High Intensity Focused Ultrasound (HIFU)

A PROMISING NEW TECHNOLOGY FOR THE TREATMENT OF SOLID TUMORS

INTRODUCTION
High Intensity Focused Ultrasound (HIFU) is a non-invasive new treatment modality for solid tumors.1 Using sound waves, which when focused create heat at a specific point, tumors can be destroyed with little damage to surrounding, healthy tissue.

HIFU is a promising new technology because it is a procedure that does not involve incisions or needle insertions and, as opposed to many forms of radiation, can be repeated multiple times.

There are two types of HIFU technology: The first is transrectal HIFU, generally used for prostate cancer whereby the sound waves are directed at the prostate using a rectal probe. The second is extracorporeal HIFU, whereby the sound waves are directed at tumor lesions using a device located outside of the body.

HIFU is currently FDA and CE (European) approved for the treatment of uterine fibroids. It is also available for the treatment
of prostate cancer in over one hundred clinical centers in Europe, South America, and Canada, and is currently being used in various clinical trials here in the United States. In Europe, HIFU is also approved for tumors of the liver and kidney. Additionally, in China, England, Malaysia, Korea, and Japan, HIFU treatment of various other solid tumor cancers is approved and available to patients who are able to travel.

WHY HIFU WORKS
Ultrasound is sound with a frequency range above the threshold of human hearing. While the upper limit for humans is around 20kHz, HIFU typically operates in a frequency range from 250kHz to 2000kHz. Ultrasound waves pass through the body tissues causing compression (increased pressure) and rarefaction (decreased pressure). This energy is absorbed by the body and converted into heat. With HIFU, these waves are focused on a small target to generate intense heat at a specific point, similar to the way one can focus light with a magnifying glass. Only at the precise target, where the sound waves converge, are the energy levels of the ultrasound high enough to bring about a rise in temperature to cause instantaneous tumor cell death. Cells die when they are exposed to temperatures above 56ºC (133ºF) for at least one second; during HIFU, the temperatures are usually raised to 80ºC (176ºF) or higher at the precisely defined target area. The surrounding tissues, meanwhile, are not damaged because the energy is not focused enough to generate this kind of heat, making HIFU a non-invasive procedure much safer than many types of radiation or surgery.

Because the precise target is relatively small, to treat a whole tumor or tumors, the ultrasound is repeatedly and systematically focused to produce many side-by-side lesions, causing complete cell death of the whole tumor volume; this is commonly referred to as coagulative necrosis.

After the procedure, the dead tissue remains corresponding in size to the initial tumor plus an appropriate margin of normal tissue. There is an immediate inflammatory response at the periphery of the ablated tumor, but two weeks after the treatment, the periphery is replaced by repair tissue. Beyond this time, there is a gradual shrinking of the treated regions, which indicate the development of fibrous scar tissue.2

ADVANTAGES & LIMITATIONS OF HIFU
The major advantages of HIFU are that it is not a systemic treatment and it is non-invasive, meaning that there are no incisions through skin or muscle and there are no punctures into the tumor with needles (an injection for anesthesia, however, is sometimes necessary). Compared to surgery, which damages the surrounding tissues and is associated with mortality through complications of the procedure, HIFU only destroys the tumor along with a small margin. Whereas chemotherapy is a systemic treatment, HIFU, like 3D conformal or gamma-knife radiotherapy, is highly targeted. And as opposed to radiotherapy, with HIFU, there tends to be much less damage to normal tissue. Finally, along with the advantages of a highly targeted, non-invasive treatment, HIFU generally only requires one or two sessions at the hospital and is generally compatible with other kinds of treatment.

