Non-Invasive HIFU Treatment for Prostate Cancer Receives Full FDA Approval

HIFU or High Intensity Focused Ultrasound Therapy, the non-surgical treatment that has been used to treat men with prostate cancer, has finally received full approval from the U.S. Food and Drug Administration.  Ablatherm HIFU is on track to become the treatment of choice for localized prostate cancer in American men, as it is in other countries.

The FDA has fully approved Ablatherm HIFU

The FDA has fully approved Ablatherm HIFU

After more than 10 years of clinical trials, EDAP TMS SA, the manufacturer of Ablatherm HIFU Integrated Imaging devices, received 510(k) clearance from the FDA for U.S. usage.  Over 40,000 patients worldwide have had HIFU treatments for the ablation of prostate tissue to treat cancer. HIFU first received approval in Europe and has also been approved by Health Canada.

Prostate cancer is the number 1 cancer affecting North American men.  According to the American Cancer Society, about 200,000 men will be diagnosed with prostate cancer this year, from which over 25,000 will die.  Early detection and treatment are key.  HIFU is intended to treat men with organ confined prostate cancer in the earlier stages (T-1 or T-2).  HIFU is a single treatment but it can be repeated if required.  Patients who have failed radiation therapy are also candidates for HIFU.

The Ablatherm Integrated Imaging device precisely delivers ultrasound  through a computer controlled rectal probe.  This is an outpatient procedure that is an alternative to traditional prostate cancer treatments like radiation and surgery, but with minimal side effects. HIFU is a proven treatment method that is effective and efficient, with early success determination.  Of course, it is important to choose a facility with a great reputation and doctors that are certified and experienced in using HIFU technology.

Maple Leaf HIFU, located in Toronto, was the first provider of  Ablatherm HIFU in North America and has performed more HIFU procedures than any other clinic in North America.  Procedures for patients from the U.S. and Canada are conducted at the world class Cleveland Clinic Canada. This downtown clinic is staffed by top urologists who specialize in prostate cancer.  Their doctors are all experienced and certified in the HIFU method and have also conducted multiple clinical studies proving the benefits of using HIFU as a prostate cancer treatment method.

Dr. William Orovan, the lead Urological Surgeon,  clarifies: “Ablatherm HIFU has the best patient safety outcomes by far and cure rates are excellent. Side effects of HIFU, including incontinence and erectile dysfunction, are much less than traditional surgery or radiation.”

To determine if you might be a candidate, or for more information and published clinical studies involving FDA Approved HIFU to treat prostate cancer, visit:

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Prostate Cancer Radiation Therapy or Prostate Removal – Hernia Risk

Prostate removal or radiation therapy for cancer treatment is linked to a two- to
four-fold higher than usual risk of later having a hernia repaired, according to
a new Nilsson, Hanna MD; Stranne, Johan MD, PhD; Stattin, Pär MD, PhD; Nordin, Pär MD, PhD.

Groin hernia repair after having prostate cancer surgery or radiation therapy was assessed and the conclusions remain that there was an increased HR – hazard ration of groin hernia repair according to age and tumor risk category.

It is unclear if damage to surrounding tissue during surgery or treatment may have something to do with the outcome. It seems that those patients that underwent a radical prostatectomy had an even higher incidence than those that underwent radiation therapy.

“One study of 1,700 men published last year found that some men can avoid hernia
surgery – without any untoward health effects- by watchful waiting (see Reuters
Health story of March 22, 2012).”

Read the full article:

SOURCE: Annals of Surgery, online June 6, 2013.

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Prostate Cancer Treatment Options 2013

Prostate cancer treatments are making strides as development of individual treatment methods continues to eveolve.  When the cancer is caught in the early stages and remains localized, it is much easier to treat with a successful outcome using a variety of techniques.

Tradional treatment includes prostate cancer include surgery, radiation therapy or seeds, brachytherapy, hormone therapy and even watchful waiting. Long term outcome data are now available for several types of treatment to confirm the effectiveness of the various treatment types.

This article takes into account that prostate cancer may be multifocal in nature so the detection of small foci of disease could result in a better “targeted therapy.” – read more

The university study goes on to say:” HIFU seems to result in short- to medium-term cancer control, as shown by a high percentage of negative biopsies and decreased PSA levels”.

It is important to consider various opinions before making an informed decision regarding treatment depending on the individual’s circumstances.


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HIFU Pros and Cons

HIFU research 2012 indicates postive results.HIFU as a viable treatment option for prostate cancer, is coming of age and seems to be joining the ranks of accepted treatment options.  There are two main machines that adminster the HIFU treatment under the care of a qualified urologist; Ablatherm HIFU and Sonablate HIFU.

