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.
Advantages
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-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
Suggested Reading: Focused Ultrasound for Prostate Cancer Case Study (2021)
Duan H, Ghanouni P, Daniel B, Rosenberg J, Davidzon GA, Aparici CM, Kunder C, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Evaluation of Prostate Cancer Response to High-Intensity Focused Ultrasound Therapy. J Nucl Med. 2023 Apr;64(4):592-597. doi: 10.2967/jnumed.122.264783. Epub 2022 Nov 3.
Sonn G, Khandwala Y. Reply to Carmen Gravina, Riccardo Lombardo, and Cosimo De Nunzio’s Letter to the Editor re: Yash S. Khandwala, Simon John Christoph Soerensen, Shravan Morisetty, et al. The Association of Tissue Change and Treatment Success During High-intensity Focused Ultrasound Focal Therapy for Prostate Cancer. Eur Urol Focus. In press. Eur Urol Focus. 2023 Apr 1:S2405-4569(23)00087-1. doi: 10.1016/j.euf.2023.03.019.
Habashy D, Reddy D, Peters M, Shah TT, van Son M, van Rossum P, Tanaka MB, Cullen E, Engle R, McCracken S, Greene D, Hindley RG, Emara A, Nigam R, Orczyk C, Shergill I, Persad R, Virdi J, Moore CM, Arya M, Winkler M, Emberton M, Ahmed HU, Dudderidge T. Evaluation of Outcomes Following Focal Ablative Therapy for Treatment of Localized Clinically Significant Prostate Cancer in Patients >70 Years: A Multi-institute, Multi-energy 15-Year Experience. J Urol. 2023 Apr 4:101097JU0000000000003443. doi: 10.1097/JU.0000000000003443.
Meyer L, Bohlscheid A, Lemmer O, van de Plas J, Leboutte F, Hadaschik BA, Neisius A, Willinek WA. MR-Guided Transurethral Ultrasound Ablation of Prostate Cancer: Initial Experience of Monitoring Tumor Response by Dynamic Apparent Diffusion Coefficient Measurements at 3.0 T. Urol Int. 2023 Apr 18:1-9. doi: 10.1159/000529873.
Ghoreifi A, Kaneko M, Peretsman S, Iwata A, Brooks J, Shakir A, Sugano D, Cai J, Cacciamani G, Park D, Lebastchi AH, Ukimura O, Bahn D, Gill I, Abreu AL. Patient-reported Satisfaction and Regret Following Focal Therapy for Prostate Cancer: A Prospective Multicenter Evaluation. Eur Urol Open Sci. 2023 Feb 18;50:10-16. doi: 10.1016/j.euros.2023.02.003. eCollection 2023 Apr.
Mäkelä P, Wright C, Anttinen M, Boström PJ, Blanco Sequeiros R. Safety and efficacy of MRI-guided transurethral ultrasound ablation for radiorecurrent prostate cancer in the presence of gold fiducial markers. Acta Radiol. 2023 Mar;64(3):1228-1237. doi: 10.1177/02841851221108292. Epub 2022 Jun 24.
Ghai S, Perlis N. Beyond the AJR: MRI-Guided Focused Ultrasound Focal Therapy for Intermediate-Risk Prostate Cancer. AJR Am J Roentgenol. 2023 Apr;220(4):610. doi: 10.2214/AJR.22.28413. Epub 2022 Aug 24.
Westhoff N, Ernst R, Kowalewski KF, Derigs F, Neuberger M, Nörenberg D, Popovic ZV, Ritter M, Stephan Michel M, von Hardenberg J. Medium-term Oncological Efficacy and Patient-reported Outcomes After Focal High-intensity Focused Ultrasound: The FOXPRO Trial. Eur Urol Focus. 2023 Mar;9(2):283-290. doi: 10.1016/j.euf.2022.10.006. Epub 2022 Nov 4.
Duwe G, Boehm K, Haack M, Sparwasser P, Brandt MP, Mager R, Tsaur I, Haferkamp A, Höfner T. Single-center, prospective phase 2 trial of high-intensity focused ultrasound (HIFU) in patients with unilateral localized prostate cancer: good functional results but oncologically not as safe as expected. World J Urol. 2023 Mar 15. doi: 10.1007/s00345-023-04352-9.
Koelker M, Labban M, Frego N, Meyer CP, Salomon G, Lipsitz SR, Withington J, Moore CM, Tempany CM, Tuncali K, George A, Kibel AS, Trinh QD, Cole AP. Contemporary patterns of local ablative therapies for prostate cancer at United States cancer centers: results from a national registry. World J Urol. 2023 Mar 17. doi: 10.1007/s00345-023-04354-7.
Gravina C, Lombardo R, De Nunzio C. Re: Yash S. Khandwala, Simon John Christoph Soerensen, Shravan Morisetty, et al. The Association of Tissue Change and Treatment Success During High-intensity Focused Ultrasound Focal Therapy for Prostate Cancer. Eur Urol Focus. In press. Eur Urol Focus. 2023 Mar 31:S2405-4569(23)00088-3. doi: 10.1016/j.euf.2023.02.012.
