Prostate Cancer

FDA Approved square

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

Two focused ultrasound systems for destroying diseased prostate tissue are approved by the Food and Drug Administration. In addition, Medicare has agreed to cover this treatment, which will hopefully impact the commercial carriers to do the same.

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.

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.

Advantages:

  • Focused ultrasound 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).
  • Precise targeting minimizes damage to non-targeted healthy tissue.
  • 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.
  • Treatment can be a complement to drug therapy, enabling enhanced delivery of chemotherapy or immunotherapy to tumors.
  • Focused ultrasound may potentially induce an anti-tumor immune response.
 

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 >

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. These systems deliver care outside of the MRI facility, so they are found in surgery centers and surgical suites, as well as in hospitals. There are even some mobile units that provide care adjacent to physicians' offices.

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 – EDAP and SonaCare Medical.

There are additional sites that use mobile focused ultrasound equipment. These sites may not be listed on the EDAP or SonaCare sites, and the best way to find them is to contact local urologists to see if they have focused ultrasound capability.

Clinical Trials Square

Clinical Trials

For a full list of know clinical trials, please see here.

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

Regulatory Approval and Reimbursement

Outside Approval Square

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: the United States, 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, Medicare coverage for focused ultrasound prostate treatment was announced in July 2017. There are several steps in this process, so individuals should check with their physician's office to confirm that payments have begun in their locality. Although commercial insurance companies have not traditionally covered this treatment, they may begin to do so after Medicare's decision. It is best to check with your insurance company, as changes are likely following Medicare's coverage approval.

Preclinical Laboratory Studies

Preclinical studies are underway to investigate the use of various mechanisms of focused ultrasound in the treatment of prostate cancer. Examples of these studies include:
  • Focused ultrasound to induce an immune response that could be combined with immunotherapeutics to treat both local and systemic disease.
  • Focused ultrasound to enable targeted delivery and/or activation of drugs via carrier vehicles (e.g., microbubbles, nanoparticles, liposomes) to enable delivery of high concentrations in the tumor with minimal systemic side effects.
  • Non-thermal mechanical destruction of tumor using a type of focused ultrasound called histotripsy.

Additional Resources

Prostate Cancer Foundation

American Cancer Society 

Men's Health Network

Notable Papers

Linares-Espinós E, Carneiro A, Martínez-Salamanca JI, Bianco F, Castro-Alfaro A, Cathelineau X, Valerio M, Sanchez-Salas R. New technologies and techniques for prostate cancer focal therapy: a review of the current literature. Minerva Urol Nefrol. 2018 Apr 16. doi: 10.23736/S0393-2249.18.03094-1.

Apfelbeck M, Clevert DA, Ricke J, Stief C, Schlenker B. Contrast enhanced ultrasound (CEUS) with MRI image fusion for monitoring focal therapy of prostate cancer with high intensity focused ultrasound (HIFU)1. Clin Hemorheol Microcirc. 2018 Apr 7. doi: 10.3233/CH-189123.

Lotte R, Lafourcade A, Mozer P, Conort P, Barret E, Comperat E, Ezziane M, de Guibert PJ, Tavolaro S, Belin L, Boudghene F, Lucidarme O, Renard-Penna R. Multiparametric MRI for Suspected Recurrent Prostate Cancer after HIFU:Is DCE still needed? Eur Radiol. 2018 Apr 9. doi: 10.1007/s00330-018-5352-z.

Durán-Rivera A, Montoliu García A, Juan Escudero J, Garrido Abad P, Fernández Arjona M, López Alcina E. High-intensity focused ultrasound therapy for the treatment of prostate cancer: Medium-term experience. Actas Urol Esp. 2018 Mar 21. pii: S0210-4806(18)30005-6. doi: 10.1016/j.acuro.2017.11.007.

Golan R, Bernstein A, Sedrakyan A, Daskivich TJ, Du DT, Ehdaie B, Fisher B, Gorin MA, Grunberger I, Hunt B, Jiang HH, Kim HL, Marinac-Dabic D, Marks LS, McClure TD, Montgomery JS, Parekh DJ, Punnen S, Scionti S, Viviano CJ, Wei JT, Wenske S, Wysock JS, Rewcastle J, Carol M, Oczachowski M, Hu JC. Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies. J Urol. 2018 Jan 4. pii: S0022-5347(18)30007-7. doi: 10.1016/j.juro.2017.12.058.

Click here for additional references from PubMed.

Video courtesy of SonaCare Medical