HIFU is still undergoing clinical trials in the United States awaiting FDA approval, but has been an acceptable treatment worldwide for over a decade.  In North America, the first clinic to pioneer the treatment here is the Maple Leaf HIFU clinic in Canada.  Americans fly to Toronto to receive the Ablatherm HIFU treatment.  The latest HIFU research has been published in 2012 with positive results.  There are other treatment locations in Mexico and the Caribbean.

There are advantages over other types of treatment such as surgery or radiation, which include less cases of impotence or other long lasting side effects. Qualifying for HIFU treatment depends on the stage of the cancer, age and general health.  Quality of life issues are considered when selecting the appropriate prostate cancer treatment.

In some cases, active surveillance or not doing anything with respect to a treatment, is selected while the growth of the cancer is monitored until the cancer is more evident.

Pros and cons relate to the amount of research that had been available prior to 2012. With a small sample size, statistics were sometimes conflicting and the treatment was still considered one that is under further investigation in the U.S. despite worldwide acceptance.  With a decade of followup and the recent 2012 research, this minimally invasive treatment is gaining acceptance in the mainstream medical community. The final word will be the FDA approval that may be forthcoming as early as 2013.

Advantages to HIFU treatment include the minimally invasive treatment modality which does not involve a scalpel or external application of radiation to the body.

The statistical discrepancies are narrowing as more and more research is conducted, but it seems not more than a fifth of patients treated with HIFU had to undergo additional treatments.  See the published results for accurate medical statements.

Some cons or negatives to the HIFU treatment include possible incontinence, scarring of the prostate which can lead to difficulty urinating, ED – although the rate is very low, and the risk of further treatments becoming necessary down the road.  Another negative about HIFU is that, since it is not yet approved by the FDA in the states, the treatment is costly for some, since most insurance will not cover it.  But finances aside, the treatment itself is safe and effective, non-invasive and carries with it minimal side effects for the treatment of organ-confined prostate cancer.

Finally, a Gleason Score of 8-10 requires a different treatment method as HIFU is usually only used for Gleason Scores up to 6 (3+3) for organi confined cases.

The imaging tools allow objective location of the disease through scanning.  This is much more precise than random biopsy.   One major advantage of HIFU is that after the treatment, the patient can carry on with normal day to day living without a long recovery period.  Treatment one day and golf, fishing or boating the next, is very appealing to many and a reason why HIFU will continue to gain in popularity after FDA approval.

UCLA medical center is the only center conducting trials of the HIFU procedure on the West Coast of the U.S.  With a risk of metatisis, HIFU uses the same ultrasound waves that are used on pregnant women, but they are focused so they generate the high heat that can kill the cancerous tissue.  Nothing goes through the skin, it is a very precise, computer controlled operation that lasts about 2 hours.  Patients typically go home the same day with almost no pain or side effects.  PSA levels are monitored.

Once the decision is made to employ a particular treatment, then selecting the right facility to have the treatment done is paramount.  With HIFU, the selection is either to use the Sonablate or Ablatherm machine.  Ablatherm HIFU has treated more patients in North America (in Toronto) than Sonablate and the experienced team there has offered the treatment since 2003.

When considering other treatments from active surveillance, brachytherapy, cryotherapy or surgery, HIFU is rising in visibility and effectiveness as a viable and successful treatment for organ-confined, early stage prostate cancer.





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Prostate Cancer

Prostate Cancer

The importance of early detection of prostate cancer cannot be overstated. The risks of it developing unnoticed are far too great. The Canadian Cancer Society estimates that prostate cancer will be found in 26,000 men each year. It is the most commonly found cancer in Canadian men and there is a 1 in 7 chance that it will happen to you. There is a 1 in 28 chance that you will die from it.  Statistics in the U.S. show 250,000 men will be diagnosed with prostate cancer this year. So, you see, it cannot be just ignored.


The prostate is about the size of a walnut in some men. In others it may be as large as a small apple. It produces seminal fluid which carries semen during orgasm.

It sits atop the urethra and has 2 small lobes which wrap around the urethra. It is the muscle tissue in these lobes that allow you to control the flow of urine. It is located under the bladder, in front of the rectum.

Early Signs and Detection

Because prostate cancer has few symptoms in its early stages, its very important that you pay attention and watch out for these signs.

  • An intense need to urinate
  • Frequent urination throughout the night
  • Trouble starting or stopping the flow of urine
  • Unable to urinate at all
  • Weak urine flow
  • Feeling as though your bladder is still full even after urinating
  • Pain or burning while urinating or during orgasm
  • Blood in your semen or urine

While these are prostate cancer symptoms, they do not necessarily mean you have prostate cancer. There could be other underlying health reasons that cause the same symptoms, so it is best to visit your doctor.

