HIFU (High Intensity Focused Ultrasound)
HIFU is the newest and the least invasive of all of the alternatives to the radical prostatectomy. There are no cuts, no needles, and it can be done under a local spinal anesthesia. You can go out to diner the same day as the treatment. You can return to work a few days later.
What is HIFU therapy?
High intensity focused ultrasound uses ultrasound energy precisely focused to rapidly heat tissue to 100 degrees Celsius for 2-3 seconds, effectively destroying tissue. Similar to what happens when sunlight is focused through a magnifying lens, precise focusing of ultrasound energy elevates the temperature of the tissue in the focal zone very rapidly while intervening tissue is kept at a safe temperature. The difference is that instead of light as an energy source ultrasound is used, and instead of a magnifying lens to focus the energy an ultrasound transducer is used. The imaging capabilities of the technology allow for identification and preservation of vital structures such as the neurovascular bundles that contain the nerves and arteries vital to maintaining erections. Also the apex of the prostate and the external sphincter can be easily seen and identified, thus avoiding the sphincter muscles that might damage continence.
There are two machines on the market today.
EDAP makes the Ablatherm. This is a French company and has been doing HIFU for prostate cancer since 1995. The machine is limited to 30 gram prostates (relatively small prostates). It uses one of three standard power settings and the lesion created is 3mm X 3mm X 22mm. The probe is 50% larger than the Sonoblate 500. There is very little user input once the machine is turned on (set it and forget it). Often a TURP (surgical removal of the inside of the prostate or “roto-rooter”) is performed before the HIFU procedure to make the prostate small enough to do the Ablatherm procedure. Cure rate is 90% for early prostate cancers with PSA less than 10 and Gleason score 6. For more advanced cancers with a palpable nodule and with PSA of 20 or less and Gleason score 7 or more the cure rate is 80%. This is similar to other forms of treatment such as radical prostatectomy, radiation therapy, or cryoablation. The PSA should drop to 0.2 after a successful treatment. Incontinence is minimal and potency is 50%. Treatment takes 2 to 3 hours to perform.
Focus Surgery makes the Sonablate 500 in Indianapolis. The current machine has been in clinical use since 2001. It has two focal length probes, 3 cm and either a 4 or a 5 cm probe. The HIFU lesion created is 3mm X 3mm X 9mm in size and is smaller (i.e., more precise) than the lesion created by the Ablatherm machine. It can treat glands up to 40 or 50 grams in size (small to moderate in size). Because the lesion produced is small and because the urologist is actively adjusting the machine during the entire procedure, the nerves and the sphincter muscles can be accurately identified and preserved. This is time consuming and treatment generally takes 2 to 4 hours to perform. Incontinence is 0.6% and impotence can be as low as 10% with nerve sparing techniques (20% figures are standard in the literature). The 4 year PSA cure rate is 94% (Uchida et al, British J Urology, 2006) with early cancers. 92% of men get a PSA of 0.2 ng/mL or lower three months after treatment. Worldwide over 6,000 treatments have been done with the Sonablate 500 as of 2009. Who is a candidate? Anyone with a PSA less than 15 and a prostate less than 50 grams with a height of 4 ½ cm or less is a candidate for HIFU. If you are interested in HIFU treatment for prostate cancer contact your urologist and have your Gleason’s score, biopsy report, PSA, prostate size in grams, and the height of the prostate in centimeters available when you call.
HIFU machines are being clinically tested by the FDA in the United States at present. HIFU should be available in the USA in 2011 or 2012.
International HIFU based in Charlotte North Carolina is the exclusive distributor for the Sonoblate 500 in North America, Central America and South America. Presently the procedure is currently being done under the direction of International HIFU in Toronto, Niagara Falls, Montreal, Nassau, Cancun, and Puerto Vallarta. The site in Toronto is run by Urologists from the medical school. The cost is $25,000. The procedure will not be covered by US insurance until it gets FDA approval.
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