Frequently Asked Questions about Prostate Cancer and HIFU

Note: For answers to any health-related questions as they may specifically apply to you, please consult with your treating urologist or other physician. The answers below should only be used as general, illustrative information.

QUESTIONS&ANSWERS

1. Where does the procedure take place?

Maple Leaf HIFUs procedures takes place at the Cleveland Clinic Canada. Cleveland Clinic Canada, the Canadian location of the Cleveland Clinic, is an outpatient facility that specializes in disease prevention, early detection and sports medicine. The clinic overlooks downtown Toronto from the 30th floor of Brookfield Place at 181 Bay Street. See http://my.clevelandclinic.org/canada for further information about the treatment facility.

2. How long will I be in the hospital?

There is no overnight stay associated with the Maple Leaf HIFU treatment. Maple Leaf HIFU is an out patient procedure which adds to its appeal. You are required to travel with someone as the treatment is completed with intravenous sedation and you will be returning to your hotel after your recovery. You are required to be in Toronto for two nights, so we provide deluxe hotel accommodations for you and a travel companion.
On the day prior to your treatment you will be seen by your treating urologist and the nurse coordinating your treatment plan. The nurse will provide you with an enema to be used the morning of your treatment.  This appointment is about one-half hour. There are no dietary restrictions until midnight the day prior to treatment.  Your anesthesiologist will contact you in advance of your treatment to address any questions that you may have.
On the day of treatment, you will come to the clinic one hour in advance of treatment. The treatment takes approximately two hours with recovery lasting another three to four hours. You will spend six to seven hours at the clinic 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 to address any concerns you may have.

3. How long until I can have the procedure?

Patients who are interested in Maple Leaf HIFU should call toll free 1-877-370-4438. 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. Maple Leaf HIFU will assist you to collect all the necessary patient information. During this time one of the urologists will contact you 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.

4. How long does the procedure take? 

The treatment time ranges from two to two and a half hours depending on the size of your prostate. Your 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.

5. I am diabetic. Is that a problem?

Patients who are diabetic can be treated by Maple Leaf HIFU. Anyone who is an insulin dependent diabetic is routinely treated as the first case of the day.

6. I have a cardiac history? Can I still have HIFU?

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 recent 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. Your anesthesiologist will call you prior to your treatment.

7. I’m taking hormone therapy. Do I still qualify?

Yes, you still qualify. Hormone therapy is not a contraindication to HIFU.

8. What happens if I have an enlarged prostate?

Some patients with large prostates, i.e. greater than 40 cc (or grams), or those with significant voiding issues may require drug therapy treatment for 20 days prior to treatment. The size of the prostate is measured by ultrasound at the time of the biopsy. 

Reducing the size of an enlarged prostate by medication allows for the entire gland to be included. It also results in less tissue being present during the procedure. With a smaller prostate, there is less swelling and edema with less likelihood of urine retention post catheter removal.

9. Are there any medications that I should avoid prior to treatment?

All blood thinners including low dose aspirin, vitamins and herbal products 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 will be assessed individually.
All of the following medications need to be stopped with consultation with your physician.
1) Aspirin including baby aspirin 
2) Plavix (Clopidogrel)
3) Coumadin (Warfarin)
4) Ticlid (Ticlopidine)
Certain herbal products and vitamins can also have blood thinning components so it is necessary to discontinue these products as well seven to ten days prior to treatment.

10. What type of pain medication will I require following treatment?

You are given pain medication while in the recovery room based upon the amount of discomfort you may experience. 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.
Sitting in a tub of warm water is also helpful for any rectal discomfort or pelvic cramping.

11. Will I require other medication after treatment?

Yes, you will be required to take an antibiotic during the time you have a catheter as there is a risk that the catheter can cause a urinary tract infection. In addition, you will be provided with a prescription to eliminate any spasm which can occur for a short time after treatment because of the catheter. Sitting in a tub of warm water is also helpful for any pelvic cramping.  Please do not take this medication after the catheter is removed.  Another medication, Flomax, is ordered to begin 2 days prior to having your catheter removed to assist with voiding.