If you’re a man over 50 or think you have any of the prostate cancer symptoms, talk to your doctor. Tests can be done to determine whether you have prostate cancer. The first test is generally a digital rectal exam, where the doctor will insert a gloved finger into the rectum to feel if the prostate seems enlarged or hard.  If you are in a high risk category, or the doctor wants to check further, then you will probably be given a PSA or prostate-specific antigen test. This test gives a reading of protein which made by the prostate and compared to a chart for normal levels in your age range. A low PSA level of less than 4 ng/mL, would  generally indicate that no further testing is required. When PSA Levels are high or rising, your physician will want to evaluate further.

If prostate cancer is suspected, a biopsy will likely be performed. A biopsy is the only positive way to diagnose prostate cancer. Biopsy tissue samples are compared to normal prostate  tissue samples. They are then given a Gleason score of one to five, with one being normal and five being highly abnormal. Your doctor will look at the PSA scores to determine the stage of the cancer and how aggressive it is.

To confirm the presence of prostate cancer, a biopsy is usually conducted, by which a tiny portion your prostate is removed and examined for cancerous growths. If the disease is detected, the next step is to find out how far it has spread.  Your urologist will examine a tumor’s size, giving it a grade from 2 up to 10, based on a Gleason score rating system.

Your risk category will be determined by the number and size of prostate tumors, combined with your PSA levels and Gleason score. This will help determine which treatments are options for you.

Treatment options will vary depending on the risk category and how far the cancer has progressed. Your age, health, race, lifestyle and family health history will be taken into consideration to determin the best course of action.

Risk Factors

Certain men may be more susceptible to the disease than others. Men of African or Afro-Caribbean descent have an increased risk of developing it. The chance of getting prostate cancer increases with age, with 80% of men over 80 contracting the disease.

Lifestyle too can play a part. In general, eating right and leading an active lifestyle can help reduce the risk of developing prostate cancer.

It is important to stress the importance of early detection. The Prostate Cancer Canada Network estimates that 90% of prostate cancer cases are curable if the disease is detected and treated during its earliest stages.

Eat right, stay active and get regular screenings if you are over 50, or younger if your blood relatives (father, son, brother) have a history of prostate cancer.

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Treating Prostate Cancer

What You Should Know About Treating Prostate Cancer

Treating Prostate Cancer

Knowing the various treatments for prostate cancer available and what the risks associated with each are is the first step in being informed about what will be one of the most important decisions of your life. The potential side effects of some of the treatments are too life altering to leave this decision to chance.

Have a discussion with your doctor. Ask questions about any side effects you need to be aware of. While your treatment options become less viable if your cancer has progressed beyond your prostate gland, it is important to be aware of what to expect after the treatment has been completed.

Here are some of the options open to you.


Surgical options available are as follows.

A complete prostatectomy where your entire prostate gland is removed     A lymph node dissection where only the nodes surrounding the urethra are removed     A transurethral resection is done in which small pieces of your prostate are removed

Each of the above procedures requires a hospital stay and you would be anesthetized and put under. They are effective in most cases although cancers have been known to return weeks or months afterward. As well, side effects can include urinary incontinence, impotence and infertility.


There are 2 common approaches to radiation therapy in treating prostate cancer, external beam radiotherapy and brachytherapy.

External beam radiotherapy is a procedure where a high energy radioactive source is used to project a beam at your prostate from a short distance outside your pelvic area. There is no anesthesia required and it is done on an out-patient basis. It is typically done on 5 consecutive days over a period of about 5 to 7 weeks.

Brachytherapy is the usage of about 100 to 150 small radioactive pellets or seeds. They are placed directly into your prostate with a syringe a few at a time; it usually takes up to 40 injections to implant them all. This procedure is painful and requires a general anesthetic.

These two procedures use radioactivity to burn away cancerous cells. Side effects include impotence, inflammation of the bladder and rectum and cancers have been known to return.


Drugs known to be toxic to cancerous cells are introduced to your body. It is used to slow cancerous growths and relieve pain. It is not a cure but it can be used to help patients where cures through other means are not possible.

High Intensity Focused Ultrasound (HIFU)

HIFU is a procedure that uses sound waves to destroy cancerous cells. A focused ultrasound beam is aimed only at the regions of the prostate that are diseased with cancer. The cells targeted are destroyed using heat. Surrounding tissue is not affected by the beam and remains undamaged.

The entire prostate can be exposed to the ultrasound beam in about three hours. The procedure is done quickly and is effective in eradicating prostate cancer in over 90% of patients treated. Side effects are minimal resulting in urinary incontinence in only 5% of patients. Only 8% suffered urethral blockage and about 40% suffered sexual impotence. Impotence drops to 20% in patients whose cancer does not affect the prostate nerve.

These reasons alone make HIFU the choice you should make when thinking about prostate cancer treatment options.

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