Although a relatively new procedure in the U.S. HIFU technology has been successfully performed on more than 15,000 men in over 30 countries for more than 15 years. HIFU is a minimally invasive, outpatient procedure that uses focused ultrasound energy to target and destroy prostatic tissue. HIFU was approved by FDA in the U.S. for prostate tissue ablation in October 2015 and since that time more than 5,000 men have undergone the procedure.
Over 10 years ago, and prior to its approval by the FDA, Dr. Bilowus travelled to several countries to train, and to perform this breakthrough surgery.
Ken Morris, who has early-stage prostate cancer, chose to undergo a new procedure at a private clinic in Toronto. (CBC)
Some men with prostate cancer are paying for a new treatment to target cancer cells called high intensity focused ultrasound, which is less invasive than surgery or radiation.
HIFU, which was developed in the United States about 15 years ago, is a computer-controlled probe that is inserted into the rectum and emits ultrasound beams inside the prostate where it creates enough heat to destroy targeted tissue.
A few months ago, Ken Morris was diagnosed with early-stage prostate cancer and elected to undergo the procedure at a private clinic in downtown Toronto that offers the less-invasive treatment.
"That was one of the first qualities of HIFU that attracted me to it," he said. "No cutting, no stitching."
Morris was a candidate for the procedure because his cancer was not aggressive. He was sold on the promise of fewer side effects commonly associated with prostate surgery despite the hefty fee.
"The likelihood of erectile dysfunction seems to be somewhat lower," said Dr. Laurence Klotz, a urologist at Sunnybrook Health Sciences Centre in Toronto. "We can do a nerve-sparing HIFU treatment, which really doesn't treat the nerves at all, and the rate of incontinence or difficulty controlling the urine also seems to be significantly lower than with surgery."
About 15,000 men around the world have undergone the treatment.
Dr. Joseph Chin, a urologist at London Health Sciences Centre in London, Ont., is doing a clinical trial using HIFU and looking at whether it is safe, effective and extends the lives of men for whom radiation therapy hasn't worked.
After recently undergoing the procedure, Morris said HIFU was the best choice for him.
"I'm very pleased that I'm feeling so good, sitting at my house, talking to you normally right now," he told CBC News. "That's one thing I didn't expect. I expected to feel a lot worse."
"A pioneering treatment for the UK's most common male cancer is more successful than surgery or radiotherapy," The Daily Telegraph reported. The newspaper said that new research shows that intensive ultrasound therapy is as effective as traditional treatments (surgery or radiotherapy) but that side effects are dramatically reduced.
This research found reasonably favourable results from high-intensity focused ultrasound (HIFU) treatment in men with localised prostate cancer (cancer that had not spread). It also found that there were relatively low rates of urinary incontinence and erectile dysfunction following treatment.
At present, treatment for localised prostate cancer is normally either radical (surgery or radiotherapy) or involves ‘watchful waiting’, where the cancer is monitored but not treated unless it develops. As such, minimally invasive alternatives like HIFU may be a preferable alternative. However, as with other newer alternative treatments for prostate cancer, available evidence is from small case series only and information on long-term outcomes is lacking. Further follow-up of men treated with HIFU and randomised controlled trials to directly compare the new treatment with surgery are needed.
Where did the story come from?The research was carried out by Dr HU Ahmed and colleagues from University College London. Funding was provided by the Prostate Research Campaign UK and Prostate Cancer Research Centre UK. One of the authors received funding from and is a consultant for Negma Lerads, a manufacturer of a photodynamic agent used in prostate cancer therapy. The study was published in the peer-reviewed British Journal of Cancer.
What kind of scientific study was this?This research examined the effectiveness of high-intensity focused ultrasound (HIFU) at treating men with localised prostate cancer. Men with localised prostate cancer normally have the options of radical treatment, such as surgery or radiotherapy, or monitoring, a process known as active surveillance or watchful waiting. However, the decision between doing nothing or having radical treatment is not an easy one.
