What is HIFU?
HIFU ( High Intensity Focused Ultrasound) is a non-invasive treatment that kills prostate tissue in the body with powerful precision focused sound waves. The Sonablate and Ablatherm HIFU devices were FDA approved for prostate tissue ablation in the United States in 2015. Please note these are the only approved HIFU treatment devices in the United States.
HIFU is a revolutionary high tech approach to treating prostate cancer non-invasively. The technology has been under development for 30 years and was first used in Europe to treat prostate cancer in 1995. It has been approved for use in Europe, Asia, Mexico and the Caribbean for many years and has been available in the United States since October 2015. HIFU was incorporated into the EAU (European Urology Association) guidelines for salvage (post radiation failure) treatment of prostate cancer, but most American urologists have little experience with this treatment.
HIFU works by delivering high intensity, focused ultrasound waves into the prostate through a rectal transducer. Advanced 3D ultrasound imaging is used to robotically control the delivery of the focused ultrasound waves into the prostate gland so that the targeted prostate tissue can be destroyed. The highly focused, precise ultrasound beam can avoid neighboring critical structures such as the bladder, rectum, external urinary sphincter and neurovascular bundles (that control erectile function). The HIFU procedure is performed under anesthesia in the outpatient setting. Patients require catheter drainage of the bladder for approximately 1 week, but recovery is rapid since there are no incisions to heal. (HIFU video animation)
Significant technological improvements have been made in HIFU technology over the past several years. These improvements include rectal wall cooling, improved imaging, treatment planning and targeting, and Doppler identification of the neurovascular bundles to facilitate nerve sparing. The current HIFU technology allows the experienced surgeon to confirm prostate tissue destruction in real time as the procedure is being performed. MRI images can now be fused or merged with ultrasound images in the HIFU treatment screen allowing for precise MRI image guided prostate ablation. Dr. Scionti has been heavily involved in these refinements and has pioneered treatment techniques designed to lower the risk of side effects such as scar tissue formation or stricture disease. The Scionti MMM (Triple M) HIFU technique is the culmination of over a decade of HIFU experience in over 1000 patients and allows for MRI Mapping of the tumor onto the HIFU ultrasound image and energy Modulation to assure more effective tumor ablation with less side effects.
Like other ablative treatments, HIFU can be used as a total gland treatment, salvage (post radiation failure) treatment and as a focal treatment. Preliminary studies from Europe and Japan suggest that men with low and moderate risk disease achieve excellent biochemical disease free rates, and excellent negative biopsy rates with low rates of incontinence and good preservation of erectile function.
Dr Scionti is recognized as a world leader in the HIFU arena and is currently treating patients in Sarasota Florida at the Vituro Health Sarasota HIFU Center at Lakewood Ranch Medical Center. With over 1500 successful procedures performed, Dr. Scionti has led the way in the training of American Urologists through national training courses and has been a guest lecturer at numerous academic conferences.
In summary: HIFU is a revolutionary non-invasive treatment that kills prostate tissue with focused sound waves. Currently, men with organ confined prostate cancer can elect to have total gland or targeted focal HIFU performed by Dr. Scionti at the Vituro Health Sarasota HIFU Treatment Center. The Scionti MMM ( Triple M ) HIFU technique is only available through Dr. Scionti in Sarasota.
NOTE: The new Medicare C code is a temporary tracking code that provides Medicare reimbursement for the outpatient hospital fess associated with HIFU treatment. Medicare has paid for the hospital fees in all of our Medicare patients treated over the past year. Although most commercial insurance plans such as Blue Cross, United, Aetna, and Cigna do not provide coverage for HIFU treatment, some of our patients have been able to recover a portion of their costs by filing an appeal with their insurance company with the help of the Vituro Health Insurance Reimbursement Assistance Program. Recently, Cigna has authorized coverage for HIFU treatment for men who have a recurrence after radiation therapy. (Salvage HIFU treatment). The VA system has also authorized HIFU treatment on a case by case basis for veterans exposed to Agent Orange.
Is HIFU Effective?