12. Is the procedure done with an anesthetic?

The procedure is completed with intravenous sedation which allows you to sleep throughout the treatment. You will not remember any part of your treatment. For this reason, you are required to be accompanied by someone after treatment.
In addition, you are given a spinal anesthetic which is required so you are comfortable and still through the two-hour treatment. This is very important. When the machine detects any movement, treatment stops immediately. This is one of the safety mechanisms offered with Ablatherm HIFU as programming and treatment are very precise.

13. The rectal probe looks much larger than the standard biopsy/ultrasound probe. Is that why the spinal is required?

Actually, the probe is not much larger. The procedure is completed under spinal anesthesia which is required so you are comfortable and still through the two-hour treatment. This is very important. When the machine detects any movement, treatment stops immediately. This is one of the many safety mechanisms offered with Ablatherm HIFU as programming and treatment are very precise. Another safety feature is that the treatment probe is constantly measuring the distance between the treatment probe and the rectal wall.  In addition, the rectal temperature is measured throughout.  If there is any elevation in temperature the machine will not allow the treatment to proceed.  This is to prevent any rectal injury.

14. I understand that I must wear a catheter after treatment. How long will I have to wear a catheter?

A catheter must be worn for 14 days following treatment as there will be swelling and edema of the treated prostate. The catheter drains the urine from the bladder until the swelling of the prostate subsides. 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 for 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 your physician in your home town.

15. Is there any possibility that I will need to wear my catheter longer than 14 days?

That is very uncommon but possible. This is more likely with men with larger prostates. Unfortunately, this cannot always be predicted in advance and catheter reinsertion is sometimes required. If the catheter is reinserted it should be left in place several days. It is important to take bladder neck relaxing medication (Flomax) prior to catheter removal which is prescribed at the time of treatment.

16. How will I know when to have my catheter removed?

The appropriate timeframe for having the catheter removed is not an exact science however in our experience 14 days is the appropriate length of time. On occasion patients have had to have their catheter reinserted after removal. Unfortunately, this can seldom be predicted in advance as noted above.

17. Can I travel with my catheter?

Yes, most of our patients travel to have their treatment. While you will be able to drive with the catheter you will not be able to drive the day of treatment due to your anesthetic. The catheter may be a little uncomfortable for the first day or two while driving. Sitting as a passenger is not a problem.

18. Will there be a change in my stream after HIFU?

After HIFU there is edema or swelling of the prostate which is why you need the catheter. Occasionally there may be some retained tissue which can lead to a reduced stream which can persist over several weeks. Occasionally if the stream continues to be of a reduced nature further investigation and treatment may be necessary due to ongoing sloughing of the prostate tissue. An outpatient cystoscopy may need to be done by your urologist to flush any remaining tissue.  This is very uncommon.

19. What are the chances (%) of urinary 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. It is a time limited and can be eliminated by pelvic muscle exercises known as Kegel exercises. Grade 3 is severe or complete incontinence. After HIFU, Grade 1 incontinence occurs in less than 5% of cases in the first 3 months. Grade 2 and 3 incontinence is very rare after HIFU occurring in 2% of cases performed as the primary treatment for prostate cancer. These rates are considerably better than for treatment with surgery or radiation.

20. What types of activity can cause leakage?

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.

21. What are the chances (%) of impotence?

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.

22. Approximately how long will it take for the damaged nerves to repair themselves and return my erectile function? I was told that they would come back and that I may need Viagra or Cialis for a while.

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.

23. How does the nerve sparing procedure work?

Ultrasound imaging allows visualization of the neurovascular bundles (blood vessels and nerves) which run immediately adjacent to the prostate. The nerves in these bundles 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.

24. If I were to have HIFU with a nerve sparing procedure and there was a recurrence, is it possible to have a radical prostatectomy with a nerve sparing procedure?

If there is a recurrence, HIFU would be the ideal treatment option. Surgery would be possible, but it would be more difficult. As a general rule of thumb, any time you combine treatment you lower the possibility of sparing the nerves. If the tumor recurs after HIFU it is possible to try to save the nerves but there is a significant chance that it would not be successful.