There are limitations, however. Although HIFU has a high degree of precision, if a tumor lies adjacent to another organ, especially a hollow structure like the bowels or lungs, damage to the adjacent structures may occur, leading to further complications. While HIFU can treat bone cancer, in most cases it cannot treat cancer that lies in soft tissue behind the bone, such as inside the skull. Also, a HIFU procedure could take between one and six hours, during which time the patient must be completely immobile (to ensure accuracy in ablating each side by side segment without leaving gaps of cancerous tissue), which makes local or general anesthesia necessary. Finally, HIFU to the prostate can result in incontinence and impotence, side effects that are similar to prostatectomy.3, 4

SAFETY
In contrast to surgery, HIFU does not increase the potential risk of metastasis.5 The side effects resulting from HIFU are different for each type of cancer treated and compare favorably to the treatment methods currently available. Side effects include mild to moderate pain of typically short duration, superficial skin burns, and transient fever. In addition, rare incidences of infection at the ablation site have been reported.7

WHO IS A GOOD CANDIDATE FOR HIFU?
Uterine Fibroids
HIFU treatment for uterine fibroids is currently available here in the United States. The size, number, and location of fibroids are important criteria to consider. In general, ExAblate 2000 (see "Various HIFU Systems" below) treatment is best for people who can go into an MRI, which excludes people who have metallic implants, claustrophobia, or allergy to contrast agents used to see blood vessels. In particular, submucosal, subserosal, and intramural uterine fibroids may be treated. However, fibroids that are pedunculated (hanging from a stalk) or fibroids adjacent to organs, such as the bladder and bowel, may be untreatable. Additionally, women who are pregnant or desire future pregnancy are not suited for HIFU as its impact on the ability to become pregnant or carry a fetus to term has not been adequately studied.

Prostate Cancer
Good candidates for treatment are patients with localized cancer (Stage T1-T2) who are not candidates for a prostatectomy (because of age, state of general health, or an associated disease) or patients who want an alternative to surgery. If gland volume is larger than 40cc, hormonal therapy to reduce size may be required first. Additionally, this treatment can be used with patients who have local recurrence after external radiotherapy ("salvage" treatment). Patients can choose between the Sonablate 500 and Ablatherm devices (two different types of HIFU machines), and can consider enrolling in Sonablate Phase I or Ablatherm Phase II or Phase III clinical trials in the United States. Patients can also consider traveling to Canada, Mexico, or Europe for treatment.

Liver, Kidney, Bone, Pancreatic, & Breast Cancers
These types of cancer have been treated extensively in China and treatment is just emerging in European countries. Interested patients may investigate options of enrolling in a clinical trial using the ExAblate 2000 device, seeking treatment in Oxford, England, or traveling to a center in Asia, such as in Chongqing, China.

VARIOUS HIFU SYSTEMS
Extracorporeal HIFU for Solid Tumors
The ExAblate 2000 device, made by InSightec of Israel (see "Online Resources" below), is approved by the FDA and is available in the United States for the treatment of uterine fibroids. This device uses magnetic resonance imaging (MRI) to identify lesions and monitor the delivery of focused ultrasound. The ExAblate device is also being used in clinical trials in other countries for bone, liver, and breast cancers, as well as brain lesions without the need for opening the skull; these trials are recruiting patients now (see "Current Clinical Trials" below).

For the treatment of other solid tumors, there are two companies in China that make competing systems. One company is called Haifu, with a important branch based in Chongqing, China. The Chongqing Haifu device has CE approval and has been used to treat thousands of patients in China where treatment is available for foreign patients. This device is also being used in clinical trials in England, Malaysia, Japan, and Korea. Another company is called Shanghai A&S Science and Technology Development Co. Their HIFU system has been tested in China in over 1,000 patients6 for sarcoma and cancers of the liver, bone, breast, kidney, and pancreas.6, 7

Transrectal HIFU for Prostate Cancer
One device is made in the US by Focus Surgery and is called Sonablate 500. Another device is made in France by EDAP and is called Ablatherm. Both are approved in Europe and the FDA has given approval in the United States for Phase I, II, and III clinical trials for prostate cancer. Additionally, the device is currently available for prostate cancer treatment in Mexico, Canada, and Europe.

