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 multi-site clinical trial in the US, Canada and Finland is completing 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)
Guang ZLP, Kristensen G, Røder A, Brasso K. Oncological and Functional Outcomes of Whole-Gland HIFU as the Primary Treatment for Localized Prostate Cancer: A Systematic Review. Clin Genitourin Cancer. 2024 Aug;22(4):102101. doi: 10.1016/j.clgc.2024.102101. Epub 2024 Apr 25. PMID: 38811288
Babalola O, Gebben D, Tarver ME, Joyce Lee TH, Wang S, Siddiqui MM, Sonn GA, Viviano CJ. Patient Preferences for Benefit and Risk Associated With High Intensity Focused Ultrasound for the Ablation of Prostate Tissue in Men With Localized Prostate Cancer. Clin Genitourin Cancer. 2024 Aug;22(4):102113. doi: 10.1016/j.clgc.2024.102113. Epub 2024 May 7. PMID: 38845330
Solyanik O, Chaloupka M, Clevert DA, Schmidt VF, Ingenerf M, Kazmierczak P, Stief CG, Ricke J, Apfelbeck M. Prospective close monitoring of the effect of vascular-targeted photodynamic therapy and high intensity focused ultrasound of localized prostate cancer by multiparametric magnetic resonance imaging. World J Urol. 2024 Aug 1;42(1):462. doi: 10.1007/s00345-024-05143-6. PMID: 39088086
Bitton RR, Shao W, Chodakeiwitz Y, Brunsing RL, Sonn G, Rusu M, Ghanouni P. Intraprocedural Diffusion-weighted Imaging for Predicting Ablation Zone during MRI-guided Focused Ultrasound of Prostate Cancer. Radiol Imaging Cancer. 2024 Sep;6(5):e240009. doi: 10.1148/rycan.240009. PMID: 39212524
Toeama B, Perlis N, Grootendorst P, Orovan W, Papadimitropoulos E. A costing and health-related quality of life study of high intensity focused ultrasound in primary treatment of localized low or intermediate risk prostate cancer in Ontario. Can J Urol. 2024 Aug;31(4):11963-11970. doi: 10.1148/rycan.240009. PMID: 39217521
Kumar YN, Singh Z, Wang YN, Kanabolo D, Chen L, Bruce M, Vlaisavljevich E, True L, Maxwell AD, Schade GR. A comparative study of histotripsy parameters for the treatment of fibrotic ex-vivo human benign prostatic hyperplasia tissue. Sci Rep. 2024 Sep 2;14(1):20365. doi: 10.1038/s41598-024-71163-2. PMID: 39223181
Creta M, Shariat SF, Marra G, Gontero P, Rossanese M, Morra S, Teoh J, Kishan AU, Karnes RJ, Longo N. Local salvage therapies in patients with radio-recurrent prostate cancer following external beam radiotherapy: a systematic review and meta-analysis. Prostate Cancer Prostatic Dis. 2024 Sep 2. doi: 10.1038/s41391-024-00883-3. PMID: 39223232
Parry MG, Sujenthiran A, Nossiter J, Morris M, Berry B, Nathan A, Aggarwal A, Payne H, van der Meulen J, Clarke NW. Reply to: Letter to the editor regarding the article ‘Prostate cancer outcomes following whole-gland and focal high-intensity focused ultrasound’. BJU Int. 2024 Aug;134(2):313. doi: 10.1111/bju.16348. Epub 2024 Mar 22. PMID: 38515403
Ajami T, Blachman-Braun R, Porto JG, Ritch CR, Gonzalgo ML, Punnen S, Shah HN, Parekh DJ, Nahar B. Combined holmium laser enucleation of the prostate with high-intensity focused ultrasound in treating patients with localized prostate cancer in a prostate with volume > 60 g: Oncological and functional outcomes from single-institution study. Urol Oncol. 2024 Sep;42(9):289.e1-289.e6. doi: 10.1016/j.urolonc.2024.04.022. Epub 2024 May 24. PMID: 38789378
Pressler L, Pressler M. Focal Therapy in Grade Group 3 Prostate Cancer. Curr Urol Rep. 2024 Jul 2. doi: 10.1007/s11934-024-01211-x. PMID: 38954356
Pausch AM, Elsner C, Rupp NJ, Eberli D, Hötker AM. MRI-based monitoring of prostate cancer after HIFU: Inter-reader agreement and diagnostic performance of the PI-FAB score. Eur J Radiol. 2024 Apr 10;175:111463. doi: 10.1016/j.ejrad.2024.111463. PMID: 38615502
Chinenov DV, Shpot EV, Chernov YN, Gerasimov AN, Kazachevskaya LY, Lyapichev KA, Ismailov HM, Tsukkiev ZK, Korolev DO, Rapoport LM. Evaluation of functional and oncological outcomes of localized prostate cancer after different minimally invasive therapeutic methods: A single center experience. Urologia. 2024 Jan 21:3915603231226366. doi: 10.1177/03915603231226366. PMID: 38247121
Fugaru I, Bouhadana D, Marcq G, Moryousef J, Rompré-Brodeur A, Meng A, Loutochin O, Loutochin G, Anidjar M, Bladou F, Sanchez-Salas R. Partial gland ablation with high intensity focal ultrasound impact on genito-urinary function and quality of life: our initial experience. Can J Urol. 2024 Feb;31(1):11784-11792. doi: 10.3390/jcm13040931. PMID: 38401258
Yang J, Xiong X, Liao X, Zheng W, Xu H, Yang L, Wei Q. Nonsurgical salvage options for locally recurrent prostate cancer after primary definitive radiotherapy: A systematic review and meta-analysis. Int J Surg. 2024 Feb 9. doi: 10.1097/JS9.0000000000001164. PMID: 38348896
Porto JG, Titus R, Camargo F, Bhatia A, Ahie N, Blachman-Braun R, Malpani A, Lopategui DM, Herrmann TRW, Marcovich R, Shah HN. Minimally invasive techniques in quest of Holy Grail of surgical management of enlarged prostates: a narrative review. World J Urol. 2024 Jan 13;42(1):35. doi: 10.1007/s00345-023-04747-8. PMID: 38217727
Besiroglu H. Re: ‘Prostate cancer outcomes following whole-gland and focal high-intensity focused ultrasound’. BJU Int. 2024 Jan 18. doi: 10.1111/bju.16277. PMID: 38235931
Shoji S. Focal therapy with high-intensity focused ultrasound for localized prostate cancer: approval as advanced medical care and future outlook. J Med Ultrason (2001). 2024 Jan;51(1):1-3. doi: 10.1007/s10396-023-01401-z. Epub 2024 Jan 22. PMID: 38252181
Mattlet A, Limani K, Alexandre P, Hawaux E, Abou Zahr R, Aoun F, Diamand R. External validation of biochemical recurrence definition to predict oncologic outcomes following focal therapy for localized prostate cancer using high intensity focused ultrasound. Prostate. 2023 Dec;83(16):1564-1571. doi: 10.1002/pros.24614. Epub 2023 Aug 13. PMID: 37574824
Adamo DA, Greenwood BM, Ghanouni P, Arora S. MR Imaging-Guided Prostate Cancer Therapies. Radiol Clin North Am. 2024 Jan;62(1):121-133. doi: 10.1016/j.rcl.2023.06.012. Epub 2023 Jul 28. PMID: 37973238
Click here for additional references from PubMed.
Video courtesy of SonaCare Medical