Dr. Uchida from Japan recently published his results from the latest generation Sonablate HIFU device using advanced treatment protocols and Tissue Change Monitoring software. (The Journal of Urology (2014), doi: 10.1016/j.juro.2014.07.096). In this series of 918 patients, the overall 10 year prostate cancer specific survival rate was 97.4%. In the group of 271patients treated with latest generation of Sonablate software, the 5-year biochemical disease free survival rate (PSA control rate) was 95% in low risk patients, 81% in intermediate risk patients and 72% in high risk patients. 93.9% of the 196 patients who had a biopsy after HIFU had no evidence of cancer on their biopsy. These results are similar to outcomes from standard prostate cancer treatments, and it is the opinion of the Scionti Prostate Center that HIFU is an effective alternative to surgery and radiation therapy, and that long-term studies will ultimately validate this opinion.
Studies from Europe and Japan also document the effectiveness of HIFU for radiation failure patients. On October 9, 2014, the FDA granted regulatory approval for Sonablate HIFU to be used for prostate ablation in the USA.
Exciting preliminary work out of London suggests that focal or targeted HIFU results in a very high rate of potency preservation and no urinary incontinence. In a series of 42 patients treated with focal HIFU targeted to tumors in the prostate, as identified by MRI and advanced biopsy techniques, 92% of men were free from clinically significant prostate cancer at 1 year. 90% of men retained erections sufficient for penetration and 100% were dry (no need for protective pads). (Ahmed et al. thelancetoncology. Vol. 13, June 2012.) Longer-term studies are underway to evaluate the long-term effectiveness rates.
Dr. Scionti offers MRI guided targeted HIFU to men with focal or regional prostate cancer. Dr. Scionti has taken a leading role in studying the outcomes of HIFU, compiling our results in total gland procedures outside of the U.S. and as part of the FDA HIFU salvage trial at NYU. As part of the Scionti Prostate Center focal HIFU program, Dr. Scionti is actively offering d focal HIFU to selected patients at Vituro Sarasota Prostate Cancer HIFU Center in Sarasota, Florida
Am I a Candidate for HIFU?
HIFU is effective in treating localized prostate cancer. In cases of recurrence after radiation therapy, HIFU can be employed as a secondary (salvage) treatment if the recurrence is diagnosed early and there is no spread of cancer outside of the prostate.
In general, the best candidates for HIFU have early, localized prostate cancer, a relatively small prostate, and desire a less invasive treatment that has a low risk of urinary leakage and impotence.
Several factors are important to determine if you are a good candidate for HIFU treatment.
The following factors are considered in determining candidacy for HIFU:
- Overall Health
- PSA at diagnosis
- Most recent PSA
- Gleason Score
- Number of cores positive on prostate biopsy
- Prostate volume and dimensions
- MRI findings: (see Scionti Advanced HIFU Protocol)
To find out if you are a good candidate for HIFU treatment,
Click here: AM I a Good Candidate for HIFU?
Questions to Ask Your HIFU Doctor
- Is your doctor experienced in determining HIFU candidacy?
Several factors determine appropriateness for HIFU. Men who are excellent candidates are very likely to have an excellent result. The prostate cancer stage, Gleason Score, extent and location of cancer, prostate size, volume, and height are ALL critical factors. Extensive calcium deposits can block the ultrasound beam and can make HIFU impossible. Only an experienced HIFU surgeon can best assess your candidacy in detail.
- Is your HIFU doctor Certified by the American Board of Urology?
The American Board of Urology is the only entity in America that confers Board Certification in the specialty of Urology. Most American urologists are certified by the American Board of Urology. While this rigorous certification process does not guarantee HIFU competency, it does assure that the urologist has passed extensive examinations, has submitted a practice “log” and had his patterns of urologic care reviewed every 10 years. Board Certification is required by virtually all American hospitals in the granting of staff privileges to a physician. Be aware that Urologists who are not Board Certified often do not have staff privileges at local hospitals and may not be able to offer appropriate post HIFU care.
- How many HIFU procedures has your doctor performed?
While there is no magic number to assure competence, HIFU is a complex and technically demanding procedure. Studies from Europe have demonstrated that highly experienced physicians obtain better results. It is important to note that highly experienced proctors often support physicians in the early stage of their HIFU careers in order to ensure that the patient has a good result. Ask your doctor about his experience level and whether he/she is still being proctored as part of training. Remember that physician experience is the most important variable in HIFU success.