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ONLINE RESOURCES

General Information: http://en.wikipedia.org/wiki/Hifu
Prostate Cancer Research Institute Review: http://www.prostate-cancer.org/education/novelthr/Chinn_TransrectalHIFU.html
Uterine Fibroids Treatment Center: http://www.uterine-fibroids.org/index.html

HIFU Manufactures
Exablate 2000: http://www.insightec.com
Sonablate 500: http://www.focus-surgery.com
Sonablate 500 International: http://www.internationalhifu.com
Ablatherm: http://www.edap-hifu.com
Ablatherm International: http://www.hifu-planet.com
Haifu: http://www.hifutech.com
Haifu in China: http://www.haifu.com.cn
Haifu in England: http://www.hifucancertreatment.co.uk
Shanghai A&S: http://www.aishen.com.cn/doce/gsjj1.htm

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CURRENT CLINICAL TRIALS (Winter 2006)
EXABLATE® 2000
Patients with pain due to bone metastases for whom other available treatments are neither effective nor feasible.
» Toronto General Hospital. Toronto, Canada.
Debbie Havill. (416) 946-4501 x 4310. debbie.havill@uhn.on.ca

Patients with pain due to bone metastases for whom other available treatments are neither effective nor feasible or
patients with inoperable or unresectable malignant, primary, or metastatic liver tumors.
» Charite Hospital. Berlin, Germany.
Svenia Podlowski. 49 (30) 450-557175.
» St Mary’s NHS Trust. London, England.
Dennis Baker, MD. 44 (20) 7886-6496. drdenzilb@aol.com
» Chaim Sheba Medical Center in Tel Hashomer.
Tel Aviv, Israel. Rafael Catane, MD. 972 (3) 530-2064. catane@sheba.health.gov.il
» Breastopia Namba Hospital. Miyazaki, Japan.
Hidemi Furusawa. 81 (985) 32-7177. furusawa@breastopia.org

Patients with brain lesions.
» University Children’s Hospital. Zurich, Switzerland.
Beat Werner. 41 (44) 266-8123. beat.werner@kispi.unizh.ch

SONABLATE® 500
Phase I Clinical Trial in the United States
Eligibility: Men, 40 to 80 years old, with prostate cancer. No metastatic disease, previous biological therapy or chemotherapy for prostate Cancer, previous transurethral resection of the prostate or prostatectomy, or previous rectal surgery. Must be at least three months since hormone therapy.
» Indiana University Cancer Center. Indianapolis, IN.
Rhoda Loman. (317) 274-1791. rloman@iupui.edu

ABLATHERM® HIFU
Phase II and III Clinical Trials in the United States
Eligibility: Men, at least 50 years old, with prostate cancer. No metastatic disease and no hormonal therapy within last six months. Radiation treatment at least 18 months ago. Disease recurred following radiation treatment.
» Georgetown University Medical Center.
Washington, DC. John Lynch. (202) 784-4000. RXAU@gunet.georgetown.edu
» Baylor University Medical Center. Houston, TX.
Dr. Brian Miles. (713) 798-8514. macdonne@bcm.tmc.edu
» Florida Foundation for Healthcare Research. Ocala, FL.
Ellen Metivier. (352) 237-3949. emetivier@floridahr.com
» Chinn & Chinn Urology Associates. Arcadia, CA.
Eva Chinn. (626) 574-7111. dchinn3@earthlink.net

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QUESTIONS TO ASK A HIFU FACILITY

The following are examples of the sort of questions patients should ask when evaluating foreign HIFU treatment facilities.

What are the clinical specialties of your hospital?
Euromed Clinic in Germany: The Department of Urology is focused on uro-oncology and continence procedures.
University College in London: University College London Hospitals NHS Trust is a tertiary referral centre that covers all medical and surgical specialties.
Capio Springfield Hospital in Chelmsford, UK: All major medical and surgical specialities including urology, oncology, orthopaedics and cosmetic surgery are catered for at the hospital.

