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Is Hifu Fda Approved For Prostate Cancer

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Focal Therapy Versus Removing The Prostate

HIFU is FDA Approved, but Should You Get It? We ask Prostate Expert, Mark Scholz, MD

Depending on how much the cancer has grown, the doctor can choose to remove all of the prostate or just the tumor alone. Focal ultrasound treatment has even less risks for side effects.

To take out only a tumor, the doctor will use MRI during the treatment. The doctor only treats the tumor, while staying away from important areas like the nerves for erection and for controlling the bladder.

What Is The Prostate And How Common Is Prostate Cancer

The prostate is a reproductive gland in men. It is located in front of the rectum in the lower part of the intestine. It is about the size of a walnut and produces fluid that makes up semen.

Prostate cancer is very common in men in the United States. One in five men will be diagnosed with prostate cancer.

List Of The Pros Of The Hifu Treatment For Prostate Cancer

1. HIFU is approved by the FDA for treatment of prostate cancer.Although the high-intensity focused ultrasound procedure was hanging in limbo for several years waiting for regulatory approval, it is now available to men in the United States when they receive a diagnosis of prostate cancer. There are two systems currently available that can treat tumors or destroy diseased tissue, making it a useful option for many men. Medicare has already agreed to cover the treatment with their coverage protocol as well, which should impact its level of availability in the near future.

2. It doesnt take long to produce the results that you want.The HIFU treatment option takes four hours or less to successfully deal with the prostate cancer. Some patients can have their procedure completed in 60 minutes because of how effective it is. Before you can have it done, your doctor will want you to have an enema to ensure that your bowels are empty. There is also a restriction in place that you cannot eat or drink anything for at least six hours before having the operation.

Some men report that they have trouble urinating after having the HIFU procedure. They might also leak urine between trips to the toilet. There can also be pain between your rectum and testicles that medication can treat. Rare side effects include a UTI, blood in the urine, and a testicular infection.

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How Long Is The Hifu Procedure

The procedure typically takes 2 to 4 hours depending on the size of your prostate. After your brief recovery from your outpatient HIFU procedure you can be discharged home the same day. Thats a remarkable contrast to the hospitalization required for radical prostate surgery or radiation treatment that can take up to 7 weeks to complete.

How Does Hifu Work

HIFU for Prostate Cancer Treatment Approved for Use in the ...

If you’ve ever used a magnifying glass to reflect the sun’s rays and start a tiny fire or burn a hole into a leaf, you already have an idea of how HIFU works. Instead of light rays, though, HIFU uses sound waves that a doctor points through the wall of your rectum — the bottom part of your large intestine. They’ll direct the waves at your cancer cells.

The sound waves heat up to temperatures as high as 90 C and can kill cancer cells in just a few seconds. Doctors use magnetic resonance imaging and ultrasound imaging to find out exactly where the tumor is and where to point the sound waves.

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Hifu Prostate Cancer Treatment Without Hospitalization

Another great advantage of the HIFU treatment is, that the patient will not have to stay in hospital and will be able to go home the same day. Most patients will even be able to go back to the office the next day.

Altogether, this means that the total costs of having a focused ultrasound prostate cancer treatment could be less than traditional cancer surgery. Just think about all additional costs and also time away from the job.

You could say that there are many reasons why this treatment method became very popular very fast, with both patients and doctors.

One of the great things of using focused ultrasound is that it is very precise and does not come with the negative effects of traditional surgery procedures. The treatment is radiation-free and there will be no blood loss.

HIFU not suitable for spread out cancer

Unfortunately, focal ultrasound therapy is only useful if the prostate cancer has not yet spread out. Also, the doctor will look at the PSA score of the patient. A PSA of more than 20, would mean that the prostate is simply too big for a HIFU treatment. In that case, the doctor will advise to try a different form of treatment first, in order to see if that would help shrink the prostate.

Cary Robertson Md Is A Board


Cary Robertson, MD, Journal of Urology, April 2016, Volume 195, Issue 4, Supplement, Pages e198-e199

Urology Health magazine , Fall 2017, Did You Know?