- Does your doctor claim to diagnose prostate cancer by MRI without a needle biopsy?
There is uniform consensus among HIFU surgeons that the only way to assure that a man has prostate cancer and whether the cancer is appropriate for HIFU treatment is by having a diagnostic biopsy performed. The Scionti Prostate Center utilizes MRI Guided Fusion or SMART biopsy technology. We do not suggest blind, random, prostate biopsy. This process documents the presence of cancer, and reveals if the Gleason score and extent of disease can be well treated with HIFU. While a handful of U.S. physicians have claimed they can diagnose and treat patients without a biopsy, even the best MRI scans on 3T MRI machines simply do not provide the physical evidence needed for a treatment decision. While HIFU is noninvasive and the side effects are low, it makes no clinical or economic sense (nor is it ethical) to perform a procedure unnecessarily. Be aware of physicians who market their own MRI services and present their own “results” that have never been published in peer reviewed journals or admitted as podium presentations before peers.
- Can your doctor provide the right level of care after HIFU?
Post HIFU care and counseling is an important part of the recovery process and essential for obtaining a good result. Even though HIFU is non invasive, the prostate gland has been destroyed by the treatment and recovery is required. Counseling directly face to face, by phone or by email with your HIFU physician will guide you through the recovery process results in a faster return to normal voiding, and a lower risk of complications. You will require a local physician who can remove your catheter when you are cleared by your HIFU physician for catheter removal. Uncommonly, there are conditions after HIFU that require treatment by your HIFU physician at a hospital or outpatient surgery center. Be sure to ask your HIFU physician if he/she has staff privileges at these facilities so that you can receive appropriate care. Avoid HIFU physicians who cannot offer you excellent post procedural care and who do not have hospital privileges in the United States.
- What HIFU machine does your doctor use?
There are no head to head comparisons of these machines. The Ablatherm was the first to be used for prostate cancer in France in 1995, while the Sonablate was first used in Japan in 1999. There is more published data on Ablatherm procedures. Both machines have undergone significant technical improvements over the years, but the Sonablate 500 has significant technical advantages in the hands of an experienced HIFU surgeon. These are: the ability to modulate power to achieve appropriate tissue response, the ability to measure tissue response (Tissue Change Monitoring), better ability to conform or match the treatment to individual prostate anatomy, 3D coronal plane imaging, and Doppler technology to assist in mapping the location of the neurovascular bundles. It is my opinion that the Sonablate offers an experienced HIFU physician an enhanced ability to customize the treatment for an individual patient’s cancer and prostate anatomy.
- Does your doctor follow the Scionti MMM ( Triple M ) HIFU Protocol?
Dr. Scionti has combined his skills and experience in treating over 1000 HIFU patients along with his unique highly defined HIFU techniques to develop the Scionti MMM ( triple M ) HIFU Treatment. The Scionti MMM HIFU Treatment utilizes MRI Mapping and energy Modulation to deliver a higher dose of energy to the most significant region of cancer in the prostate, while minimizing energy to the surrounding tissues. Advanced diagnostic MRI evaluation and planning, precise MMM ( triple M ) HIFU treatment, and in-person or virtual long term follow and monitoring are the hallmarks of the Scionti Prostate Center HIFU program.
There are a number of common options for prostate cancer. Each has its own risks and benefits. Primarily patients can choose between Active Surveillance (AS), Radical Prostatectomy (RP, open or robotic surgical prostate removal), Radiation Therapy (IMRT, Cyberknife, Proton, Brachytherapy or seed implant), Cryotherapy, or HIFU. Please take the time to learn about all of the options.