How many patients are treated with HIFU technology per year in your hospital?
Germany: Calculating for 2006, we will approach 30 therapies.
London: About two men per week for prostate cancer.
Chelmsford: Currently an average of 4-5 patients per month are treated with this procedure. As you have stated this is a new technology and over time more and more patients have requested information and chosen the Ablatherm HIFU treatment as an option of treatment for their prostate cancer.

What patients are eligible for treatment at your center?
Germany: We treat patients with presumably localized disease only: PSA less than 15ng/ml, Gleason Score less than 7, prostate volume less than 40ml.
London: Men with localized prostate cancer of low-moderate risk or who have refused other treatments. Prostate glands larger than 40ml will need to be placed on hormonal therapy for three months to reduce the size before HIFU. Men who have failed other therapies will be assessed on an individual basis.
Chelmsford: Essex Urology in association with Capio Springfield Hospital has been carrying out HIFU treatments for the past year. The team offers a combined HoLAP/HIFU procedure which enables patients to be discharged the following day usually catheter free. The Essex Urology team at Capio Springfield Hospital carried out the first combined HoLAP/HIFU procedure in the world successfully in October 2005. HoLAP is Holmium ablation of the prostate which is similar to a TURP coring of the prostate to enable the patient to be catheter free much earlier than when under the normal HIFU procedure. Due to swelling of the prostate at the time of standard HIFU procedure catherisation times can normally be as long as three to four weeks. Prostate cancer treatment using the Ablatherm HIFU equipment has been successful in keeping with international data results. HIFU treatment is reserved for patients with localised prostate cancer. Patients undergo an extensive consultation, staging investigations including bone scan and MRI scans to exclude metastatic disease. The procedure itself takes three to four hours and therefore patients must be assessed to ensure that they will tolerate a general anaesthetic for this long.

What patients cannot be treated?
Germany: Huge prostatic calcifications do not allow HIFU for prostate cancer. A missing rectal access (e.g. previous rectal cancer, rectal stricture) also excludes patients from HIFU.
London: Only prostate cancer patients can be treated. No other types of cancer at this time.
Chelmsford: HIFU treatment has been developed specifically for the treatment of prostate cancer. The HIFU technology can be applied to any solid cancer (eg. liver, kidney, etc.). The difficulty to date has been how the energy is delivered to these organs. Current technological research is in the process of developing probes which will be suitable for treatment of these other cancers at some point in the future.

What are the adverse effects from treatment? How many and what kinds of adverse effects have occurred at the hospital?
Germany: So far, we have observed dysuria, pollakisuria, and short-term urinary retention.
London: Urinary tract infection (5 in 100), urethral stricture (narrowing in the urine passage) (1 in 10), retrograde ejaculation (semen going into the bladder rather than out through the penis) (3 in 100), epididymitis (infection of the tubes surrounding the testicles) (3 in 100), urinary retention requiring surgery (2 in 100), impotence (1-2 in 4), urinary incontinence (temporary) (0-2 in 100), and recto-urethral fistula (an abnormal connection between the rectum and urinary passage (0-1 in 200).
Chelmsford: HIFU treatment is considered a non-operative curative therapy for prostate cancer. As such the side effects as compared to other prostate cancer treatments such as radical prostatectomy and radical radiotherapy are much less. Adverse effects include the following:

» Grade I incontinence can affect up to 5.8% of patients. This represents a "dampness" rather true urinary leakage. This compares with radical surgery where rates can be between 5-11% of more obvious urinary leakage.

» Impotence occurs in up to 60% of patients. This figure, again, can be higher in patients undergoing radical surgery or radiotherapy. Such patients are usually responsive to oral measures such as Sildenafil (Viagra).

» Rectal fistula is rare but described with this treatment. It can occur in men undergoing salvage HIFU therapy post radiotherapy.

» Urinary retention can occur as a short-term complication. It is much less of a problem with the combined HoLAP/HIFU procedure.

