Potential Side Effects Of Hifu Affect Each Man Differently:
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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Questions To Ask Your Doctor Or Nurse
- What are the advantages and disadvantages of HIFU?
- Where is this treatment available?
- Can I see the results of HIFU treatments you have carried out?
- What are my other treatment options?
- Will I have focal HIFU or whole-prostate HIFU?
- What are the side effects of HIFU? How likely am I to get them?
- How can I manage any side effects I get?
- How will I know if the treatment has worked?
- How likely is it that Ill need more treatment after HIFU?
- What treatments are available after HIFU?
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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Who Can Be Treated With High
High-intensity focused ultrasound is approved by the Food and Drug Administration for the ablation of prostate tissue. Who the best candidates are for HIFU is somewhat debated by urologists.
HIFU can be considered:
- As an alternative option to monitoring for patients who have early stage prostate cancer.
- As an alternative to or follow up to radiation or surgery or other failed treatment for tumors that are small and confined to an area of the prostate.
What Are The Cons Of Hifu Therapy
Its not right for everyone
HIFU is typically used only for localized prostate cancer . Its best suited for men who are in the early stages of prostate cancer. In more advanced stages when the cancer has moved beyond the prostate, HIFU therapy isnt effective.
Its relatively new
As a treatment for prostate cancer, HIFU has been in use for a little less than two decades outside of the United States.
In the U.S., the Food and Drug Administration approved HIFU for prostate-related treatment in October 2015. Dr. Klein says its important to note that this method is FDA approved for ablating prostate tissue. It is not FDA approved for treating prostate cancer, specifically. Thats an important distinction, he says.
Its not widely available
Because of the fairly recent FDA approval, not all hospitals offer the treatment. Dr. Klein says there are only a few sites in the United States that have the most modern devices for delivering HIFU.
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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.
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:
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.
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External Review By Ontario Clinicians
The PEBC external review process is two-pronged and includes a targeted peer review that is intended to obtain direct feedback on the draft report from a small number of specified content experts, and a professional consultation that is intended to facilitate dissemination of the final guidance report to Ontario practitioners.
Following the approval of the report by the PEBC Report Approval Panel, the GU DSG circulated the practice guideline and systematic review to external review participants for review and feedback.
During the guideline development process, 6 clinical or methodological experts from Ontario, Quebec and British Columbia were identified by the GU DSG. These experts were contacted by email and asked to serve as reviewers. Three reviewers agreed to participate in the review, and the draft report and a questionnaire were sent to them via email. The questionnaire consisted of items evaluating the methods, results and interpretive summary used to inform the draft recommendations and whether the draft recommendations should be approved as a guideline. Written comments were invited. The GU DSG reviewed the results of the questionnaire.
Edap Announces Reimbursement Of Hifu Treatment For Prostate Cancer By Frances Ministry Of Health
Strong Recognition of EDAPs HIFU Technology by Frances 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 Companys 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, EDAPs VP of Frances 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 todays recognition and reimbursement.
About EDAP TMS SA
Forward-Looking Statements
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Nyu Langone Medical Center First In Northeast To Utilize New Technology Allowing Surgeons To Destroy Only Suspicious Prostate Tissue
For the estimated 220,000 men who will be diagnosed with prostate cancer this year, deciding on a method of treatment can be a challenge. Some with early-stage cancer pursue a wait and watch option, also called active surveillance, while others with more severe cancer immediately pursue surgery, including prostatectomy . Others fall somewhere in the middle. For those men, an exciting new, minimally invasive therapy might be an optimal treatment approach.
High intensity focused ultrasound , or focal therapy, is a new concept for treating prostate cancer pioneered by clinician-scientists at NYU Langone Medical Center. The goal is simple: Destroy only the clinically significant cancer within the prostate while sparing adjacent structures and minimizing side effects, such as erectile dysfunction and urinary incontinence.
This technology provides important treatment for a niche group of men with prostate cancer who otherwise have limited options for care, says Herbert Lepor, MD, the Martin Spatz Chair and Professor of Urology at NYU Langone. It was rewarding to see our first patient leave our outpatient facility in the afternoon, enjoy dinner with his wife that night, and report no adverse impact on erectile function three days later.
What Happens Afterwards
You will have check-ups with your doctor or nurse at the hospital at first, and then with your GP. This is often called follow-up. The aim is to:
- check how your cancer has responded to treatment
- deal with any side effects of treatment
- give you a chance to raise any concerns or ask any questions.
You will have a PSA test every three to six months for the first few years to check how well the HIFU has worked. Your PSA level is likely to reach its lowest level a few months after HIFU. You may also have a prostate biopsy or MRI scan after treatment to check your prostate cancer has been treated successfully.
If you have focal HIFU, you might have low-risk cancer in another area of the prostate that is not treated on purpose. You will have regular tests to monitor the cancer that isn’t treated. These might include PSA tests, MRI scans, and prostate biopsies.
After HIFU, your PSA level should fall and then stay low. A continuous rise in your PSA level can be a sign that the cancer has come back. If this happens, your doctor may suggest you have further tests, such as an MRI scan and a biopsy. Sometimes they might also suggest other types of scan, such as a CT scan, MRI scan or bone scan, to see if the cancer has spread to other parts of your body. If you need other scans, your doctor or nurse will tell you more about these.
