HIFU Details
Indications
Prostate cancer is an illness that develops slowly. Unfortunately, it develops quietly and most of the time sufferers have no symptoms. It is possible to have the illness for several years without knowing it. Unfortunately, patients sometimes learn of their cancer when it has reached an advanced stage and has already spread throughout their body and away from the prostate as metastases. However, novel techniques for early testing allow for the illness to be detected much sooner so patients can begin treatment with much more favourable prognostics. The indications for Sonablate 500 HIFU are patients who are diagnosed at an early stage with a moderately aggressive cancer.
Therefore, it is widely accepted that the best indications are patients who are suffering from cancer at a maximum of the localized T2c stage, without metastases, with a PSA less than or equal to 10, gleason score less than or equal to 7. Our new screening criteria does allow patients to be placed on the schedule as long as PSA is less than or equal to 20.
Contraindications
There are far fewer contraindications for Sonablate 500 HIFU than for other prostate cancer treatments. In fact, HIFU may be an excellent alternative for a patient who is contra-indicated for traditional surgery due to the presence of risk factors (cardio-vascular illness, excess weight, age, etc.). The contraindications are limited to patients who are suffering from cancer at a more advanced stage than T2c and for whom the illness is no longer confined to the prostate but has already progressed to neighboring structures. However, this contraindication is not linked to any risk to the patient, but rather to a lower healing potential.
HIFU is a therapy that now has 10 years of follow-up. Because it has less follow-up than traditional techniques, it is recommended for older patients who have a life expectancy of 10 to 15 years. Nevertheless, each patient is free to choose their preferred type of treatment. In some instances, younger patients have chosen HIFU because they do not want to undergo complex surgical procedures or lengthy radiation treatments.
Patients who are diabetic can also be treated with HIFU. Anyone who is an insulin dependent diabetic is routinely treated as the first case of the day.
An additional benefit of HIFU is that patients with a cardiac history that would not be a candidate for surgery can still qualify for HIFU. Patients with a history of cardiac problems will be asked to provide a cardiologist consult prior to treatment. Each patient’s history is assessed by our anesthesiologist on a case by case basis. All patients need to forward blood work and an electrocardiogram in advance of treatment.
HIFU is currently under clinical trials by the United States Food & Drug Administration (FDA). FDA requires that clinical trials be performed in the US, whereas Canada accepted the European clinical trial data. After many years of development and testing, HIFU was approved throughout the European Union in 2000 and in Canada in March 2003.
HIFU was first used to treat prostate cancer in approximately 1997. There have been many improvements in the technology since that time which took an already safe treatment and made it safer. Since 2002 the statistics indicate that cure rates showing negative biopsy is 93% and 87% showing constant PSA of less than 1 in a study of 146 men treated in Regensburg, Germany. HIFU’s ten year data was recently released in Berlin and was presented to the AUA in June of 2009. It will be available for circulation in the near future.
As a recent treatment, it has less than 10 years’ follow-up, which means that it is intended for patients who have an average life expectancy of 10 years and are therefore aged 70 or over. There is no contraindication for treating younger patients, but the scientific community, unless the patient\'s opinion is different, prefers to recommend adopting the precaution principle.
The cost of the procedure is typically covered by the patient. While there have been no instances of pre-approvals granted for HIFU, we are aware of a number of insurance companies that have provided reimbursement for the procedure. We will be pleased to provide you with documentation to assist you as you attempt to claim benefits.
US patients are able to deduct medical expenses that exceed 7.5% of their adjusted gross income. Details can be found at www.irs.gov/taxtopics/tc502.html.
Patients who are interested in Sonablate 500 HIFU should call toll free 1-877-231-1444. You can also complete the “contact us” portion of this site. One of the nurses will telephone you to begin the process to determine if you are a candidate. Urology Team will assist you to collect all the necessary patient information. A consultation with Dr. Richard Chopp can be scheduled to answer questions and/or concerns. Treatment can generally be arranged within two to three weeks. Patients will be sent a consent package detailing everything that is needed to proceed with treatment.
What is the preparation for HIFU?
7-10 days prior to treatment: All blood thinners including low dose aspirin must be discontinued seven to ten days prior to treatment due to the spinal anesthetic. In certain situations additional blood work is required prior to treatment. Each case must be assessed individually. All of the following medications need to be stopped.
- Aspirin including baby aspirin
- Plavix (Clopidogrel)
- Coumadin (Warfarin)
- Ticlid (Ticlopidine)
Certain herbal products and vitamins can also have blood thinning components so it is a good idea to discontinue these products as well.
On the day before the procedure you will have to take a bowel preparation at home. You may have a light breakfast and then commence on clear fluids for the rest of the day. You are allowed to drink water until 2 hours before admission.
You will be admitted to hospital on the morning of the HIFU. You will be given an enema on admission and any necessary blood tests, ECG or x-rays will be undertaken.
On the day of your arrival you will be seen by one of the treating urologists, one of the anesthesiology staff and the nurse coordinating your treatment plan. This takes about one and a half hours. You will then return to your hotel. On the day of treatment you will come to the hospital one hour in advance of treatment
How is the HIFU performed?
You will be given a general anesthetic. An ultrasound probe is placed in the rectum and the prostate is imaged.
The ultrasound probe is then used to focus high-intensity sound waves on a particular area of the prostate, causing heat in the tissues. (The treatment time ranges from two to two and a half hours depending on the size of your prostate. The urologist will map an outline of the prostate using ultrasound to determine the areas to be treated. 400 to 600 pulses of high intensity, focused ultrasound are then administered to the prostate. On average you will be in surgery for between 2-4 hours.)
This heat causes prostate tissue death.