Focal High Intensity Focused Ultrasound of Unilateral Localized Prostate cancer: A Prospective Multicentric Hemiablation Study of 111 Patients. Rischmann P. et al, European Urology 2017 February 71:267-273

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What Is The Recovery Process

During the first several weeks after the procedure patients typically experience urinary symptoms such as frequency and/or urgency to void. In the first one to two months patients may pass small amount days of blood, old prostate tissue or mucus-like material in the urinary stream. A urinary catheter is inserted and typically stays in your bladder for 2 weeks. Unlike catheters used after radical surgery, it does not go through the urethra so its far more comfortable and carries a much lower risk of infection. Dr. Pugach and his HIFU team will explain all of this to you in more detail when you come in for your consultation.

Potential Side Effects Of Hifu Affect Each Man Differently:

HIFU FDA Approval

Side effects include:

  • Erectile dysfunction Occurs in nearly all cases immediately after surgery. In extreme circumstances, ED can last 18 to 24 months or longer
  • Urinary incontinence Most men may experience some urine leakage for several weeks following surgery, but the condition typically resolves itself within a few months.
  • Ejaculatory dysfunction Occurs in all men
  • Retrograde ejaculation Develops in 40 to 90 percent of menOrgasmic issues Occurs in about 50% of cases
  • Penis shrinkage Frequent occurrence that can worsen over time
  • Nocturnal and morning erections Men typically lose these erections immediately following surgery, although they do return over time
  • Blood or tissue in urine It is typical to see some blood in your urine while the catheter is in place. You may also see some small pieces of prostate tissue in your urine for at least six to eight weeks following the procedure

Symptoms Include:

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First Us Study Shows Promising Outcomes For High

High-intensity focused ultrasound , a technology used to treat localized prostate cancer, has shown adequate control of prostate cancer while avoiding major side effects of surgery or radiation therapy, according to a new study in The Journal of Urology, Official Journal of the American Urological Association

With this non-invasive high-intensity focal ultrasound strategy, nearly 90 percent of men with localized prostate cancer were able to avoid or delay radical treatment , suggests the study by Andre Luis Abreu, M.D., of University of Southern California, Los Angeles, and colleagues. They write, Focal HIFU ablation is safe and provides excellent potency and continence preservation with adequate short-term cancer control.

Regulatory Approval And Reimbursement

Focused ultrasound devices have been cleared to treat the prostate in approximately 50 countries, including the United States. Several systems for focused ultrasound ablation of prostate tissue are available in various geographical regions, each differing in their guidance method and approach transrectal or transurethral.

While the Foundation attempts to keep the list of sites complete, there have been many purchases of the focused ultrasound systems. For the latest information on availability, we recommend contacting the manufacturers directly or using their online search functions.

There are three focused ultrasound manufacturers that are approved in the US for the ablation of prostate tissue Sonablate Corp., EDAP-TMS, and Profound Medical. Sonablate and EDAP deliver care outside of the MRI facility, so they are found in surgery centers and surgical suites, as well as in hospitals.

There are additional sites that use mobile focused ultrasound equipment. These sites may not be listed on the EDAP, Sonablate, or Profound Medical sites, and the best way to find them is to contact local urologists to see if they have focused ultrasound capability.

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Edap Announces Reimbursement Of Hifu Treatment For Prostate Cancer By France’s Ministry Of Health

Strong Recognition of EDAP’s HIFU Technology by France’s Health Authorities

LYON, France, April 21, 2014 — EDAP TMS SA , the global leader in therapeutic ultrasound, announced today the reimbursement of prostate cancer treatment procedures using High Intensity Focused Ultrasound by the French health authorities. The French Minister of Social Affairs and Health outlined the acceptance of HIFU treatment for prostate cancer for reimbursement during a visit to the Company’s headquarters on April 18, 2014. Such reimbursement is part of an innovative process to further validate breakthrough therapies and to accelerate reimbursement process based on clinical trials and data registries.

