Dr. Scionti answers frequently asked questions about HIFU
- What prostate cancer treatment options do I have?
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.
- What is the history of Sonablate HIFU and how long has it been done?
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.
- Is Sonablate HIFU FDA approved?
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.
- Why did the FDA INITIALLY reject the EDAP Ablatherm HIFU Trial?
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.
- Has HIFU been well studied? Is it effective?
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.
- Does HIFU only target the cancerous cells or does it ablate the entire prostate?
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.
- If the entire prostate is ablated, does that include the urethra? What happens to the urethra? Is it damaged?
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.
- Is HIFU covered by insurance?
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.
- Where does Dr Scionti offer HIFU treatment?
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.