» To date, there have been no complications of incontinence and post-operative impotence has been avoided or treated successfully with sildenafil (Viagra). There have been no rectal fistulae complications in the patients treated with the combined HoLAP/HIFU at Springfield Hospital.

Who are the doctors in charge of HIFU treatment at the center? What specialty training do your doctors have, and where did they receive training?
Germany: Dr. E. Bismarck and Dr. T. Ebert do these procedures. Dr. Ebert started with this technique in the 1990s and was the first to use this procedure in Germany. He was trained at his site by the company and has since trained others in Germany. Dr. Ebert has treated some 100 patients with the Sonablate device. In May 2004, he was retrained on the latest device (software).
London: The Consultant Urological Surgeon is Mark Emberton, who has a special interest in minimally invasive treatment
of the prostate. He has the UK approved qualifications to practice as an independent medical practitioner.
Chelmsford: Mr Ranjan Thilagarajah MS FRCS FRCS(Urol) is leading the Ablatherm HIFU treatment program at the Capio Springfield Hospital. He trained in Lyon, France under Professor Gelet, who is considered by some to be the "Father of HIFU development".

What is their level of written and spoken English understanding?
Germany: Dr. Ebert has spent two years at Memorial Slone-Kettering in New York as a post-doctorate fellow and still has close relations to many American urologists. English language is not a problem in our department.
London: Dr. Emberton is fully conversant in English and Spanish. He is also able to communicate somewhat in French.
Chelmsford: The team at Essex Urology and Springfield Hospital are native English speakers and were brought up and schooled in the UK

What is the nurse to patient ratio in your hospital?
Germany: Intensive care 1:2, regular urology 1:5.
London: I do not have this information.
Chelmsford: Depends on patient dependency but generally ward acute surgical elective is 1:5/6 days and 1: 8 nights. High Dependency Unit ratio is is 1:2

What accreditation does the hospital have? Do you have United States accreditation?
Germany: We are a private clinic, which is not restricted by any accreditation. I personally have permission to treat members of the US Forces in Germany (TRICARE Europe Preferred Provider).
London: The hospital is a teaching hospital of the National Health Service. It recently was awarded Foundation Trust status by the government, which is a mark of recognition.
Chelmsford: Capio Springfield Hospital is fully accredited by the Healthcare Commission in the UK. We are able to treat all patients within the UK and Europe and some patients are occasionally coming from further a field.

Does the hospital staff have training and or experience working with foreign patients? With American patients?
Germany: Yes, they definitely have experience with both American and other foreign patients.
London: Our group has experience treating American patients in our other trials in Photodynamic therapy of prostate cancer.
Chelmsford: Capio Springfield Hospital regularly treats overseas patients, including from the United States, Middle East, Far East, Greece, and Thailand

What is the cost of treatment (including hospital fees)?
Germany: 12,000 Euros including hospital and doctors.
London: Contact the treatment center for this information.
Chelmsford: Currently, the cost of the combined HoLAP/HIFU treatment is in the region of £16,000. This includes all pre and post care with consultations, hospital fees and the operation itself. Travel packages will be may made available for US patients wishing to be treated that will include a "door-to-door" service if necessary according to requirements. This can be arranged as necessary but is not included in the above estimate.

What type of HIFU system is used at the hospital?
Germany: Sonablate 500.
London: Sonablate 500.
Chelmsford: Ablatherm HIFU.

What are the regulations regarding foreigners receiving treatment?
Germany: No regulations. Payment can be made by credit card.
London: Not sure, but we are fairly flexible as patients would be self-paying.
Chelmsford: Patients will be asked to provide specific medical data prior to be accepted as patients. Patients should expect to be in the UK for about one week in total to ensure that they are safe to travel post treatment. All fees should be paid in advance of any proposed treatment i.e. on booking travel package or on arrival in the UK depending on package chosen.