HIFU is known as a minimally invasive therapy and, along with other alternatives such as radiofrequency ablation, cryosurgery and photodynamic therapy, offers a middle-ground approach. It has a potentially reduced risk of adverse effects compared to radical treatment and is more proactive than watchful waiting. However, these therapies are in various stages of research and development and their use in clinical practice is limited.
HIFU involves focussing high-energy ultrasound waves on the target cancerous tissues, which causes them to coagulate and die. The probe that emits the ultrasound waves is inserted into the rectum and a cooling balloon around the probe protects the surrounding healthy tissue. After the procedure, catheterisation is required for a period of time.
This case series reported on men (average age 64 years) who received HIFU at two London centres between February 2005 and May 2007. The men had rejected surveillance and were either unable or did not wish to undergo surgery or radiotherapy. The men understood that HIFU was not a standard procedure and that knowledge of short- and medium-term outcomes was restricted to a few case series. Men were excluded if they had any specific symptoms that made HIFU inadvisable (contraindications), including a prostate volume greater than 40ml, calcification of the prostate or significant anorectal disease preventing probe insertion (for example, previous haemorrhoid removal or inflammatory bowel disease).
Some of the men who were included were pre-treated for three months with low-dose anti-androgen (anti-male hormone) treatment to reduce the size of their prostate. In procedures carried out earlier in the case series, standard urethral catheters were inserted for one to two weeks following HIFU. In later procedures, this was replaced with a suprapubic catheter.
Follow-up of the men was the same as that used for standard radical treatment. Serum PSA (prostate specific antigen, a prostate cancer marker that indicates disease activity) measurements were taken at six weeks and then every three months for the first year and every six months during subsequent years of follow-up. At one of the centres, patients also completed questionnaires that assessed any adverse effects they had experienced.
What were the results of the study?Of the 172 men treated with HIFU, analysis was only possible in 136 cases as there was not complete data for risk stratification in the other 36 men. Of the 136 men analysed, 27.8% (38 men) were considered to have low-risk disease, 37.5% (51) had intermediate-risk disease and 34.6% (47) had high-risk disease. Following treatment, 78% of the men were discharged after an average of five hours. Average duration of follow-up was 346 days (range 135–759 days).
Adverse effects of HIFU were given as:
Men who received post-treatment suprapubic catheterisation were significantly less likely to experience urethral stricture (narrowing of the urethra causing difficulty in passing urine) than men who received urethral catheterisation (19.4% against 40.4%). Antibiotics for suspected urinary tract infection were given to 23.8% of men. Epididymitis (infection and inflammation of a structure at the back of the testicle where sperm is stored) developed in 7.6% of men. Mild urinary incontinence occurred in 7% (12 out of 172) and one man needed to use pads for more severe incontinence. After one year, the majority of men (70%) were still able to achieve erection. There was no report of rectal problems following the procedure. Overall, 78.3% of the men achieved a low PSA level one year after treatment (0.5 micrograms/ml or lower, and below 0.2 micrograms/ml in 57.8% of men) and 92.4% of men (159 out of 172) either achieved a low PSA level or had negative biopsy results, demonstrating no residual disease. Of the 13 men who were candidates for further treatment, eight received further HIFU, one had salvage radiotherapy and four were managed with active surveillance for low-risk disease.
What interpretations did the researchers draw from these results?The authors concluded that, in the short term, good outcomes can be achieved following HIFU, with reasonably low levels of erectile dysfunction and urinary incontinence. However, longer-term outcomes need to be assessed.
What does the NHS Knowledge Service make of this study?This case series has found reasonably favourable outcomes following HIFU treatment in 172 men with localised prostate cancer. This minimally invasive technique is an alternative for men who would otherwise only have the options of radical treatment (and its associated risks and adverse effects) or watchful waiting. However, as with most new techniques, it should be remembered that the evidence is limited to small case series only.
