Prostate Cancer

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Focused ultrasound treatment for the prostate is now available in the United States.

Two systems for destroying diseased prostate tissue are now approved by the Food and Drug Administration.

Focused Ultrasound Therapy

Focused ultrasound is a non-invasive, 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. The 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.

Outside Approval Square

The technology has been successfully used to treat a wide variety of prostate related diagnoses, including benign prostatic hyperplasia (BPH) and prostate cancer. Focal prostate gland ablation or diffuse prostate gland ablation is possible depending on the clinical scenario. More than 50,000 men around the world have been treated with focused ultrasound for prostate cancer. It is the leading clinical application of the technology -- more than 50% of all focused ultrasound procedures performed to date were for prostate cancer.

There are two focused ultrasound systems approved in the US for the ablation (destruction) of prostate tissue - SonaCare’s Sonablate and EDAP’s Focal One.

Clinical Trials Square

About Prostate Disease

The prostate gland is the part of the male reproductive system that produces the ejaculatory fluid that carries sperm cells. 

Prostate cancer is the fourth most common cancer worldwide. It can affect the entire prostate or just a small portion of it, and the severity of the disease is based on a combination of the scores from the screening tests. If diagnosed early, prostate cancer is very treatable. In the US, prostate cancer is the most common type of cancer in men, with 190,000 new cases and 28,600 deaths reported each year. 

With aging, the prostate may enlarge for unknown reasons, resulting in a condition called benign prostatic hyperplasia (BPH). It is the most common disorder of the prostate gland and is common among older men. BPH affects approximately 50 percent of men between the ages of 51 and 60, and up to 90 percent of men older than 80 years in the US. BPH can cause urinary problems, such as frequent urge to urinate, difficulty urinating or getting up at night to urinate. 

Benefits of Focused Ultrasound

The potential benefits of focused ultrasound for the treatment of prostate cancer include:

  • It is a non-invasive, low-morbidity treatment with a short recovery time and a quick return to work and the activities of normal life (usually the next day).
  • A single therapy session is usually all that is required.
  • 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, which means that it is possible to repeat treatment, it is possible to offer it as a salvage therapy for patients who fail radiation treatment, and it does not prevent pursuing other treatment options.

prostate chart icon 300Treatment Sites

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. Find a center near you >

Clinical Trials

There is an ongoing study evaluating histotripsy for treatment of patients with BPH. There are also several ongoing clinical trials for the treatment of prostate cancer. Please see here for a list.

One trial is investigating the safety and efficacy of a new device to treat low to intermediate risk prostate lesions. This trial is taking place at several sites in the US, including in California, Florida, Massachusetts, Michigan, Minnesota, New York, and Virginia. Click here for more trial information and contact information for each site.

While the FUS Foundation attempts to keep the list of sites complete, since approval, there have been many purchases of the FUS systems. For the latest information on availability, we recommend contacting the manufacturers - EDAP and SonaCare Medical.

Regulatory Approval and Reimbursement

In addition to the United States, the following geographical regions have one or more focused ultrasound devices approved for the treatment of prostate cancer as either a primary or salvage treatment: Europe, Canada, Russia, Australia, Korea, Malaysia, Indonesia, South America, and the Middle East.

Some European countries have insurance coverage; in other countries, coverage may be available on a case and site basis. In the United States, most insurance and Medicare are not covering focused ultrasound care for prostate conditions.

Additional Information

American Cancer Society 

Men's Health Network

Notable Papers

Fakhrejahani F, Madan RA, Dahut WL. Management Options for Biochemically Recurrent Prostate Cancer. Curr Treat Options Oncol. 2017 May;18(5):26. doi: 10.1007/s11864-017-0462-4. 

Golan R, Bernstein AN, McClure TD, Sedrakyan A, Patel NA, Parekh DJ, Marks LS, Hu JC. Partial gland treatment of prostate cancer utilizing high-intensity focused ultrasound in the primary and salvage setting: a systematic review. J Urol. 2017 Apr 19. pii: S0022-5347(17)54786-2. doi: 10.1016/j.juro.2017.03.137.

