Benign Prostatic Hyperplasia (BPH)

FDA Approved square

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 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 Ablatherm.HIFU.

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. It is about the size of a chestnut and is internally located around the urethra directly below the bladder.

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 particularly common among older men. According to the National Institutes of Health, 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 United States. BPH is not cancerous, but it can cause many different urinary problems, such as frequent urge to urinate, difficulty urinating or getting up at night to urinate. Although the prostate continues to grow with age, the exact cause of BPH is not known.

Prostate cancer is the fourth most common cancer worldwide, after lung, breast, and colorectal cancer. 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 (PSA, rectal examination, and biopsy). If diagnosed early, prostate cancer is very treatable. In the U.S., prostate cancer is the most common type of cancer in men, with 190,000 new cases and 28,600 deaths reported each year. It is the second leading cause of cancer death in American men, behind lung cancer.

Treatment Options

BPH

Watchful waiting or active surveillance is common for men with BPH whose symptoms are mild. With watchful waiting, health care providers monitor patients regularly, but do not prescribe active treatment. For men with moderate to severe symptoms, BPH treatment options may include oral medications, minimally invasive procedures, and surgery.

Oral medication
The two main medications for management of BPH are alpha blockers and 5α-reductase inhibitors. The alpha blockers relax the smooth muscle in the prostate and bladder neck, and the 5α-reductase inhibits production of an androgen hormone which plays a part in the enlargement of the prostate.

Minimally Invasive Procedures
Transurethral needle ablation (TUNA) is a common, minimally invasive procedure for treatment of BPH. With this procedure, a needle is inserted into the prostate through the urethra and emits low-frequency radio waves that heat and kill prostate tissue, shrinking it over time and relieving pressure on the urethra. Another common procedure, transurethral microwave thermotherapy, uses high-frequency radio waves in a similar manner.

Surgery
Transurethral resection of the prostate (TURP) is the gold standard of surgical procedures to treat BPH. The surgeon inserts an endoscope through the urethra and removes the prostatic tissue surrounding it. Other surgical procedures can use laser technology to vaporize prostate tissue surrounding the urethra.


PROSTATE CANCER

Some types of prostate cancer grow slowly and may need minimal or no treatment, while other types are aggressive and can spread quickly. For men with very early-stage prostate cancer, immediate treatment may not be necessary. In these situations, doctors may recommend active surveillance or watchful waiting. For men with localized prostate cancer requiring treatment, the choice of therapy depends on a number of factors including cancer stage, histologic grade, presence of comorbidities, and patient preferences. Treatment options may include: radical prostatectomy (the most common treatment), radiation, androgen deprivation therapy, or cryoablation. Learn more >

Potential 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.

Focused Ultrasound Treatment 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. 

While we attempt to keep the list of sites complete, since approval, there have been many purchases of the FUS systems. We update this list periodically, but for the latest information on availability, we suggest reaching out to the manufacturers to inquire about the closest site to you. Their websites are EDAP and SonaCare Medical.

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.

While the 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. Their websites are EDAP (www.edap-tms.com) and Sonacare Medical (sonacaremedical.com).

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.

Patient Advocacy

The following organizations offer information about BPH and prostate cancer:

  • The Men's Health Network provides health promotion messages and tools, screening, educational materials, advocacy opportunities, and patient navigation to men, boys, and their families.
  • The American Cancer Society provides patient support and education, research support, and advocacy opportunities.

Notable Papers

Aoun F, Marcelis Q, Roumeguère T. Minimally invasive devices for treating lower urinary tract symptoms in benign prostate hyperplasia: technology update. Res Rep Urol. 2015 Aug 19;7:125-36. doi: 10.2147/RRU.S55340. eCollection 2015.

Khokhlova VA, Fowlkes JB, Roberts WW, Schade GR, Xu Z, Khokhlova TD, Hall TL, Maxwell AD, Wang YN, Cain CA. Histotripsy methods in mechanical disintegration of tissue: towards clinical applications. Int J Hyperthermia. 2015 Mar;31(2):145-62. doi: 10.3109/02656736.2015.1007538. Epub 2015 Feb 24.

Thiruchelvam N. Surgical therapy for benign prostatic hypertrophy/bladder outflow obstruction. Indian J Urol. 2014 Apr;30(2):202-7. doi: 10.4103/0970-1591.126907.

Roberts WW. Development and translation of histotripsy: current status and future directions. Curr Opin Urol. 2014 Jan;24.

Schade GR, Styn NR, Ives KA, Hall TL, Roberts WW. Prostate histotripsy: evaluation of prostatic urethral treatment parameters in a canine model. BJU Int. 2013 Oct 31

Roberts WW, Teofilovic D, Jahnke RC, Patri J, Risdahl JM, Bertolina JA, Histotripsy of the Prostate Using a Commercial System in a Canine Model, J Urol. 2013 Sep 6

Van Hest P, D'Ancona F. Update in minimal invasive therapy in benign prostatic hyperplasia. Minerva Urol Nefrol. 2009 Sep;61(3):257-68.

Lü J, Hu W, Wang W. Sonablate-500 transrectal high-intensity focused ultrasound (HIFU) for benign prostatic hyperplasia patients. J Huazhong Univ Sci Technolog Med Sci. 2007 Dec;27(6):671-4.

Madersbacher S, Schatzl G, Djavan B, Stulnig T, Marberger M. Long-term outcome of transrectal high- intensity focused ultrasound therapy for benign prostatic hyperplasia. Eur Urol. 2000 Jun;37(6):687-94.

See more publications

     

Share this page