At present, the main limitation of this particular procedure is that there is little information available on longer-term outcomes. As the authors say, an international registry of all cases treated with HIFU would be helpful to document its success. However, it will be some time before this could become a standard treatment option and the outcomes of much larger numbers of men who have had this treatment are needed. The best-quality evidence would come from randomised controlled trials that compared HIFU to standard options (surgery, radiotherapy or watchful waiting) and other minimally invasive options. Headlines like “Prostate cancer treatment more successful than surgery” are not accurate at present.
Current NICE guidance advises that the evidence supports the safety and efficacy of HIFU for prostate cancer, provided that monitoring, audit and clinical governance of any procedures are carried out. It advises that longer-term effects on survival and quality of life are unknown, and that doctors should therefore ensure that patients understand these uncertainties and the alternative treatment options.
LYON, France (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that the Association of Italian Urologists (AURO) has recommended High Intensity Focused Ultrasound (HIFU) as a standard of care for the treatment of prostate cancer as part of the Association's new guidelines on prostate cancer diagnosis and therapy.
The recommendation and updated guidelines on the use of HIFU for prostate cancer are based on the significant number of HIFU patients treated in Europe to date and on a comprehensive review of the current literature highlighting the positive clinical outcomes and acceptable follow-up.
AURO is recommending HIFU as a standard of care treatment for localized prostate cancer, highlighting its major advantage as a minimally invasive approach and because side effects following a HIFU procedure have proven to be very low, preserving patient quality of life. AURO recommends the use of HIFU for primary care patients with localized prostate cancer (T1-T2 stages) and for those who are not suitable for, failed or rejected radiotherapy or surgery. Italian urologists also consider the use of HIFU for locally advanced tumors (T3 stage), based on preliminary positive results. Finally, HIFU is also used in case of local relapse of cancer after radical prostatectomy or radiotherapy as no other alternative is being offered to these patients and also as a palliative treatment for other forms of the disease.
Sergio Pontecorvi, Managing Director of EDAP Italy, commented, "I am extremely pleased with these updated recommendations as they will clearly help in positioning our minimally invasive HIFU option with urologists eager to offer the best treatment options to their patients with prostate cancer. These guidelines confirm the growing adoption of HIFU as a valid alternative to existing therapies while preserving patient quality of life. The low side effects associated with a HIFU procedure are significant benefits to highlight when a patient is considering a treatment option for his cancer."
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "The AURO recommendations are fully in line with the French Association of Urology's recent publication which further validates HIFU's position as a new standard of care for the treatment of localized prostate cancer. The clear and concrete support from 2 major scientific and clinical communities in Europe is a major step forward in favor of our program to focus on driving deeper adoption of our HIFU technology among the urology community. Ablatherm-HIFU continues to build momentum in Europe and we also remain dedicated to our focus on increasing awareness of HIFU's benefits to patient quality of life."
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA, the ENLIGHT US clinical Study. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the company, please visit http://www.edap-tms.com, http://www.hifu-planet.com and http://www.pcaresearch.com.
In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
USHIFU, LLC, the exclusive distributor of the minimally invasive HIFU for prostate cancer treatment in North and South America, announced that the June 16, 2008 edition of ABC News NIGHTLINE featured a segment on high intensity focused ultrasound (HIFU) for treating prostate cancer outside of the United States using HIFU.
According to the segment, men diagnosed with prostate cancer have the ability to travel outside of the United States to receive HIFU, a non invasive, outpatient procedure for prostate cancer.
The segment failed to mention that the HIFU treatment is currently involved in two different FDA-approved clinical trials in the United States to gather data important for analysis of the technology by the FDA. The first is a pivotal trial for the treatment of primary organ confined prostate cancer that will enroll 466 participants at 24 different centers. A second pivotal trial will begin for the treatment of recurrent prostate cancer in men who have failed external beam radiation therapy.
Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine and medical monitor for the trials said, "I have personally reviewed the preliminary data and observed HIFU in action and I am impressed with this advanced technology for ablating the prostate. These rigorous clinical trials will add to the international data already available and will further help define the appropriate role of HIFU device in the treatment of prostate cancer," Lepor added.
