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 multi-site clinical trial in the US, Canada and Finland is completing a randomized trial comparing the TULSA PRO to radical prostatectomy.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
See a list of treatment 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)
Rischmann P, Occéan BV, Ploussard G. Reply to Jason Koehler and Abhinav Sidana’s Letter to the Editor re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2024.11.006. Eur Urol. 2025 Feb 6:S0302-2838(25)00062-4. doi: 10.1016/j.eururo.2025.01.022. PMID: 39920006
Bochner E, Schulte V, Lotan Y, Meng X, Costa DN. Feasibility and Short-Term Safety of Hydrogel Spacer before Treatment with Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation for Prostate Cancer Treatment. J Endourol. 2025 Feb 10. doi: 10.1089/end.2024.0700. PMID: 39925110
Montorsi F, Gandaglia G, Stabile A. Re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. Eur Urol. 2025 Feb 15:S0302-2838(25)00063-6. doi: 10.1016/j.eururo.2025.01.023. PMID: 39956725
Hsieh PF, Naruse J, Yuzuriha S, Umemoto T, Huang CP, Shoji S. Combining Percentage Prostate-Specific Antigen Reduction and Multiparametric Magnetic Resonance Imaging to Reduce Unnecessary Biopsy After Focal Therapy With High-Intensity Focused Ultrasound for Prostate Cancer. Int J Urol. 2025 Feb 19. doi: 10.1111/iju.70013. PMID: 39968685
Matsuoka Y. Editorial Comment to “Combining Percentage Prostate-Specific Antigen Reduction and Multiparametric Magnetic Resonance Imaging to Reduce Unnecessary Biopsy After Focal Therapy With High-Intensity Focused Ultrasound for Prostate Cancer“. Int J Urol. 2025 Feb 27. doi: 10.1111/iju.70031. PMID: 40012537
Muhler P, Akuamoa-Boateng D, Rosenbrock J, Stock S, Müller D, Heidenreich A, Simões Corrêa Galendi J. Cost-utility analysis of MR imaging-guided transurethral ultrasound ablation for the treatment of low- to intermediate-risk localised prostate cancer. BMJ Open. 2025 Jan 11;15(1):e088495. doi: 10.1136/bmjopen-2024-088495. PMID: 39800402
Teoh JY, Wong CH. When precision meets prostate cancer: the rising role of HIFU focal therapy. Prostate Cancer Prostatic Dis. 2025 Jan 20. doi: 10.1038/s41391-025-00940-5. PMID: 39833291
Su S, Wang Y, Lo EM, Tamukong P, Kim HL. High-intensity focused ultrasound ablation to increase tumor-specific lymphocytes in prostate cancer. Transl Oncol. 2025 Jan 24;53:102293. doi: 10.1016/j.tranon.2025.102293. PMID: 39862483
Koehler J, Sidana A. Re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2024.11.006. Eur Urol. 2025 Jan 24:S0302-2838(25)00021-1. doi: 10.1016/j.eururo.2024.12.021. PMID: 39863507
Koehler J, Lazarovich A, Tayebi S, Viswanath V, George A, Hsu WW, Sidana A. Shifting tides: A survey analysis of urologists’ evolving attitudes toward focal therapy for prostate cancer. Indian J Urol. 2025;41(1):59-65. doi: 10.4103/iju.iju_239_24. Epub 2025 Jan 1. PMID: 39886635
Delgado J, Porto JG, Bhatia A, Raymo A, Blachman-Braun R, Ajami T, Rathinam A, Freitas PFS, Khandekar A, Marcovich R, Parekh DJ, Nahar B, Shah HN. Functional outcomes of single-session holmium laser enucleation of the prostate and high-intensity focused ultrasound in management of patients with prostate cancer and enlarged prostate: results from a pilot study. World J Urol. 2024 Dec 30;43(1):53. doi: 10.1007/s00345-024-05424-0. PMID: 39739024
Lee HS, Song SH, Lee H, Hong SK. Whole gland versus partial gland ablation in patients with localized prostate cancer treated by high-intensity focused ultrasound ablation. Prostate Int. 2024 Dec;12(4):213-218. doi: 10.1016/j.prnil.2024.09.001. Epub 2024 Sep 5. PMID: 39735197
Yang CH, Barbulescu DV, Marian L, Tung MC, Ou YC, Wu CH. High-Intensity Focus Ultrasound Ablation in Prostate Cancer: A Systematic Review. J Pers Med. 2024 Dec 20;14(12):1163. doi: 10.3390/jpm14121163. PMID: 39728075
Anttinen M, Mäkelä P, Nurminen P, Pärssinen H, Malaspina S, Sainio T, Högerman M, Taimen P, Blanco Sequeiros R, Boström PJ. Salvage Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation for Localized Radiorecurrent Prostate Cancer. Eur Urol Open Sci. 2024 Dec 5;71:69-77. doi: 10.1016/j.euros.2024.11.001. eCollection 2025 Jan. PMID: 39703741
Click here for additional references from PubMed.
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