HIFU Treatment
Learn if HIFU is right for you.
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. The Focal One device was approved in 2018. 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 over 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. However, most American urologists have little experience with this treatment.HIFU is currently discussed as a treatment option within the current American Urological Association guidelines for the treatment of localized prostate cancer.
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.
Significant technological improvements have been made in HIFU technology over the past several years. These improvements include rectal wall cooling, improved imaging, MRI fusion-guided treatment planning and tumor targeting. The current and most advanced HIFU technology allows a highly experienced surgeon to confirm prostate tissue destruction in real-time as the procedure is being performed. MRI images can be fused or merged with ultrasound images in the HIFU planning and treatment delivery 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 combination of over a decade of HIFU experience and over 1000 patients and allows for MRI Mapping of the tumor over the ultrasound images and energy Modulation to assure more effective tumor ablation with less side effects. Dr. Scionti also refers to this technique as “MRI targeted dose escalation”.
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 Scionti Prostate Center located at Lakewood Ranch Medical Center. With over 2,000 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 noninvasive treatment to kill prostate tissue with focused sound waves. Currently, men with organ-confined prostate cancer can elect to have either total gland or targeted focal HIFU treatment performed by Dr. Scionti through the Scionti Prostate Center. The Scionti MMM (Triple M) HIFU technique is only available through Dr. Scionti in Sarasota.
NOTE: The CPT code, 55880, provides Medicare reimbursement for the outpatient hospital fees associated with HIFU treatment. Traditional Medicare insurance has paid for the hospital fees in all of our Medicare patients over the past several years. Although most commercial insurance plans, as well as some Medicare Advantage plans, do not provide coverage for HIFU treatment, many of our patients have been able to recover a portion of the costs by filing an appeal with their insurance carrier.
Is HIFU Effective?
One of the most important and comprehensive studies on the effectiveness of HIFU is demonstrated by the HIFI study, which was published in December 2024 in European Urology. This landmark study is the first of its kind and the largest prospective comparative multi -center clinical study ever conducted evaluating the oncologic and functional outcomes of different localized prostate cancer treatments with over 3,000 patients. This independently run trial provides meaningful clinical evidence supporting the use of the Focal One robotic HIFU device for the treatment of localized prostate cancer. It also offers a comparison to radical prostatectomy.
In summary: 3,328 prospective patients were enrolled, including 1,967consecutive HIFU patients and 1,361 Radical Prostatectomy patients across 46 centers.
The study met its primary endpoint of HIFU providing non-inferior salvage treatment free survival at 30 months (90% for HIFU vs 86% for Radical Prostatectomy) while delivering superior functional outcomes in terms of continence and erectile function preservation.
Here is the key takeaway message from this study: This nationwide trial was the first to prospectively compare high intensity focusedultrasound (HIFU) and surgery for the treatment of localized prostate cancer. The results demonstrate that medium-term salvage treatment outcomes are comparable with a better safety profile favoring HIFU. In other words, the percentage of patients who required secondary or additional treatment for their prostate cancer was similar in the groups of patients who had HIFU compared to surgery.
Dr. Scionti offers MRI-guided targeted HIFU utilizing the Focal One robotic platform through the Scionti Prostate Center. Dr. Scionti has taken a leading role in studying the outcomes of HIFU and compiling results from HIFU procedures performed outside of the United States prior to FDA approval, as well as participating as the lead Proctor and the FDA HIFU salvage trial at NYU. These efforts contributed greatly to the clinical data set, which led to approval by the FDA in 2015 of the Sonablate HIFU device for the ablation of prostate cancer.
The HIFU Treatment
HIFU is a non invasive treatment and recovery is usually fast with full return to normal activities within a week. FDA Approved for Prostate Ablation
Before HIFU:
Preparation for HIFU begins with 36 hours prior to treatment. My patients begin a clear liquid diet on the morning prior to their treatment. The administration of 2 FLEETS enemas two hours prior to the procedure ensures that the rectal cavity is clean and free of any debris that can block passage of the sound waves into the prostate gland.
During HIFU:
Precision HIFU treatment requires that the patient be absolutely still. Therefore, a general anesthetic is administered during the procedure. A cooling catheter will be inserted into the urethra. Over the years, Dr. Scionti has advanced the technique of urethral cooling during the procedure to provide protection to the urethra. The urethral cooling technique minimizes catheter time and protects the urethra from damage and scar tissue formation. A HIFU treatment probe or transducer is inserted into the rectal canal. This transducer device sends ultrasound waves directly through the rectal wall and into the prostate tissue. MRI images are used to assist in the design of the treatment. During the procedure, the HIFU device delivers real-time images of your prostate and the surrounding area, giving immediate and detailed feedback information.
Treatment time varies, but generally the procedure lasts 1-1/2 to 2 hours, depending on the size of the prostate and the extent of the prostate that needs to be treated. Careful monitoring of the treatment screen allows the experienced HIFU surgeon to monitor the effectiveness of each HIFU pulse, ensuring that the targeted tissue is successfully treated.