Pierre Reboul, EDAP’s VP of France’s Business Unit, commented, “We are very pleased with the French authorities’ decision to grant reimbursement as they recognize the benefits of HIFU technology as a treatment option for prostate cancer. HIFU treatment offers a non-invasive approach to treating prostate cancer that minimizes side effects such as incontinence and impotence, and therefore allows patients to preserve their quality of life. We are grateful for the support of the French Association of Urology for initializing the reimbursement process that led to today’s recognition and reimbursement.”


Forward-Looking Statements

Who Is A Candidate For Hifu

FDA approves device used to treat prostate cancer

Dr. Pugach advises that HIFU may be appropriate for men who have early stage, localized prostate cancer that has not spread or metastasized outside the prostate. HIFU may also be an effective therapy for recurrent prostate cancer when other treatment options have failed or pose a high risk of complications. A personalized consultation with a medical history and examination is required to determine if HIFU will work for you.

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Hifu Efficacy In The Treatment Of Prostate Cancer

Thousands of patient stories prove that prostate cancer is curable. Radiation therapy, radiosurgery and prostatectomy are the standards of treatment with survival rates exceeding 90%. However, after them, patients have a high risk of developing side effects in the intestines and genitourinary system. Treatment with high-intensity focused ultrasound can cure prostate cancer with less pronounced side effects.

HIFU for prostate cancer shows good long-term results. According to observations of French and German medical centres, the 10-year survival rate of patients after HIFU ranges from 92% to 99%.

The ultrasonic ablation procedure has side effects. The most common manifestations include incontinence, difficulties in urination, decreased erectile function. Studies by the French Association of Urologists have shown that these side effects gradually disappear in 97% of patients.

The FDA has approved HIFU for prostate cancer treatment.

Promising Results With Hifu In 100 Men With Localized Prostate Cancer

With several options available, men with localized prostate cancer can feel overwhelmed when making a decision about their treatment. While radical prostatectomy and radiation therapy can effectively treat the cancer, they have high rates of side effects, including impotence and incontinence . For very carefully selected patients with low-risk and non-aggressive prostate cancer, active surveillance may be utilized to monitor any growth of the disease.

For those seeking alternatives, HIFU is an option which enables the surgeon to precisely target the area of the prostate where the cancer is located. Using high-intensity focused ultrasound energy to rapidly heat and destroy the targeted area of the prostate, HIFU is a non-surgical and non-radiation, one-stop and outpatient treatment.

This approach, called partial gland ablation, aims to avoid or delay radical treatment and its inherent quality of life deterioration, Abreu and coauthors write. They reviewed their experience with HIFU in 100 men with localized prostate cancer.

Outcomes were assessed a median of 20 months after hemi-gland HIFU ablation of the prostate. The primary outcome of interest was treatment failure, including recurrent prostate cancer, the need for radical treatment, namely radiation therapy or surgery to remove the entire prostate, or occurrence of prostate cancer metastases or death.

For more information:

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Hifu Ultrasound Approved By Us Fda For Prostate Cancer Treatment

The US Food and Drug Administration have fully approved High Intensity Focused Ultrasound Therapy therapy after more than 10 years of clinical trials for the treatment of localized prostate cancer.

The procedure is also approved by Health Canada, and consists of one treatment for men with stage T-1 or T-2 organ-confined prostate cancer. The HIFU therapy is used on patients who failed treatment with radiation therapy, and can be repeated if necessary. Prostate cancer is the main cancer affecting men in North America, according to the American Cancer Society, affecting 200,000 men in 2015, with more than 25,000 fatalities. HIFU treatments are already approved in Europe and more than 40,000 patients have been treated around the world.

Maple Leaf HIFU has the most experience in treating prostate cancer patients with Ablatherm HIFU integrated imaging device in North America. The device has a computer-controlled rectal probe that is used to target the tumor and destroy the prostate tissue using ultrasound waves, without damaging surrounding organs. The treatment option has minimal side effects.