25. In the biopsy report it was mentioned that there is perineural invasion. Does this affect the HIFU procedure and nerve sparing?

Pathologists often report “perineural invasion” but this carries no prognostic significance and refers to small nerve fibers within the prostate. A tumor around these nerves is an indicator that there is a malignant cancer in the prostate. The presence of cancer cells in the "perineural space" is one of the factors used in making the diagnosis of prostate cancer. This does not indicate that the cancer has spread outside of the prostate but it does suggest that the cancer has been present for a longer period of time. This would not affect HIFU.
These nerves have nothing to do with erectile function so it does not interfere with the nerve sparing technique. The main nerves for erections are outside of the prostate in the neurovascular bundles.

26. What happens to the prostate after the procedure?

Ablatherm HIFU treatment completely destroys the prostate tissue and cancer cells reducing them to protein debris and non-viable tissue. Most of this tissue is sloughed through the urinary tract while some is re-absorbed by the body’s natural mechanisms of dealing with injured or non-viable tissue.

27. Do some patients require repeat treatment?

Every treatment, surgery, radiation or HIFU, has a recurrence rate. There is no medical treatment that is 100% guaranteed. The benefit of HIFU, unlike any other treatment, is that it does not limit future options. Should cancer recur, HIFU can be repeated or you have the choice of surgery or radiation. Surgery and radiation cannot be repeated.

28. Is there a chance that the cancer could return at some point after treatment?

There is a small probability of recurrence as there is with any treatment modality. The benefit of HIFU is that the area could then be retreated.

29. Will I need to have a repeat biopsy and if I do, what do you biopsy if the prostate is no longer there?

Biopsies are only done if the PSA continues to be elevated or rise persistently. A repeat transrectal ultrasound (TRUS) will be required to visualize any remaining or recurrent prostate cancer and a biopsy of the tissue will be performed. The biopsy is conducted on the scar tissue that is left behind. Negative biopsies indicate that cancer is no longer present in the prostate.

30. What is a normal PSA?

Each PSA assay technique lists an expected "normal" value. Usually it is about 4.0 ng/ml. There is at least one nomogram that suggests that this level is not always the same and can rise with age. There is more and more evidence that suggests that there is no safe or normal level and prostate cancer can exist in patients with values significantly less than 4.0.
What is more important is the rate of increase (velocity) of PSA year after year or the rate at which velocity is increasing (acceleration). A rate of increase greater than 0.75 per year should trigger a biopsy. There are multiple other factors as well including prostate volume, presence of inflammatory disease (prostatitis) that can elevate the PSA.

31. How much experience do you have with the technology?

Treatments in Canada began at Maple Leaf HIFU in April 2005. All our urologists are certified in HIFU technology. Training took place in Germany and onsite in Toronto with the German and French teams participating in mentoring. Worldwide, greater than 40,000 men have been treated with Ablatherm HIFU with this number increasing weekly.

32. Do you have recent statistics regarding success rates and side effects?

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. Ablatherm HIFU's fifteen-year data was released in 2011 and can be reviewed here.

Prior to 2002 there was a small risk of rectal injury. Since the parameters of the technology changed in 2002 less than 0.1% of rectal fistula have been reported using Ablatherm(R) HIFU technology. Additional peer reviewed journal articles can be found here.

33. My doctor tells me that HIFU is “experimental”. I thought it had been use for over 15 years.

HIFU is relatively new to the United States having received FDA approval in November 2015 so some physicians may not be aware the benefit of the non-invasive approach to treating prostate cancer.
In April 2003, Health Canada, which is equivalent to the FDA in the United States, approved Ablatherm HIFU to be a safe and effective method of treating prostate cancer. Ablatherm HIFU has also been approved by the European Union and many other countries including Great Britain. The FDA approved HIFU in November 2015. Tens of thousands of treatments have been performed worldwide and the results have been published in peer reviewed medical journals. View our research section of our site for our published results.

34. Will my insurance cover the cost?

The cost of the procedure is typically covered by the patient. While there have been no instances of pre-approval granted for HIFU, we are aware of several 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. More detailed information can be found here . Canadian and American patients can defray some of the cost of treatment when filing their annual tax returns.

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