Prostate Cancer

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.

Benefits

Current treatment options for prostate cancer include surgery, radiation, cryotherapy, hormone therapy, and chemotherapy. These treatment options carry risks and unwanted side effects such as urinary incontinence and erectile dysfunction. Focused ultrasound offers a treatment to patients with prostate cancer that carries fewer risks than conventional therapies. It may also be offered for patients with earlier stage disease where surgery is not yet recommended or as a salvage treatment for patients in which radiation has failed.

Advantages:

Noninvasive – no incisions, no risk of infection or bleeding, less pain, and rapid recovery
Image-guided – precision targeting with minimal damage to surrounding healthy tissue
No ionizing radiation – fewer side effects and can be safely repeated

Regulatory Authorizations

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.

Clinical Trials

The PRISM clinical trial in New York is investigating the rates of recurrence after HIFU treatment.

A second clinical trial in New York is evaluating clinical outcome for patients that have had HIFU treatment.

A clinical trial in Florida is looking at patients quality of life outcomes, with localized radiorecurrent prostate cancer when treated with a the Focal One device.

A clinical trial in California is comparing treatment of prostate cancer with thermal ablation or with cryotherapy.

A clinical trial in Southern California is comparing the outcomes for different focal therapy devices for treatment of prostate cancer.

A registry for the TULSA-PRO is tracking patient outcomes for this device.

A multi-site clinical trial in the US, Canada and Finland is completing a randomized trial comparing the TULSA PRO to radical prostatectomy.  

A clinical trial in Ohio is comparing a single port robotic, partial prostatectomy to focused ultrasound in patients with prostate cancer.

A clinical trial in Southern California is evaluating quality of life questionnaires for patients that have had Sonablate treatments for prostate cancer.

A clinical trial in Bethesda, Maryland is evaluating patients who are having the Tulsa-Pro treatment for low volume and low grade prostate cancer.

A clinical trial in Minnesota is evaluating the use of the Tulsa-Pro for intermediate level patients who have prostate cancer.

A clinical trial in London, UK is doing a long term study of patients treated with the Sonablate system for prostate cancer.

A clinical trial in France is evaluating different methods of target analysis for treatment of patients with prostate cancer.

A clinical trial in France is evaluating the cost of prostate care with retropubic prostatectomy compared to focused ultrasound.

A clinical trial in the Netherlands is evaluating the focal therapy for patients with prostate cancer.

A clinical trial in Norway is comparing HIFU to active surveillance.

A clinical trial in China is substitution focused ultrasound for one of the chemotherapies in patients with metastatic prostate cancer.

A clinical trial in China is comparing the quality of life outcomes from patient who had the Sonablate HIFU system to those that have had prostatectomy.

A clinical trial in Singapore is evaluating a variety of focal therapies, including focused ultrasound, for the use in patients with prostate cancer.

A clinical trial in France is organizing, and will look at the quality of life outcomes from patients who have had either total prostatectomy of focal therapy for prostate cancer.

A clinical trial, the Jupiter Registry, is organizing in Europe for looking at 5 year outcomes after patients have had focal therapy for prostate cancer.

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 >

Manufacturers

Media & Videos

Shreveport hospital first in region to offer noninvasive prostate cancer treatment
Shreveport Times – December 6, 2022

A new treatment option for men battling prostate cancer
ABC15 Arizona – November 15, 2022

WVXU: High-intensity focused ultrasound a new treatment option for men with prostate cancer
UC News – September 19, 2022

Alternative Approach Uses Sound Waves to Treat Prostate Cancer
UC San Diego Health – February 24, 2022

MRI-guided HIFU show strong potential in localized prostate cancer
Urology Times – February 4, 2021

Notable Papers

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

Watfa M, Soputro NA, Al-Bayati A, Daher K, Younis S, Rai S, Bernardino RM, Wang L, Schwen ZR, Olivares R, Autorino R, Kaouk J. Salvage Single-Port Transvesical Robotic Radical Prostatectomy Following High-Intensity Focused Ultrasound (HIFU) Therapy. Int Braz J Urol. 2026;52(3):e20250744. doi: 10.1590/S1677-5538.IBJU.2025.0744. PMID: 41643054