Dr. William Orovan, lead urological surgeon, said, 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.

Does Hifu Help Cure Primary And Secondary Liver Cancer

HIFU and Prostate Cancer: What You Need to Know

HIFU-therapy is recognized as an effective method for treating inoperable liver cancer. 44% of patients live for 5 years, if the cancer process was diagnosed at the 1st or 2nd stage, provided that the liver cancer was treated with chemotherapy or radiotherapy. The researchers at the Journal of Cancer found that 79% of patients successfully undergo HIFU sessions, after which the tumour begins to shrink. In 30% of cancer patients, the tumour is destroyed.

The disadvantage of HIFU is that 8% may have complications. These include obstruction of the biliary tract, pleural effusion, fistula formation, as well as burns, pain and fever.

Treatment with HIFU-therapy for liver cancer is possible in European clinics.

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What To Expect During Hifu

HIFU treatment is like using a magnifying glass to intensely heat an area with sunlight. Ultrasound waves are the energy source, and high heat burns the cancerous tissues.

HIFU procedures generally last two to three hours as outpatient procedures. During treatment, your physician:

  • Places a probe in your rectum
  • Focuses high-energy ultrasound waves on your prostate while monitoring the treatment area
  • As a targeted therapy, HIFU treats cancer only within your prostate, which minimizes side effects. Doctors can preserve the muscles, nerves and body structures responsible for nearby bodily functions.

    Fda Panel Rejects High Intensity Focused Ultrasound For Early Prostate Cancer

    There are many ways to kill prostate cancer cells. Radiation and chemotherapy are the most widely used. Freezing is another. A French company wanted to add heat generated by ultrasound waves to the armamentarium, but an FDA advisory panel has said no.

    The heat technique, known as high-intensity focused ultrasound , is being used in several countries for treating localized prostate cancer. To administer high-intensity focused ultrasound, a doctor inserts an ultrasound probe into the rectum, then focuses beams of sound waves on cancerous portions of the gland. Supporters say that high-intensity focused ultrasound offers a noninvasive way to target cancer cells that wont damage the nerves that control a mans ability to have an erection.

    As part of its standard review process for all new devices, the FDA convened a panel of experts whose job was to assess the available data on the safety and effectiveness of HIFU for localized prostate cancer.

    Unpublished results showed that high-intensity focused ultrasound was not highly effective. Nearly one in three prostates treated with HIFU tested positive for cancer in biopsies taken two years after treatment. It also posed a high risk of side effects, with more than half of the men treated with high-intensity focused ultrasound experiencing erectile dysfunction, urinary retention, incontinence, or other health problems.

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    Perhaps You Scheduled A Trip To The Bahamas Last Holiday Seasonto Get Hifu Prostate Cancer Surgery

    Thats right, before high intensity focused ultrasound was legal in the United States, Charlottes very well-known Dr. Samuel Peretsman traveled outside the country to help his Charlotte-based patients get this procedure done.

    He provided this procedure for nearly ten years by traveling to meet his patients from Bermuda to Mexico to the Bahamas. While he did so, the United States held off on legalizing this treatment, waiting to see its results in the more than forty other countries that had already approved HIFU for cancer treatment.

    However, in October 2015, HIFU was approved by the FDA for use. Dr. Peretsman, a urologist in Charlotte, was among the first to perform the surgery on a prostate cancer patient in early December in the United States.

    Lets learn more about HIFU and Dr. Peretsmans drive to make this treatment available to his patients.

    Hifu Prostate Cancer Treatment At Iu Health

    HIFU as Alternative Therapy for Prostate Cancer ...

    IU School of Medicine physicists and engineers with help from IU Health surgeons pioneered HIFU treatment for prostate cancer in the 1990s. Since then, we have made it even more effective. We remain leaders today in improving and administering this minimally invasive treatment.

    As one of the first training centers in the U.S., we teach doctors nationwide how to perform HIFU. We are also one of the highest-volume HIFU centers in the country. Our urologists bring this unparalleled expertise and experience to your treatment. We also offer:

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