Answers from Leading Urologist Dr. Steven Gange
What is the history of HIFU and how long has it been around?
HIFU research began as far back as the 1950s at Indiana University. However, the first human prostate cancer study was conducted in 1994 by Dr. Marberger and Dr. Madersbacher at the University of Vienna in Austria using the Sonablate® 200 treating 29 human prostates prior to performing a radical prostatectomy. The goal was to see if the energy delivered was enough to destroy the desired tissue. The study found that treatment could be performed safely and could be repeated.
In 1995, a different study, done at Indiana University showed that the entire prostate could be treated without damaging the prostate capsule or the rectal wall. In 1999, Dr. Toyaki Uchida began treating patients using the Sonablate® in Japan. The device received approval for use in Europe with the CE Mark in 2001 and in 2004, treatment became available at hospitals and treatment centers in Mexico, Costa Rica, South Africa and the Caribbean. Health Canada approved the Sonablate® 500 in June 2005 and the first Sonablate® HIFU procedures were performed in Toronto in March 2006.
Currently, there are approximately 500 physicians using HIFU worldwide and over 50,000 total procedures have been completed. SonaCare Medical is the manufacturer of the Sonablate® and received clearance from the FDA for prostate cancer ablation in October 2015.
Does HIFU only treat the cancerous cells?
Sonablate® HIFU will ablate any tissue that the physician targets with the device during treatment planning. After the physician reviews your diagnosis, he or she will make a recommendation on the best course of treatment. This recommendation, based on your pathology report and imaging, will include how much of the prostate should be treated.
In some cases, the entire prostate will be targeted, which would include the tumor as well as any other tissue in the prostate. Think of it as having the prostate removed, without a single incision. However, some physicians, who work with advanced, MRI- guided imaging for diagnosis, can determine the exact location of the tumor in the prostate and may use HIFU to only treat the tumor leaving other tissue in the prostate intact; this is referred to as partial tissue ablation, or focal therapy.
How does Sonablate® HIFU compare to Ablatherm HIFU?
The Sonablate® device allows for a more precise and customized treatment than the Ablatherm. Sonablate® software allows for smaller treatment zones and adjustable energy delivery, which allow for focal treatments and less risk in damaging important structures such as the urinary sphincter and nerves that are important for erections. Additionally, it is possible to treat larger prostate glands with the Sonablate®.
How do I know if I qualify for HIFU?
While only a physician can determine if you qualify for HIFU or not, typically men with a prostate gland of less than 40 grams with localized prostate cancer (tumor has not spread outside of the prostate gland) may be candidates for HIFU. The other information that physicians usually look at to determine if you qualify for HIFU is a PSA of 20 or less and a Gleason score of 7 or less. It is best to talk with a HIFU nurse or doctor to determine if you might qualify for HIFU.
Can I still be treated if I have a large prostate?
Your physician will need to know the exact dimensions of your prostate to know whether or not you are a candidate for HIFU. If your prostate is too large, there may be ways you can work with your doctor to shrink or reduce the size of the gland prior to scheduling a HIFU procedure.
Should I have total gland HIFU or Focal HIFU?
In order to know if you are a candidate for focal HIFU or whole gland ablation, a physician would need to thoroughly review your pathology report as well as ideally have advanced MRI imaging done to determine the exact size and location of your prostate cancer.
Is there a greater chance that the cancer will come back if I choose to have a focal treatment versus full gland treatment?
With focal therapy, the physician only treats the area of the prostate that contains the tumor. This is determined after multiple types of diagnostic imaging as well as biopsy reports to confirm the staging of the disease. The procedure is shorter, recovery time is faster and time wearing a catheter is greatly reduced. This means that if after focal HIFU there is an elevation in PSA and evidence that the cancer has appeared in a different location, the physician can easily go back and deliver HIFU in the new location. Additionally, the patient may choose to have any other type of therapy at that time. This is a much less radical approach to locating the cancer and eliminating it. Prior to having focal HIFU, your physician should thoroughly explain to you the risk of the cancer returning based on your diagnostic reports.
What will I need to do to prepare for the HIFU procedure?
Prior to HIFU, patients usually have lab work (Complete Blood Count (CBC), Complete Medical Panel, Urinary Analysis with culture if indicated by your physician) and an EKG in preparation for undergoing anesthesia. If the patient has any significant medical history, he should see his cardiologist or primary physician. The HIFU procedure itself causes no significant bleeding or swings in blood pressure, etc. A nurse will send detailed information after the procedure has been scheduled regarding diet, medications and any additional lab work or tests that may be required.
How long does the HIFU procedure take?
The length of the procedure depends on the size of the prostate gland. Larger glands will take longer to treat completely. A way to estimate time is 1 hour for every 10 grams of tissue to be treated. That works out to an average of 1-4 hours.
What happens to the urethra during HIFU? Since it runs through the center of the prostate, is it destroyed during the procedure?
During Whole Gland HIFU, the entire prostate is ablated, including the prostatic urethra. However, the urethra is derived from a different type of tissue (bladder squamous-type epithelium) rather than prostatic tissue (glandular, fibrotic and muscular). While the urethra is an important anatomical structure, the sphincter and bladder neck are more important to maintaining the urinary function. However, during Focal HIFU, the urethra is usually spared (not ablated).
Is there pain with HIFU? What should I expect?
During HIFU, patients are given anesthesia to minimize any movement during the procedure and to make the patient as comfortable as possible. There should be no pain associated with the procedure although patients may experience various levels of discomfort afterwards.
What type of anesthesia is used for the HIFU treatment?
General anesthesia is the preferred anesthesia during HIFU procedures. It is very important that you and your prostate remain still for the duration of the procedure, and general anesthesia assures that this happens.
What is the recovery time and the side effects of Sonablate® HIFU?
Your specific recovery will depend on the stage and location of your disease, but in general, recovery involves wearing a catheter; however, most people usually return to most of their normal activities within a few days. Immediately following the HIFU procedure, men spend a few hours in recovery at the treatment facility and then are discharged to return home. HIFU patients sometimes experience frequency, urgency, mild discomfort or discharge in the urinary stream.
What kind of catheter will I have to wear?
Most patients have a suprapubic catheter after HIFU. This is inserted by a physician after the patient is asleep and before HIFU begins and will be in place after the procedure for 1-2 weeks depending on the size of your gland. The catheter allows for your bladder to empty comfortably while your body heals. It is common to have a catheter for some length of time after prostate cancer procedures. If you are having a focal (partial gland) treatment, you may go home with a foley (urethral) catheter which is typically worn between 5-10 days. The type of catheter you have will be determined by your HIFU physician before your treatment and your HIFU nurse will provide you education on how to care for your catheter.
When can I resume sexual intercourse?
Usually, patients can have sex after their catheter has been removed. You should speak with a physician if you have any questions or concerns about resuming sexual activities.
When can I go back to work/normal activities?
Men may return to office based work and drive the following day. More intense physical activity resumes in 3-5 days, though no activity should be started that dislodges the catheter or stirs up bleeding from the catheter insertion site.
What type of follow up is there after HIFU?
Follow up after HIFU with your physician will be similar to any other treatment for prostate cancer. A HIFU nurse will call you after your procedure to see how you are recovering and ask if you have any questions and concerns. Additionally, you will need to make an appointment 1-2 weeks after your procedure to have your catheter removed and then return for visits at 3 months, 6 months, 9 months and 12 months to have your PSA tested.