 Schostak M, Peklo E, Peters I, Machtens S, Schlemmer HP, Thomas C, Borkowetz A. Parameters predicting Recurrence after Focal Therapy for Prostate Cancer: Insights from a Multicenter Surveillance Database. Urol Int. 2026 Apr 2:1-20. doi: 10.1159/000551632. PMID: 41926560

 Saeed S, Sommer D, Phillipi M, Houshyar R. Diagnostic performance of PSMA PET/CT and multiparametric MRI for local prostate cancer recurrence after high-intensity focused ultrasound. Curr Probl Diagn Radiol. 2026 Apr 17:S0363-0188(26)00084-8. doi: 10.1067/j.cpradiol.2026.04.015. PMID: 42031651

 Roldan-Testillano R, Rodriguez-Sanchez L, Covarrubias C, Durazo-Ruiz F, Arezki A, Anidjar M, Sanchez-Salas R. Advances in focal therapy for prostate cancer: current modalities, outcomes, and future directions. Prostate Int. 2026 Mar;14(1):1-9. doi: 10.1016/j.prnil.2025.07.002. Epub 2025 Jul 14. PMID: 41908235

 Sebastian NT, Patil D, Patel PR, Jani AB, Hershatter BW, Dhere VR, Godette KD, Salari K, Lorentz CA, Hajiha M, Weiss AD, Joshi SJ, Sanda MG, Patel SA. Utilization, Cost, and Subsequent Salvage Treatment of Ablative Therapies for Localized Prostate Cancer in the United States. Clin Genitourin Cancer. 2026 Apr 1:102556. doi: 10.1016/j.clgc.2026.102556. PMID: 42036260

 Ploussard G, Coloby P, Chevallier T, Occéan BV, Kassab D, Houédé N, Villers A, Rischmann P. Salvage High-intensity Focused Ultrasound for Prostate Cancer Recurrence after Radiotherapy (HIFI-2 Study). Eur Urol Oncol. 2026 Apr 28:S2588-9311(26)00112-4. doi: 10.1016/j.euo.2026.04.007. PMID: 42055879

 Salvaggio G, Midiri F, Gagliardo C, Salerno S, Lupo G, Benfante V, Comelli A, Lo Re G, Galia M, Midiri M. Oncological efficacy, functional outcomes and safety of MR-guided ultrasound ablation (MRgFUS/TULSA) for localized prostate cancer: a scoping review. Radiol Med. 2026 Apr 29. doi: 10.1007/s11547-026-02214-z. PMID: 42056384

 Miszczyk M, Mastroleo F, Kujawska A, Gurwin A, Marvaso G, Kói T, Calleris G, Rasing M, Chin J, Fuller D, Nathan A, Peters M, van der Voort van Zyp J, Jenjitranant P, Hruby G, Soeterik TFW, Francolini G, Exterkate L, Overduin CG, Marra G, Gontero P, Alfarhan AR, Rajwa P, Kishan AU, Jereczek-Fossa BA, Shariat SF, Shariat SF. Local Salvage Therapy Alone for Local Recurrence of Prostate Cancer After Radiotherapy: A Systematic Review and Meta-Analysis. JAMA Oncol. 2026 Apr 30. doi: 10.1001/jamaoncol.2026.1023. PMID: 42060279

 Light A, Peters M, Arya M, Bertoncelli Tanaka M, Dudderidge T, Emara A, Emberton M, Grey A, Hindley R, Laniado M, McCraken S, Moore CM, Nigam R, Noureldin M, Orczyk C, Reddy D, Virdi J, Ahmed M, Albisinni S, Cathcart P, Joniau S, Karnes RJ, Persad R, Rajwa P, Sanchez-Salas R, Shariat SF, Smith JA, Tilki D, van der Poel H, Calleris G, Gontero P, Marra G, Ahmed HU, Shah TT. Salvage Focal Therapy vs Radical Prostatectomy for Localized Radiorecurrent Prostate Cancer. JAMA Oncol. 2026 Apr 1;12(4):364-373. doi: 10.1001/jamaoncol.2025.6448. PMID: 41678176