Cribbs KA, Manning EF, Zhou J, Lahue BJ, Polascik TJ. Real-World Comparative Safety and Effectiveness of Irreversible Electroporation and High-Intensity Focused Ultrasound for Prostate Cancer Ablation. Urology. 2023 Feb 1:S0090-4295(23)00071-7. doi: 10.1016/j.urology.2023.01.024.
Zhang X, Greiser S, Roy U, Lange F, van Gorkum R, Fournelle M, Speicher D, Tretbar S, Melzer A, Landgraf L. Evaluation of a Developed MRI-Guided Focused Ultrasound System in 7 T Small Animal MRI and Proof-of-Concept in a Prostate Cancer Xenograft Model to Improve Radiation Therapy. Cells. 2023 Feb 2;12(3):481. doi: 10.3390/cells12030481.
Rabinowitz MJ, Haney NM, Myers AA, Dora CD, Pavlovich CP. Urinary Outcomes After Magnetic Resonance Imaging-Guided Whole-Gland Transurethral Ultrasound Ablation for Prostate Cancer: Comparison of Suprapubic Tube to Indwelling Urethral Catheter. J Endourol. 2023 Jan;37(1):1-7. doi: 10.1089/end.2022.0214. Epub 2022 Sep 26.
Dai J, Wu Y, Chen Z, Xiao L, Zhang W, Cao Y. Sonosensitive Phase-Changeable Nanoparticle Mediated Enhanced Chemotherapy in Prostate Cancer by Low-Intensity Focused Ultrasound. Int J Mol Sci. 2023 Jan 3;24(1):825. doi: 10.3390/ijms24010825.
Alabousi M, Ghai S. Magnetic resonance imaging-guided ultrasound ablation for prostate cancer – A contemporary review of performance. Front Oncol. 2023 Jan 4;12:1069518. doi: 10.3389/fonc.2022.1069518. eCollection 2022.
Wright C, Mäkelä P, Bigot A, Anttinen M, Boström PJ, Blanco Sequeiros R. Deep learning prediction of non-perfused volume without contrast agents during prostate ablation therapy. Biomed Eng Lett. 2022 Nov 8;13(1):31-40. doi: 10.1007/s13534-022-00250-y. eCollection 2023 Feb.
Dias N, Rodriguez-Sanchez L, Colandrea G, Macek P, Cathelineau X. Medium-term oncological outcomes of intermediate-risk prostate cancer treated with HIFU or cryotherapy. A single center 10-year experience. Arch Ital Urol Androl. 2022 Dec 27;94(4):413-419. doi: 10.4081/aiua.2022.4.413.
Marra G, Soeterik T, Oreggia D, Tourinho-Barbosa R, Moschini M, Stabile A, Filippini C, van Melick HH, van den Bergh RC, Gontero P, Pasquali C, Macek P, Cathala N, Sanchez-Salas R, Cathelineau X. Focal High-Intensity Focused Ultrasound vs. Active Surveillance for ISUP Grade 1 Prostate Cancer: Medium-Term Results of a Matched-Pair Comparison. Clin Genitourin Cancer. 2022 Dec;20(6):592-604. doi: 10.1016/j.clgc.2022.06.009. Epub 2022 Jun 30.
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 Dec;170:161-167. doi: 10.1016/j.urology.2022.07.024. Epub 2022 Jul 28.
Hall WA, Shoag J, Spratt DE. Re: MRI-guided Focused Ultrasound Focal Therapy for Patients with Intermediate-risk Prostate Cancer: A Phase 2b, Multicentre Study. Eur Urol. 2022 Dec;82(6):661-662. doi: 10.1016/j.eururo.2022.08.027. Epub 2022 Sep 30.
Zhong J, Brown S, Serra M, Shuttleworth P, Bownes P, Thompson C, Reed R, Reeves K, Dubec M, McHugh D, Eccles C, Chuter R, Tsang YM, Taylor NJ, West C, Buckley D, Scarsbrook A, Choudhury A, Hoskin P, Henry A. Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT). BMJ Open. 2022 Nov 8;12(11):e068580. doi: 10.1136/bmjopen-2022-068580.
Shoji S, Kuroda S, Uemura K, Oda K, Kano T, Ogawa T, Umemoto T, Nakano M, Kawakami M, Nitta M, Hasegawa M, Miyajima A. Risk Factors for Severe Erectile Dysfunction after Focal Therapy with High-Intensity Focused Ultrasound for Prostate Cancer. Biomedicines. 2022 Nov 10;10(11):2876. doi: 10.3390/biomedicines10112876.
Khandwala YS, Soerensen SJC, Morisetty S, Ghanouni P, Fan RE, Vesal S, Rusu M, Sonn GA. The Association of Tissue Change and Treatment Success During High-intensity Focused Ultrasound Focal Therapy for Prostate Cancer. Eur Urol Focus. 2022 Nov 10:S2405-4569(22)00237-1. doi: 10.1016/j.euf.2022.10.010.
Di Lalla V, Elakshar S, Anidjar M, Tolba M, Hassan T, Bahoric B, McPherson V, Probst S, Niazi T. Salvage external beam radiotherapy after HIFU failure in localized prostate cancer: A single institution experience. Front Oncol. 2022 Nov 3;12:1028858. doi: 10.3389/fonc.2022.1028858. eCollection 2022.
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.
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.
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
