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.
Making Hifu Available For More Patients
Dr. Ehdaie says that using MRgFUS for intermediate-risk cancers became possible due to two important developments over the past 15 years. First, there was an acceptance by experts of using active surveillance for low-grade tumors. The second advance was new imaging technology that enabled MRIs to be incorporated into ultrasound treatment.
In the phase 2 clinical trial, 101 men received the novel MRgFUS treatment and then were biopsied six months and 24 months later. There was no intermediate- or higher-risk cancer left in the treated area for 88% of the patients.
Probably most important was the lack of side effects, Dr. Ehdaie says. Nobody in the study reported urinary incontinence or experienced bowel problems. Most men were able to achieve erections.
Based on this data, the FDA in December 2021 granted approval for the technology, called Exablate Prostate, to treat prostate tissue. The FDA also approved an investigator-initiated trial designed by Dr. Ehdaie and surgeon Peter Scardino to compare MRgFUS focal therapy to active surveillance and demonstrate a clinical benefit for patients with prostate cancer.
Who Can Have Hifu
HIFU might be suitable for you if your cancer hasnt spread outside your prostate and has been classed as either CPG1 or CPG 2 / CPG 3 for how likely it is to spread to other parts of the body.
HIFU is sometimes an option if your prostate cancer has started to break out of your prostate, has spread to the area just outside the prostate or has a high risk of spreading. But your cancer may be more likely to come back after treatment than in men with localised cancer.
HIFU isn’t an option if your cancer has spread outside your prostate to other parts of your body .
HIFU can also be used to treat cancer that has come back after previous HIFU or radiotherapy . This is called salvage HIFU.
HIFU may not be suitable if you have a large prostate. Focal HIFU may still be an option if the areas of cancer are close enough to the probe for the ultrasound to treat. Your scan and biopsy results will show whether this is the case. Whole-prostate HIFU may still be an option if you have another treatment, such as a transurethral resection of the prostate , laser treatment or hormone therapy, to shrink the prostate first.
In the UK, HIFU is only available in specialist centres in the UK or as part of a clinical trial. This is because it is newer than some other treatments, so we dont know how well it works in the long term.
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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.
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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How Does Hifu Help Treat Prostate Cancer
This minimally invasive prostate cancer treatment uses sound waves to target cancer cells through the wall of the rectum. Using MRI and ultrasound imaging, Dr. Kasraeian will determine where exactly to direct the sound waves before beginning the treatment. The sound waves will heat to around 90 C during the treatment, effectively destroying cancer cells while avoiding harming the surrounding skin.
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
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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.
Can Prostate Cancer Be Managed
Typically, there are 3 ways to manage prostate cancer. Because prostate cancer is slow-growing, it may not have a significant impact the wellbeing of most men for the remainder of their lifetime. For these conditions, active surveillance may be recommended, giving the patient and the doctor more time to assess the progression of the disease and consider options for treatment.
When more significant treatment is recommended, it may include surgery or radiotherapy, or both. These treatments tend to be a final procedure, where the treatment plan is designed to eliminate the progression and spread of cancer cells without the need for additional treatment. Recent innovations, such as with robotic surgery for prostate, reduces recovery time while retaining function, but can still produce some side-effects. Other advancements exist in radiotherapy devices, which has vastly improved treatment delivery methods and clinical outcomes.
HIFU treatment provides an additional treatment option that is designed to bridge the gap between active surveillance and the more significant treatments, such as radical prostatectomy . HIFU Focal One® treatment consists an ultrasonic probe that scans the entire prostate structure then focuses sound waves at only the cancerous portion of the prostate from within the rectum.
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What Does Hifu For Prostate Cancer Treatment Look Like
Before starting the HIFU treatment, it is important to ensure that the bowels are empty. Therefore an enema is given before the procedure, and eating and drinking must be avoided for at least 6 hours. General/ spinal anesthesia is used for maximum comfort.
- You will be asked to lie on the right-hand side of the urologist as he inserts a finger-sized gel-coated ultrasound probe into your rectum and positions it to your prostate level.
- An imaging transducer in the center of the probe scans your prostate and creates a three-dimensional computerized image of your entire prostate and the area to be treated.
- After a thorough analysis, the urologist creates a precise plan of action, which is implemented through focused ultrasound beams on the targeted tissue.
- One beam lasts for around 20 seconds and kills about a rice grain size of the tissue at a time. Therefore a series of beams are targeted until all the diseased tissue is destroyed.
- The procedure takes around 2-3 hours but depends upon the tissue size that needs treatment.
- The HIFU machine has many safety checks, which are continuously monitored throughout the procedure to ensure your safety.
Future Perspectives Of Hifu For Cancer Treatment
HIFU is a non-invasive method of destroying a target tissue without skin incision whilst sparing adjacent tissues and organs, using real-time imaging guidance and control. The HIFU treatment involves relatively little pain and can be carried out with conscious sedation and on an outpatient basis. Such a technology provides a personalized treatment, adjusted to the individual patient anatomy, pathology and treatment response. The combination of Magnetic Resonance Imaging and Focused Ultrasound , known as MRgFUS, provides an ability to plan and monitor treatment in near real time, with MRgFUS further increasing the safety profile of FUS due to real-time temperature mapping . Combined strategies have been recently addressed, in order to match the advantages of both imaging modalities . Moreover, MRgFUS allows for achieving a higher degree of accuracy in ablation of the affected tissue . In particular, MRI has the unique ability to monitor temperature and cavitation level in real time .
Opposite to thermal induction, the mechanical impact from HIFU might be considered as an alternative for eliciting apoptosis. In a recent study, researchers exploited MR-guided HIFU for inducing apoptosis, where moderate acoustic power was applied .
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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 doesnÃ¢t 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.
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
- 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
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The Principle Rationale Of Tissue Preservation Is Harm Reduction And Functional Preservation
Adverse events affecting the urinary tract are reported in 2-58% of whole gland HIFU therapy in the literature. Rectal toxicities ranged from 0 to 15%. Erectile dysfunction is reported in 0 to 39% of cases . Toxicity rates are believed to be lower after focal therapy. In our case series, 31 consecutive patients with unilateral organ confined prostate cancer were primarily treated by hemiablation HIFU. Early self-resolving LUTS were the most common complications and no rectal toxicities were reported. The strategy was well tolerated in the genitourinary functional domains: all patients were pad free continent despite a high number of apical lesions and only 25% of men in our cohort of relatively elderly patients who were potent preoperatively reported having ED post hemiablation. The procedure could possibly be delivered in an ambulatory care setting .
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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:
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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What Is The Recovery Time For Hifu
Each person is unique, and each use of HIFU for medical treatment is different. In general, HIFU has a quicker recovery time than other, more invasive forms of treatment.
Your healthcare team will tell you what to expect and how long itll take you to recover after your HIFU procedure.
A note from Cleveland Clinic
High-intensity focused ultrasound has a wide range of applications for medical treatments. Its minimally invasive and usually has a short recovery time. If you have any questions about HIFU or the procedure process, dont be afraid to ask your healthcare provider. Theyre available to help.
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:
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What Is Hifu Treatment
High intensity focused ultrasound is sometimes used as a treatment for early prostate cancer or prostate cancer that has come back after radiotherapy. It is given as part of a clinical trial, so it is only available in some hospitals in the UK.
HIFU treatment is given under a general or spinal anaesthetic. A probe is gently passed into the back passage . The probe makes a high-energy beam of ultrasound. This heats the affected area of the prostate and destroys the cancer cells. The probe is surrounded by a cooling balloon. This means the high-energy beams are only given to the areas with cancer in them and normal prostate tissue is protected.
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