The process is repeated over the whole area of prostatic tumor until all the cancerous tissue has been destroyed.
A trans-urethral or supra-pubic catheter is left in place following the procedure for drainage of urine. This is because there will be swelling in the area which will impede your ability to pass urine. The catheter remains in for 3-14 days.
What happens after the treatment?
Usually you will be discharged home later on the same day as the HIFU treatment.
Treatment takes approximately two hours with recovery lasting another three to four hours. Patients will spend six to seven hours at the hospital on the day of treatment and will be discharged into the care of a family member or friend to return to the hotel. The following day your urologist will call you at the hotel early in the day before you travel home.
You may eat and drink as soon as you are awake and will be encouraged to walk.
Patients are given pain medication while in the hospital based upon the amount of discomfort they are experiencing. Usually Tylenol with codeine is adequate. On a few occasions something a little stronger may be ordered. A prescription for pain medications is provided for use after discharge. Some patients report that they did not require any medication while others do take some medication for a few days after treatment.
You will be required to be on an antibiotic during the time you have a catheter as there is a risk that the catheter can cause a urinary tract infection.
About 60% of patients experience no trouble and will pass urine with a good flow, good control, low frequency and no incontinence within a few days of having the catheter removed. You will be provided with a prescription to reduce spasm which may occur for a short time after treatment. Sitting in a tub of warm water is also helpful for any pelvic cramping. Another medication, Flomax, is to start a few days prior to having your catheter removed to assist with voiding.
After the HIFU treatment, the destroyed prostate tissue is passed in the urine. It is common to see this sloughed material in the catheter bag. It has been described as looking like “wet tissue paper” or “cotton candy. ” You may see blood in the urine up to 12 weeks post treatment. This can be dark brown in color or a bright red color. This is a normal part of the healing process. The catheter can be removed by the patient’s physician in his home town.
Incontinence
Urinary incontinence is classified as grade 1, 2, or 3, depending on the severity of the incontinence. Grade 1 is minimal stress incontinence which occurs only occasionally and occurs with severe straining. Grade 3 is severe or complete incontinence. After HIFU, Grade 1 incontinence occurs in less than 5% of cases. Grade 2 and 3 incontinence are very rare after HIFU occurring in less than 1% of cases performed as the primary treatment for prostate cancer. After failed radiation therapy or failed brachytherapy (radioactive seeds) up to 8% of patients will have Type 3 incontinence following salvage therapy with HIFU. These rates for treatment of primary prostate cancer and for treatment after failed radiation therapy and failed brachytherapy are both considerably better than for treatment with surgery or cryotherapy.
Incontinence can be of several types. There can be mild incontinence for a few days when a catheter is removed or small amounts of urine can be lost as a result of stressful activities which increase abdominal pressure such as heavy lifting. This type of incontinence (Type 1) is usually time limited and can be eliminated by pelvic muscle exercises known as Kegel exercises. This is not uncommon with HIFU but is not a serious long term problem. More severe incontinence (Types 2 and 3) which requires long term use of incontinence pads and may be found after surgery or radiation treatment is very rarely a problem with primary treatment with HIFU.
Impotency
Injury to the neurovascular bundle can largely be prevented by a nerve sparing treatment procedure. Like other treatments including surgery this is not 100% certain but results are as good as nerve sparing surgery and better than with other treatment modalities. Many patients experience temporary erectile difficulties and it is not possible to predict what the final result might be for several months post treatment. The use of pharmaceutical agents at any time can assist with the quality of erectile function.
Injured nerves may regenerate over time but several months, perhaps up to one year, are required before outcomes can be assessed. The literature now suggests that Viagra, Levitra, Cialis etc, assists with healing by increasing blood flow to the area. You may wish to start taking these medications twice a week once your catheter is removed to assist with the quality of erectile function.
Ultrasound imaging allows visualization of the neurovascular bundles (blood vessels and nerves) which run immediately adjacent to the prostate. The nerves in these bundles are what control erections. Precise localization of these bundles allows treatment to within 2 to 3 mm of them. This technique is designed to preserve potency with still a high probability of eliminating all cancer. The nerve sparing procedure is done only on prostates which have biopsies that are negative for cancer in the lobe of the gland where the nerve sparing procedure is performed. Only one neurovascular bundle needs to be preserved.
Dr. Richard Chopp is one of only a handful of physicians in the United States trained to perform the High Intensity Focused Ultrasound (HIFU) treatment for prostate cancer.
In most cases, HIFU is a 1 to 4 hour, one-time procedure performed on an out-patient basis under spinal anesthesia. Unlike radiation, HIFU is non-ionizing, indicating that it may also be used as a salvage technique if other prostate cancer treatments fail. To date, results have demonstrated that the control rate of prostate cancer using HIFU appears to be equivalent to that of radiation therapy and radical prostatectomy. Patients with low volume disease and less aggressive types of prostate cancer seem to do best across the board, regardless of treatment type.
Those patients treated with HIFU appear to have superior quality of life issues. The incidence of incontinence is less than 5% and the incidence of impotence appears to be less than 10%. These are very important issues for most men with early, newly-diagnosed prostate cancer.
HIFU has been performed in Japan and Europe for many years but has not yet received FDA approval for use in the US. The surgery remains investigational and is being studied for the treatment of prostate cancer in clinical trials in the U.S. Currently, the device is approved for the treatment of prostate cancer in Canada and the Dominican Republic, authorized in Argentina, and available in the Bahamas and Mexico and Dr. Chopp’s patients are treated at Galenia Hospital in Cancun, Mexico. To date, all patients he has treated are from Texas and easy access and proximity to Cancun makes this the location of choice for the HIFU surgery.
For even more information about HIFU, visit the International HIFU Center site.