CONTACT INFORMATION
Euromed Clinic in Germany
Tom Ebert, MD, Chief of Urology
ebert@euro-med-clinic.de
http://www.euromedclinic.de

University College in London
Hashim Uddin Ahmed, MRCS(Ed), BM, BCh (Oxon)
Clinical Research Fellow (Uro-Oncology)
Institute of Urology, University College London
hashim.ahmed@ucl.ac.uk
http://www.ucl.ac.uk/uro-neph/

Capio Springfield Hospital/Broomfield Hospital
Sue King
enquiries@essexurology.co.uk
http://www.essexurology.co.uk

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RECENT STUDIES

Am J Obstet Gynecol 2003;189:48-54.
Patients/Disease: 55 women with fibroids causing significant symptoms.
Technology: MgRFUS.
Effectiveness: They plan to follow the women who did not have a subsequent hysterectomy to see how well the ultrasound treatment reduces fibroid symptoms.
Side Effects: No major complications.
Hospital: Dr. Elizabeth A. Stewart, of Brigham and Women's Hospital, Boston

Obstetrics and Gynecology, November 2004.
Patients/Disease: 76 women with different types of vulvar dystrophy
Technology:
Effectiveness: 49 patients were cured with ultrasound therapy, and 23 more had a good improvement in their condition. Just four women had persistent disease.
Side Effects:
Hospital: Dr. Zhibiao Wang, from the Institute of Ultrasound Engineering in Medicine in Chongqing

Blana, A., S. Rogenhofer, et al. (2006). World J Urol.
Patients/Disease: 223 consecutive patients with localized prostate cancer 174 (78%) patients had one treatment, while 49 (22%) needed a second treatment.
Technology: Ablatherm.
Effectiveness: No improvement in symptom score or quality of life.
Side Effects: After one HIFU (223 patients): urinary tract infection (0.4%), chronic pelvic pain (0.9%), infravesical obstruction (19.7%), stress incontinence (7.6%), impotence (49.8%). After second HIFU (49 patients): incontinence (12.2%; P = 0.024), impotence (55%; P < 0.001).
Hospital: Department of Urology, University of Regensburg, St. Josef Hospital, Landshuterstraße 65, 93053 Regensburg, Germany. Andreas Blana: blana@caritasstjosef.de

Lee, H. M., J. H. Hong, et al. (2006). Prostate Cancer Prostatic Dis.
Patients/Disease: 58 patients with localized prostate cancer with or without transurethral resection of the prostate.
Technology: Ablatherm.
Effectiveness: The success rates of HIFU were 85, 77 and 47% in low-, intermediate- and high-risk groups, respectively.
Side Effects: The operation-related complications were minimal.
Hospital: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Jin, C. B., F. Wu, et al. (2003). Zhonghua Zhong Liu Za Zhi 25(4): 401-3.
Patients/Disease: Fifty patients with unresectable hepatocellular carcinoma.
Technology: HIFU combined with transcatheter arterial chemoembolization (TACE)
Effectiveness: The median survival time, 6-month and 1-year survival rates were 11.3 months, 80.4 - 85.4% and 42.9% in T + H group, in contrast to 4 months, 13.2% and 0% in T group with significant differences (P < 0.01). The average survival time of patients who died was 10.21 +/- 4.12 months in T + H group, as compared with 4.35 +/- 2.39 months in T group also with significant differences (P < 0.01).
Side Effects: Not reported.
Hospital: Clinical Center for Tumor Therapy, Second Hospital, Institute of Ultrasonic Engineering in Medicine, Chongqing Medical University, Chongqing 400010, China.

Li, C. X., G. L. Xu, et al. (2004). World J Gastroenterol 10(15): 2201-4.
Patients/Disease: 100 patients with liver cancer.
Technology: JC type Chongqing HIFU Technology.
Effectiveness: Clinical symptoms relieved 86.6%. Ascites disappeared in 6 patients. ALT and AST were reduced to normal in 83.3% and 72.9% of patients, AFP was lowered by more than 50% in 65.3% of patients. MRI or CT findings indicated coagulation necrosis and blood supply reduction or disappearance of tumor in the target region.
Side Effects: Not reported.
Hospital: Chuan-Xing Li, Department of HIFU, Cancer Center, Sun Yat-sen University, Guangzhou 510060, Guangdong Province, China. lichx@163.net or +86 (20) 8734-3381.

