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, New York, and Virginia. 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 traditionaly 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.

Pre-clinical Laboratory Studies

Pre-clinical 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

Tay KJ, Cheng CWS, Lau WKO, Khoo J, Thng CH, Kwek JW. Focal Therapy for Prostate Cancer with In-Bore MR-guided Focused Ultrasound: Two-Year Follow-up of a Phase I Trial-Complications and Functional Outcomes. Radiology. 2017 Jun 26:161650. doi: 10.1148/radiol.2017161650.

Jones TA, Chin J, Mcleod D, Barkin J, Pantuck A, Marks LS. High-Intensity Focused Ultrasound for Radio-recurrent Prostate Cancer: A North American Clinical Trial. J Urol. 2017 Jun 23. pii: S0022-5347(17)76734-1. doi: 10.1016/j.juro.2017.06.078.

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.

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.

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.

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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