Mertan FV, Greer MD, Borofsky S, Kabakus IM, Merino MJ, Wood BJ, Pinto PA, Choyke PL, Turkbey B. Multiparametric Magnetic Resonance Imaging of Recurrent Prostate Cancer. Top Magn Reson Imaging. 2016 May 16.

Woodrum DA, Kawashima A, Gorny KR, Mynderse LA. Targeted prostate biopsy and MR-guided therapy for prostate cancer. Abdom Radiol (NY). 2016 May;41(5):877-88. doi: 10.1007/s00261-016-0681-3.

Tyson MD, Penson DF, Resnick MJ. The comparative oncologic effectiveness of available management strategies for clinically localized prostate cancer. Urol Oncol. 2016 Apr 28. pii: S1078-1439(16)30006-0. doi: 10.1016/j.urolonc.2016.03.021.

Duijzentkunst DA, Peters M, van der Voort van Zyp JR, Moerland MA, van Vulpen M. Focal salvage therapy for local prostate cancer recurrences after primary radiotherapy: a comprehensive review. World J Urol. 2016 Mar 24.

Yuh B, Liu A, Beatty R, Jung A, Wong JY. Focal therapy using magnetic resonance image-guided focused ultrasound in patients with localized prostate cancer. J Ther Ultrasound. 2016 Mar 11;4:8. doi: 10.1186/s40349-016-0054-y. eCollection 2016.

Dickinson L, Arya M, Afzal N, Cathcart P, Charman SC, Cornaby A, Hindley RG, Lewi H, McCartan N, Moore CM, Nathan S, Ogden C, Persad R, van der Meulen J, Weir S, Emberton M, Ahmed HU. Medium-term Outcomes after Whole-gland High-intensity Focused Ultrasound for the Treatment of Nonmetastatic Prostate Cancer from a Multicentre Registry Cohort. Eur Urol. 2016 Mar 4. pii: S0302-2838(16)00244-X. doi: 10.1016/j.eururo.2016.02.054.

Sivaraman A, Barret E. Focal Therapy for Prostate Cancer: An "À la Carte" Approach. Eur Urol. 2016 Jan 5. pii: S0302-2838(15)01223-3. doi: 10.1016/j.eururo.2015.12.015.

van Breugel JM, Nijenhuis RJ, Ries MG, Toorop RJ, Vonken EJ, Wijlemans JW, van den Bosch MA. Non-invasive magnetic resonance-guided high intensity focused ultrasound ablation of a vascular malformation in the lower extremity: a case report. J Ther Ultrasound. 2015 Dec 30;3:23. doi: 10.1186/s40349-015-0042-7. eCollection 2015.

Holtzman AL, Hoppe BS, Letter HP, Bryant C, Nichols RC, Henderson RH, Mendenhall WM, Morris CG, Williams CR, Li Z, Mendenhall NP. Proton Therapy as Salvage Treatment for Local Relapse of Prostate Cancer Following Cryosurgery or High-Intensity Focused Ultrasound. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):465-71. doi: 10.1016/j.ijrobp.2015.12.351. Epub 2015 Dec 19.

Copelan A, Hartman J, Chehab M, Venkatesan AM. High-Intensity Focused Ultrasound: Current Status for Image-Guided Therapy. Semin Intervent Radiol. 2015 Dec;32(4):398-415. doi: 10.1055/s-0035-1564793.

van Velthoven R, Aoun F, Marcelis Q, Albisinni S, Zanaty M, Lemort M, Peltier A, Limani K. A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer. Prostate Cancer Prostatic Dis. 2016 Mar;19(1):79-83. doi: 10.1038/pcan.2015.55. Epub 2015 Nov 24.

Click here for additional references from PubMed.

Video courtesy of SonaCare Medical


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