Thuroff, S., C. Chaussy, et al. (2003). J Endourol 17(8): 673-7.
Patients/Disease: 402 Patients presenting with localized (stage T(1-2)N(0-x)M(0)) prostate cancer.
Technology:
Effectiveness: Patients received a mean of 1.4 HIFU sessions. The negative biopsy rate in the T1-2 primary-care population was 87.2%. A 92.1% negative biopsy rate was observed in low-risk patients.
Side Effects:
Hospital: Department of Urology, Munchen-Harlaching Krankenhaus, Munchen, Germany.

Uchida, T., S. Baba, et al. (2005). Hinyokika Kiyo 51(10): 651-8.
Patients/Disease: 72 consecutive patients with stage T1c-2NOM0 prostate cancer.
Technology: Sonablate 500TM HIFU device (Focus Surgery, Indianapolis, USA).
Effectiveness: Biochemical disease-free survival rates in all patients at 1 and 2 years were 78% and 76%, respectively. No viable tumor cells were noted in 68% of patients by postoperative prostate needle biopsy. Prostatic volume was decreased from 24.2 ml to 14.0 ml at 6 months after HIFU (p < 0.01).
Side Effects:
Hospital: The Department of Urology, Tokai University Hachioji Hospital.

Uchida, T., H. Ohkusa, et al. (2006). BJU Int 97(1): 56-61.
Patients/Disease: 63 patients with stage T1c-2bN0M0 localized prostate cancer.
Technology: Sonablate system (Focus Surgery, Inc., Indianapolis, IN, USA).
Effectiveness: The overall biochemical disease-free rate was 75% (47 patients). Final follow-up sextant biopsies showed that 87% of the patients were cancer-free.
Side Effects: Urethral stricture (24%), retrograde ejaculation (3%), epididymitis (3%), TURP for prolonged urinary retention (2%), grade 1 transient incontinence for a month (2%), and recto-urethral fistula (2%). Eight of the 34 patients who were sexually active complained of erectile dysfunction after HIFU; two of these eight who desired treatment were treated with sildenafil citrate, and recovered.
Hospital: University of Tokai Hachioji Hospital, Hachioji, Japan. tuchida@green.ocn.ne.jp

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REFERENCES

1. Kennedy JE, Ter Haar GR, Cranston D. High intensity focused ultrasound: surgery of the future? Br J Radiol. Sep 2003;76(909):590-599.
2. Kennedy JE. Innovation: High-intensity focused ultrasound in the treatment of solid tumours. Nat Rev Cancer. Apr 2005;5(4):321-327.
3. Blana A, Rogenhofer S, Ganzer R, Wild PJ, Wieland WF, Walter B. Morbidity associated with repeated transrectal high-intensity focused ultrasound treatment of localized prostate cancer. World J Urol. Jul 19 2006.
4. Chaussy C, Thuroff S. The status of high-intensity focused ultrasound in the treatment of localized prostate cancer and the impact of a combined resection. Curr Urol Rep. Jun 2003;4(3):248-252.
5. Wu F, Wang ZB, Jin CB, et al. Circulating tumor cells in patients with solid malignancy treated by high-intensity focused ultrasound. Ultrasound Med Biol. Apr 2004;30(4):511-517.
6. Wu F, Wang ZB, Chen WZ, et al. Extracorporeal high intensity focused ultrasound ablation in the treatment of 1038 patients with solid carcinomas in China: an overview. Ultrason Sonochem. May 2004;11(3-4):149-154.
7. Kennedy JE, Wu F, ter Haar GR, et al. High-intensity focused ultrasound for the treatment of liver tumours. Ultrasonics. Apr 2004;42(1-9):931-935.

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