If patients meet the enrollment criteria they may qualify to enroll in the U.S. HIFU clinical trials.
"HIFU offers non invasive treatment option for men who are looking for a therapy that will not completely disrupt their lives. A story on a prominent news program, such as ABC, NIGHTLINE increases awareness of the procedure and encourages people to conduct personal research to see if HIFU is a treatment option they should consider," said Steve Puckett, Jr., USHIFU Chief Executive Officer.
In the program, NIGHTLINE followed HIFU patient Richard Brightmire, as he traveled to Cancun, Mexico to have HIFU in February. According to the story, Brightmire chose HIFU because he wanted to preserve his quality of life and he was not satisfied with the other treatment options that were presented to him.
Four months after his procedure, Brightmire's PSA is zero and he has maintained his quality of life. "I'm doing fine since the HIFU procedure. Everything is back to normal," Brightmire said.
"I think that NIGHTLINE stressed sexual preservation as the main reason for going with HIFU. It's my belief that sexual preservation is only one of several important aspects," Brightmire continued. "For me, I went with the procedure because of the results outside the U.S. that show it to be non-invasive and show a lower risk of long-term hospitalization, and a lower risk of incontinence as well as impotence especially compared to surgery and other treatments available today."
USHIFU recognizes that, as the segment mentions, not all physicians are advocates of new prostate cancer therapies, "We understand that there is a very high bar of scrutiny for new prostate cancer treatment modalities, as there should be," Puckett said. "We highly encourage physicians to evaluate the technology for themselves and explore the international clinical outcomes that exist."
"In the program I found it particularly interesting that Dr. Patrick Walsh, of John Hopkins University was referenced as an expert with regards to HIFU. To my knowledge he has never seen or used our technology. We extend an invitation for him, as well as any other physician, to come see HIFU firsthand and learn," Puckett added.
HIFU was developed by Focus Surgery, Inc. and is manufactured by Misonix, Inc. (Nasdaq: MSON) who also holds distribution rights in Europe. Takai Hospital Supply Ltd. and THS International distribute HIFU system in Southeast Asia and the Middle East.
This is a new option for men with unifocal or unilateral Prostate Cancer. (This means a single tumour inside the prostate or several tumours but all on the same side of the prostate gland). With FOCAL HIFU only the tumour is treated and not the whole gland. It uses a high energy focused ultrasound beam, which is directed across the wall of the back passage into the prostate to heat and destroy a very precise volume of tissue. The aim of FOCAL HIFU is to leave untreated as much of the healthy tissue as possible. It is the equivalent treatment for men with prostate cancer which is available for women with breast cancer - the male lumpectomy.
FOCAL HIFU could be suitable for men with low or intermediate risk Prostate Cancer, who have unifocal or unilateral disease. If following the careful prostate mapping, your clinician is sure that the cancer is confined to a specific area in the prostate, they then can just treat these areas with HIFU and monitor the untreated areas.
The good news is that this will allow you to avoid or reduce the damage to surrounded structures such as the muscle controlling urine flow and the nerves controlling erections whilst still offering cancer control. This means you can have a treatment for your prostate cancer without all of the associated side-effects with other treatments.
The benefits of Focal HIFU:
- By treating the tumour not the whole gland there are fewer side effects
- Preservation in most cases of the vital structures around the gland therefore preserving long term continence, erectile and orgasmic function
- Shorter procedure (20 minutes to one hour and a half hours) and almost always no hospital stay required
- Rapid return to normal life after treatment
- Almost 100% of patients maintain sexual potency
- No incision is required which avoids the risk of surgical infection
- The procedure can be repeated as necessary
All men are followed up after FOCAL HIFU with PSA tests every three months. If the PSA rises then further diagnosis is undertaken, but for approximately 90% of men treated, FOCAL HIFU should be the only treatment required. If further treatment is required this is usually a further HIFU treatment, though any of the traditional treatments including surgery and radiotherapy are possible after FOCAL HIFU.