 Lughezzani G, Celia A, Fasulo V, Marra G, Silvestri T, Vittori G, Stabile A, Mastroianni R, Branchi A, Falagario U, Simone G, Bove P, Iacovelli V, DE Luca S, Ficarra V, Minervini A, Salonia A, Mirone V, Carrieri G, Buffi NM, Lazzeri M, Lazzeri M. The Italian Society of Urology Statement on focal therapy for localized prostate cancer. Minerva Urol Nephrol. 2026 Feb;78(1):1-14. doi: 10.23736/S2724-6051.25.06851-X. PMID: 41697201

 Brazão ÉS Jr, Santos VE, Mourão TC, Gomes DC, Nobre JQC, Brazão GP, de Oliveira RAR, da Silva C, da Costa WH, Guimarães GC, Zequi SC. External validation of the cancer of the prostate risk assessment score to predict treatment failure after high-intensity focused ultrasound. Prostate Int. 2026 Mar;14(1):22-28. doi: 10.1016/j.prnil.2025.09.002. Epub 2025 Sep 12. PMID: 41908230

 Anceschi U, Tufano A, Tuderti G, Mastroianni R, D’Annunzio S, Ferriero MC, Proietti F, Capecchi L, Spadaro G, Iori M, Misuraca L, Lugnani F, Simone G. Predicting 1-Year Trifecta Outcomes After High-Intensity Focused Ultrasound and Cryoablation for Low- and Intermediate-Risk Prostate Cancer. Biomedicines. 2026 Mar 20;14(3):716. doi: 10.3390/biomedicines14030716. PMID: 41898360

 Anceschi U, Basile S, Misuraca L, Mastroianni R, D’Annunzio S, Proietti F, Bove AM, Prata F, Capecchi R, Spadaro G, Ferriero M, Lugnani F, Simone G. Hemigland cryoablation versus high-intensity focused ultrasound for localized prostate cancer: a propensity-weighted comparison of functional and oncologic outcomes. World J Urol. 2026 Mar 26;44(1):269. doi: 10.1007/s00345-026-06378-1. PMID: 41885967

 Zhu D, Malshy K, Cheng Z, Mali K, Shen M, Bandari J, Hollenberg GM, Weinberg EP, Frye TP. Comparison of the Prostate Imaging After Focal Ablation (PI-FAB) and Transatlantic Recommendations for Prostate Gland Evaluation (TARGET) for the Detection of In-Field Prostate Cancer Recurrence on Post-Focal Therapy Prostate Magnetic Resonance Imaging (MRI). Clin Genitourin Cancer. 2026 Apr;24(3):102523. doi: 10.1016/j.clgc.2026.102523. Epub 2026 Feb 18. PMID: 41807146

 Velasquez EL, Titus RS, Mundra V, Riveros C, Miles B, Kaushik D, Abreu AL, Wallis CJD, Satkunasivam R. Real-world functional and oncologic outcomes of prostate gland ablation vs. standard of care therapies for localized prostate: A retrospective cohort study using the TriNetX database. Urol Oncol. 2026 Mar 1;44(5):111037. doi: 10.1016/j.urolonc.2026.111037. PMID: 41771218

 Biolatti LV, Ismail N, Devi A, Zhong J, Bleaney CW, Choudhury A. Unravelling Salvage Re-irradiation for Locally Recurrent Prostate Cancer: Challenges and Complexities. Clin Oncol (R Coll Radiol). 2026 Apr;52:104071. doi: 10.1016/j.clon.2026.104071. Epub 2026 Jan 31. PMID: 41759222