Research on HIFU actually began in the 1950s at Indiana University. In 1994, the first human prostate cancer study was done by Drs. Marberger and Madersbacher at the Univ. of Vienna in Austria using the Sonablate® 200 treating 29 human prostates shortly before performing a radical prostatectomy. The goal was to see if the energy delivered was enough to destroy the prostate tissue. The study found that treatment could be performed safely and could be repeated. In 1995, a study done at Indiana University showed that the whole prostate could be treated without damaging the prostate capsule or the rectal wall. In 1999, Dr Uchida began treating patients using the Sonablate® 200. In 2001, the Sonablate® 500 received the CE mark from Europe and the first patient in the study was treated at Indiana University by Dr. M. Koch. Currently, Sonacare Medical, the manufacturer of the Sonablate technology, sponsored an FDA trial to test the effectiveness and safety of the Sonablate HIFU device in treating patients who have failed radiation therapy. The FDA approved The Sonablate device on October 9, 2015 for prostate tissue ablation. HIFU is available worldwide and has recently been added to the Prostate cancer Treatment Guidelines by the European Urology Association. HIFU treatment is now offered in Sarasota, Florida at the Vituro Health HIFU Center of Excellence.
The Sonablate HIFU device received denovo 510K regulatory approval from the FDA on October 9, 2015 for prostate tissue ablation. This means that HIFU can be used in the USA to ablate prostate tissues. Dr Scionti has extensive experience with using the Sonablate device internationally to treat prostate cancer and offers HIFU ablation to well selected Prostate cancer patients.
The Gastroenterology and Urology Device Panel of the FDA met on July 30, 2014 and made a negative recommendation on the EDAP Ablatherm Integrated Imaging High Intensity Ultrasound PMA submission.
It is important to recognize that this Panel was tasked with making recommendations to the FDA regarding the safety, efficacy and the risk/benefits ratio of the EDAP Ablatherm Integrated Imaging High Intensity Ultrasound device. It was not a review of HIFU technology in general.
EDAP was not able to present adequate data to support the endpoints defined in their submission. The original trial was proposed as a non-randomized comparison of HIFU to cryotherapy in the target population with a two-year follow up period. EDAP was unable to enroll patients in the cryotherapy arm and failed to enroll the required number of patients in the HIFU arm. Instead, EDAP presented multiple data sets, which were determined by the Panel to be non-equivalent. As a result, their submission was considered to be insufficient by the Panel to make a favorable determination.
It is important to note that the Panel did not comment negatively on HIFU as a technology. In fact several members of the panel were both complimentary and encouraging regarding the development of HIFU. Peter Lewin, an advisory panel member and biomedical engineering professor at Drexel University said “I’m somewhat troubled by the statistical data. My reading of the tea leaves was that it was inconclusive and inadequate. A wonderful technology that is coming out is getting a bad rap because of badly designed statistics.”
The FDA has recently approved the EDAP Ablatherm device and the SonaCare Medical Sonablate device for prostate tissue ablation in the United States.
Several studies have been published on HIFU effectiveness with both the Sonablate device and the Ablatherm device. Please see the TREATMENT section for a discussion of these results. It is the opinion of the Scionti Prostate Center that is well selected patients, HIFU is a clinically effective treatment option for men with localized prostate cancer that better preserves urinary and sexual function.
HIFU Treatment can be directed at the entire prostate or to only a region of the prostate if a focal targeted treatment is planned. Simply put, HIFU treatment can be delivered to as much or as little of the prostate as required as determined by advanced diagnostic techniques discussed in Advanced Diagnosis.
The urethra consists of different anatomical segments. From the tip of the penis to the base of the bladder: the fossa navicularis (or meatal opening), the pendulous urethra, the membranous urethra and the prostatic urethra. During total gland HIFU, the entire prostate is destroyed, including the prostatic urethra, as it can have cancerous cells in it. In doing so, the end result is an empty cavity that acts like a conduit during normal urination. However, the urethra is derived from a different type of tissue (derived from the bladder squamous type epithelium) vs. prostatic tissue (glandular, fibrotic and muscular) and regenerates or re-epithelializes with time. The external sphincter and bladder neck are the vital structures with respect to maintenance of urinary function, NOT the urethra. These vital structures are not affected or harmed during HIFU. In the case of a focal HIFU treatment, the urethra is PRESERVED.
HIFU treatment is not covered by most insurance plans. There is no Medicare or TRICARE coverage for this treatment. Some private PPO insurance plans have reimbursed patients for the treatment after the fact. However, there is no guarantee of reimbursement. Men who elect HIFU pay for their treatment out of pocket.
Dr Stephen Scionti , through Vituro Health, offers HIFU treatment to patients at the Vituro Health Sarasota HIFU Center at 600 N Cattlemen Road, #100, Sarasota, FL.