1470-2045(22)00251-0. Epub 2022 Jun 14.

Kuroki T, Shoji S, Uchida T, Akiba T, Kabuki S, Nagao R, Fukuzawa T, Matsumoto Y, Katsumata T, Futakami N, Mikami T, Nakano Y, Toyoda Y, Takazawa T, Kunieda E, Sugawara A. Comparing the toxicity and disease control rate of radiotherapy for prostate cancer between salvage settings after high-intensity focused ultrasound therapy and initial settings. J Radiat Res. 2022 Jul 19;63(4):675-683. doi: 10.1093/jrr/rrac039.

Nassiri N, Richardson S, Kuppermann D, Brisbane WG, Gonzalez S, Kwan L, Felker E, Wallner C, Marks LS. Partial gland ablation of prostate cancer: Effects of Repeat Treatment. Urology. 2022 Jul 27:S0090-4295(22)00617-3. doi: 10.1016/j.urology.2022.07.024.

Click here for additional references from PubMed.

Video courtesy of SonaCare Medical

FDA Approved
International Approval
Clinical Trials