If your cancer does come back after HIFU, you may be able to have further treatments that aim to get rid of it or control it. You may be offered:
- more HIFU
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How Hifu Is Performed
On the day of your procedure, the healthcare staff will get you comfortable. The procedure typically uses the following steps:
- A thin tube is passed through your penis into your bladder to drain the urine
- The probe for HIFU is inserted into your rectum
- The high-intensity ultrasound is used to destroy the cancer cells
- The doctor looks at a screen to ensure that it is properly placed
- The probe may be moved around to target more than one area
- The probe and catheter are removed
Depending on the area being targeted, it takes one to three hours to perform most HIFU procedures. After a short while in recovery, you can usually go home.
When you are diagnosed with prostate cancer, your doctor may present more than one treatment option to you. Learning more about HIFU ensures that you have a general understanding so that you can work with your doctor to determine if it is a viable treatment option.
At UCI Urology, our prostate cancer specialists are compassionate and experienced in selecting the best treatment or combination of treatments for each situation.
UCI Urology – Orange
High Intensity Focused Ultrasound : A Prostate Cancer Treatment
There is a new treatment option for patients with prostate cancer that is confined to the organ, and not spread to other areas of the body. High Intensity Focused Ultrasound is a minimally invasive, out-patient, and radiation-free procedure that patients can undergo in a few hours and return home the same day. This advancement in the treatment of prostate cancer is making it possible for patients with earlier stages of the disease to maintain their quality of life without surgery. Even if the prostate cancer returns, no matter what form of treatment was previously used, High Intensity Focused Ultrasound can be used again for localized treatment. The use of HIFU also does not rule out other treatment options for recurring cancer.
Sonablate HIFU Procedure
There are several forms of High Intensity Focused Ultrasound : . Standard HIFU Procedure: Ablation of the entire prostate gland. . Focal HIFU Therapy: Targeted only to the area in the prostate gland where the tumor is located. . Salvage Treatment: Option for patients with a recurrence of prostate cancer.
During the procedure, Tissue Change Monitoring Software allows surgeons to monitor the prostate tissues reaction to the ultrasound waves in real time and make any alterations when needed. The precision of the Sonablate HIFU allows for flexibility in the procedure, making it possible for physicians to offer a customized treatment plan tailored to each patients diagnosis.
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What Are The Advantages Of High
Advantages of high-intensity focused ultrasound include:
- It requires no surgical incisions into the body and doesnât use radiation.
- It can exactly target diseased tissue, leaving non-targeted healthy tissue unharmed.
- It is an outpatient procedure with a short recovery time. You can usually return to work or normal life in about 24 hours.
- It reduces the risk of urinary incontinence and erectile dysfunction compared with surgery or radiation therapy.
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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Results Of The Multicentric European Study
Interim results from a European multicentric prospective single-arm treatment are available. Six investigational sites participated and 652 patients with clinically localized prostate cancer were recruited. The treatment consisted of a full prostate HIFU application. Follow-up included prostate biopsies at 3, 6, and 12 months and then every year or based on PSA relapse. PSA was evaluated every 3 months. The study started in 1995, and patient inclusions were completed in October 2000. Results with the first 402 patients with a median follow-up of 407 days are available. The treatment efficacy was evaluated according to the stringent response criteria: response was quoted as complete if PSA was lower than 1âng/ml and biopsies were negative partial if PSA was more than 1âng/ml or increasing with a negative biopsy and failure if biopsies were positive. Interim results were based on post-treatment biopsy only. Taken all together, biopsy response rates were 87.2% however, response rates varied according to pretreatment characteristics. Stratification in low risk , intermediate , and high risk showed biopsy responses of 92.1, 86.4, and 82.1%, respectively. An extended follow-up will be needed to correlate post-treatment biopsy response to the long-term response of the disease .
Figure 5
Focal One High Intensity Focused Ultrasound For Treating Prostate Cancer
- Posted in Urology
In February 2019 Saint Johns Cancer Institute at the Providence Saint Johns Health Center became the first medical center in the U.S. to acquire Focal One high intensity focused ultrasound for treating patients with localized prostate cancer. Focal One is one of the most precise tools available for delivering targeted, non-invasive ablation of diseased prostate tissue.
Saint Johns Cancer Institute at Providence Saint Johns has received worldwide acclaim for advances in cancer treatment and research, including research in prostate and liver cancer. The institutes unique ability to rapidly turn scientific breakthroughs into innovative approaches to treatment and early detection provides immediate hope to cancer patients from around the world.
Mehran Movassaghi, M.D., MBA, is the Director of Pacific Mens Health at Providence Saint Johns, and Assistant Professor of Urology at the Saint Johns Cancer Institute, which offers the most comprehensive medical services for men in the Los Angeles area. Dr. Movassaghi and his team specialize in urologic conditions that men face, including prostate cancer. We asked Dr. Movassaghi to discuss the significance of HIFU for prostate cancer treatment and the technological breakthroughs of Focal One.
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