 Aksakal B, Soputro NA, Al-Bayati A, Secin M, Autorino R, Kaouk J, Olivares R. Telesurgery in prostate cancer: a systematic review of clinical applications and future directions. Prostate Cancer Prostatic Dis. 2026 Feb 20. doi: 10.1038/s41391-026-01090-y. PMID: 41721057

Cella L, Fasulo V, Moretto S, Beatrici E, Piccolini A, Avolio PP, Maffei D, Contieri R, Tallari A, Mallia V, Uleri A, Saita A, Hurle R, Casale P, Lazzeri M, Paciotti M, Buffi NM, Lughezzani G. Salvage robotic-assisted radical prostatectomy after targeted high-intensity focused ultrasound: a single-center study on feasibility, oncological and functional outcomes. Front Oncol. 2026 Feb 6;16:1711853. doi: 10.3389/fonc.2026.1711853. eCollection 2026. PMID: 41727652

Roldan-Testillano R, Rodriguez-Sanchez L, Covarrubias C, Durazo-Ruiz F, Arezki A, Anidjar M, Sanchez-Salas R. Advances in focal therapy for prostate cancer: current modalities, outcomes, and future directions. Prostate Int. 2026 Mar;14(1):1-9. doi: 10.1016/j.prnil.2025.07.002. Epub 2025 Jul 14. PMID: 41908235

Ono Y, Kohada Y, Tasaka S, Miyamoto S, Hayashi T, Honda Y, Kitamura N, Tasaka R, Kobatake K, Sekino Y, Kitano H, Goto K, Goriki A, Hieda K, Kato M, Takeshima Y, Hinata N. Combining Prostate-Specific Antigen Density With PI-RADS to Improve the Detection of Clinically Significant Prostate Cancer at MRI/TRUS Fusion-Targeted Re-Biopsy. Prostate. 2026 Apr;86(5):582-591. doi: 10.1002/pros.70117. Epub 2025 Dec 23. PMID: 41431453

Watfa M, Soputro NA, Al-Bayati A, Daher K, Younis S, Rai S, Bernardino RM, Wang L, Schwen ZR, Olivares R, Autorino R, Kaouk J. Salvage Single-Port Transvesical Robotic Radical Prostatectomy Following High-Intensity Focused Ultrasound (HIFU) Therapy. Int Braz J Urol. 2026;52(3):e20250744. doi: 10.1590/S1677-5538.IBJU.2025.0744. PMID: 41643054

Light A, Peters M, Arya M, Bertoncelli Tanaka M, Dudderidge T, Emara A, Emberton M, Grey A, Hindley R, Laniado M, McCraken S, Moore CM, Nigam R, Noureldin M, Orczyk C, Reddy D, Virdi J, Ahmed M, Albisinni S, Cathcart P, Joniau S, Karnes RJ, Persad R, Rajwa P, Sanchez-Salas R, Shariat SF, Smith JA, Tilki D, van der Poel H, Calleris G, Gontero P, Marra G, Ahmed HU, Shah TT. Salvage Focal Therapy vs Radical Prostatectomy for Localized Radiorecurrent Prostate Cancer. JAMA Oncol. 2026 Feb 12:e256448. doi: 10.1001/jamaoncol.2025.6448. PMID: 41678176

Bitton RR, Vertosick E, Khandwala Y, Korol G, Vickers A, Ehdaie B, Sonn G, Ghanouni P. Optimizing prostate cancer treatment with MR-guided focused ultrasound: the role of expanded ablation-to-lesion volume ratio. Eur Radiol. 2026 Jan 16. doi: 10.1007/s00330-025-12217-5. PMID: 41540208

Roldan-Testillano R, Rodriguez-Sanchez L, Rodríguez Socarrás ME, de Andrés Boville G, Durazo-Ruiz F, Gómez Rivas J, Alfambra Fernández H, Sánchez Macías J, Bianco FJ, Miñana López B, Sanchez-Salas R. The role of focal therapy for localized prostate cancer: From diagnosis to ablation. Actas Urol Esp (Engl Ed). 2026 Jan 5:501918. doi: 10.1016/j.acuroe.2026.501918. PMID: 41500454