MRI image guidance or MRI fusion permits precise tumor localization and allows for enhanced delivery of energy to the tumor. This proprietary technique is also called the Scionti MMM technique (MRI Mapped energy Modulated) or what we now refer to at our center as MRI Targeted Dose Escalation (MTDE)
After HIFU:
Immediately after HIFU procedure most patients typically spend one to two hours recovering at the treatment facility and then are discharged. At that time I will prescribe some basic medications, but most patients do not experience any pain after the procedure. You will be discharged with the catheter in place as it will be necessary to ensure that the bladder empties properly in the early post HIFU recovery. This catheter will remain in place anywhere from a 3 - 10 days. The catheter time is based on the extent of your HIFU treatment and the size of your prostate. In cases of targeted focal treatment, the catheter is only needed for a few days.
Post HIFU care:
You will be in close contact with my HIFU care team during the initial recovery phase. If you live a significant distance from Sarasota, you will be speaking with my HIFU Care team every few days until your catheter is out and you are voiding well. If you are local to Sarasota, you will be followed very closely in my office. You will have your first PSA blood test at 3 months post-procedure. This 3-month PSA test represents your new baseline or nadir (low point) level and I will ask you to get your PSA every 3 months in year 1 post HIFU and every 6 months thereafter. If you live at a significant distance from Sarasota, it would be ideal to see me personally for a visit at the time of your 1-year anniversary post HIFU.
Local patients in Florida are encouraged to visit our center annually for follow-up.
This facilitates the ability to get a state-of-the-art MRI done and at one ofthe highly experienced imaging centers that we utilize. However, virtual or TeleHealth follow-upvisits are available.
Current standards of medical practice require you to visit our office either inperson or virtually annually to allow for proper monitoring of your progress and provide ongoing prostate cancer care.
Potential Side Effects and Complications
All treatments for prostate cancer carry some risk for potential side effects and complications.
Common side effects can include frequent urination, urgency to urinate, and mild discomfort with urination. A urinary tract infection can occur in the first few weeks after a HIFU treatment.
Numerous clinical studies document that severe side effects such as urinary incontinence are uncommon. It is rare for our patients to experience urinary incontinence that requires diapers or a protective pad. Most patients can expect to preserve excellent erectile function.
Focal or partial gland treatments carry a lower risk of side effects if you are a candidate for a focal HIFU procedure.
As with any medical procedure, all potential side effects and complications should be directly discussed with Dr. Scionti prior to undergoing treatment. As with all treatments for prostate cancer, cancer recurrence is possible and is related to the severity and to the extent of your prostate cancer.
The Pros and Cons of HIFU
These are the Pros or advantages of HIFU treatment for prostate cancer:
- Noninvasive, radiation-free treatment.
- Allows precise, MRI Fusion guided ultrasound energy delivery to the prostate
- Outpatient treatment
- No incisions and rapid recovery
- If cancer returns, surgery, radiation, or additional HIFU treatment is possible.
- Focal or partial treatment of the prostate is possible guided by MRI mapping and energy modulation (Scionti MMM, triple M HIFU)
- Very Low Risk for urinary leakage problems
- Excellent preservation of erectile and sexual function
- Traditional Medicare insurance will cover facility and anesthesia costs, greatly reducing out-of-pocket costs for our traditional Medicare patients. For patients who have Medicare Advantage plans or commercial insurance plans, coverage is variable, and our team will work with you and your insurance company to determine whether or not insurance coverage is available for your treatment.
These are the Cons or disadvantages of HIFU treatment for prostate cancer:
- Many US urologists are still unfamiliar with HIFU even though it was approved in theUnited States in October 2015 for prostate tissue ablation.
- Research studies and results are only published out to 15 years of follow-up, so longer term outcomes , beyond 15 years are unclear.
- Not every man is a candidate for HIFU and factors such as prostate size, extent of cancerand presence of stones or calcifications in the prostate can affect success rates.
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Successful HIFU treatment requires significant physician training and experience. Relatively few U.S. urologists have acquired significant experience with this treatment.
- Some patients may require a prostate reduction procedure, such as a transurethral vaporization or resection, prior to HIFU treatment. You will discuss this in detail with Dr. Scionti if your prostate is not of the appropriate size for a successful procedure.
- Successful results from a HIFU treatment require a highly experienced and skilled HIFU surgeon. Since there are still relatively few HIFU specialty centers in the USA, many patients will have to travel to a center of excellence in order to have a safe and highly effective treatment.
- Since HIFU is not covered by all insurance plans, many patients may have significant out-of-pocket medical expenses. You will discuss this in detail with the care team at the Scionti Prostate Center.
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.
- Age
- 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)
Questions to Ask Your HIFU Doctor
Several factors determine appropriateness of HIFU. Men who are excellent candidates are very likely to have an excellent results. 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.
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.
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.
Post HIFU care and counseling are 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 resulting 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.
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.
Frequently Asked Questions
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, HIFU or TULSA-Pro. Please take the time to learn about all of the options.
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.
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.
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.
HIFU Disclaimer
IMPORTANT INFORMATION: HIFU is FDA Approved for Prostate Ablation
The Sonablate and Ablatherm devices were cleared by the FDA in 2015 for prostate tissue ablation, but not specifically for prostate cancer. The FDA approve the HIFU devices as tools whose specific use was left open to the judgment and experience of a patient's physician.
HIFU treatment is available at our HIFU Treatment Center in Sarasota, Florida. The information provided on this website is for general information purposes only and is not intended to replace sound professional medical advice and care. All treatment options and potential outcomes and complications should be discussed with a qualified physician.
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