Dokania S, Aphale P, Shekhar H. Optimizing Transurethral Ultrasound Ablation for Localized Prostate Cancer: Lessons from Functional and Imaging Outcomes. J Vasc Interv Radiol. 2026 Jan;37(1):107890. doi: 10.1016/j.jvir.2025.10.021. Epub 2025 Oct 28. PMID: 41167300

Tricard T, Cazzato RL. Comments on Optimizing Transurethral Ultrasound Ablation for Localized Prostate Cancer: Lessons from Functional and Imaging Outcomes. J Vasc Interv Radiol. 2026 Jan;37(1):107894. doi: 10.1016/j.jvir.2025.10.025. Epub 2025 Oct 27. PMID: 41161408

Li H, Cai Z, He P, Wu Y, Lu L, Gao Y, Sun L, Huang L, Dong X, Liu Z. Mechanical destruction of canine prostate using a novel low-intensity histotripsy based on a perfluoropentane-filled sodium alginate scaffold. Int J Hyperthermia. 2025 Dec;42(1):2579893. doi: 10.1080/02656736.2025.2579893. Epub 2025 Oct 29. PMID: 41158084

Maurer A, Muehlematter UJ, Sivakumar T, Mortezavi A, Heimer J, Kaufmann B, Beintner-Skawran S, Messerli M, Huellner MW, Eberli D, Burger IA. High-Intensity Focused Ultrasound in Prostate Cancer: Can PSMA PET Improve Focal Therapy Outcomes? J Nucl Med. 2025 Dec 4:jnumed.125.271318. doi: 10.2967/jnumed.125.271318. PMID: 41344858

Collins K, Cheng L. Treatment-related changes in the prostate: past, present and future therapies. Histopathology. 2026 Jan;88(1):40-52. doi: 10.1111/his.15507. PMID: 41384710

Koehler J, Lama D, Mendez M, Hsu WW, Oto A, Szmulewitz R, Sidana A. Phase II trial protocol of focal prostate ablation combined with androgen deprivation therapy for prostate cancer treatment. PLoS One. 2025 Dec 16;20(12):e0337828. doi: 10.1371/journal.pone.0337828. eCollection 2025. PMID: 41401176

Mercier J, Bento L, Cassou-Mounat T, Prudhomme T, Lagarde S, Game X, Soulie M, Thoulouzan M, Bajeot AS, Roumiguie M. Post-HIFU surveillance of localized prostate cancer: role of PSMA-PET imaging versus the standard PSA-mpMRI protocol. World J Urol. 2025 Dec 27;44(1):68. doi: 10.1007/s00345-025-06163-6. PMID: 41454965

Yee CH, Chiu PK, Liu AQ, Wong HF, Chan WHC, Lo KL, Chan CK, Chan R, Cho CC, Hung HY, Teoh JYC, Ng CF. Multimodality focal therapy for prostate cancer: outcome of the à la carte approach in clinical practice. Prostate Int. 2025 Dec;13(4):201-206. doi: 10.1016/j.prnil.2025.03.006. Epub 2025 Mar 24. PMID: 41472926

Korn SM, Qian Z, Zurl H, Piccolini A, Pohl KK, Xiao B, Lipsitz S, Zhang J, Kibel AS, Hübner NA, Moore CM, Shariat SF, Trinh QD, Cole AP. Claims-Based Analysis of National Utilization Patterns and Regional Variability of Prostate Cancer Ablative Therapies: A Medicare Study. J Endourol. 2025 Nov 18. doi: 10.1177/08927790251388065. PMID: 41253389

Noun J, Blachman-Braun R, Lee E, Pinto PA. Focal Therapies for Localized Prostate Cancer. Urol Clin North Am. 2026 Feb;53(1):115-134. doi: 10.1016/j.ucl.2025.09.010. Epub 2025 Nov 5. PMID: 41265994

Click here for additional references from PubMed.

Video courtesy of SonaCare Medical