Rischmann Study On Hifu Treatment For Prostate Cancer
In the July 2017 edition of the Journal of European Urology, Rischmann, et al published a multi Center study from France including 111 men with localized prostate cancer. These men had prostate cancer on either the right or left side, and were deemed candidates for hemi- ablation. High Intensity Focused Ultrasound was used to treat the entire side with cancer, sparing the side without cancer. After 1 year, all the men underwent repeat prostate biopsy. 96% had no clinically significant cancer in the treated side, and 95% had no CSC in the untreated side. At 12 months, continence was preserved in 97% and erectile function was preserved in 78% of the men.
Ablatherm Hifu For Pc Primary Therapy
The authors identified 11 case series assessing Ablatherm HIFU as a primary therapy option in prostate cancer , which were conducted by four study groups in Germany, France, and the Republic of Korea . Between 58 and 402 patients with localized prostate cancer with a mean age of 6672 years were treated with HIFU. In 4 of 11 case series, patients were recruited consecutively . The mean preoperative PSA level was 712 ng/mL, Gleason score was 7 in most patients, and the mean preoperative prostate volume was 2137 mL. Between 0% and 43% of men received neoadjuvant ADT, and 65100% of patients underwent TURP before or in combination with HIFU. Patients received between one and three HIFU treatments most patients, i.e. 5796%, underwent one treatment. The mean follow-up period varied between 6 and 77 months. The biochemical disease-free survival rate was 66% and 77% after 5 years , and 69% after 7 years . The negative biopsy rate was assessed in all but one study and varied between 65% and 94% the time of biopsy was not specified. In one case series the negative biopsy rate was 86% at 3 months .
What Happens During The Hifu Operation
An ultrasound probe the size of your index finger is introduced into your rectum during high-intensity focused ultrasound while you are unconscious under anesthetic. The probe is positioned up to your prostates level. The prostate is found directly behind the rectum wall.
The probes imaging transducer scans your prostate to build a three-dimensional digital map of the entire prostate and the area to be treated. The computer is then used by your urologist to view and plan your precise treatment strategy. The treatment strategy is then carried out, with targeted ultrasound waves destroying the tissue that has been identified. At a moment, each focused beam of radiation destroys tissue the size of a rice grain. The procedure is repeated until all unhealthy tissue has been eradicated. Following the therapy session, imaging evaluates the treatments outcome.
Depending on the size of the treatment region, the procedure takes an average of two hours to complete.
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How Is The Recovery After Hifu Procedure For Prostate Cancer Treatment
Immediately after HIFU procedure for the treatment of prostate cancer there is a one to two hour recovery period at the hospitals and then you are discharged. Recovery is minimal. A suprapubic tube is inserted during the procedure that is usually worn for two to five weeks. People usually are up and walking around within hours after HIFU and can return to a normal lifestyle within a couple of days. Some HIFU patients experience frequency, urgency, mild discomfort or discharge in urinary stream. During your recovery time at home, a staff member is always available to guide you with any questions.
High Intensity Focused Ultrasound For Prostate Cancer
Dr. Mehran Movassaghi explains the benefit of HIFU Focal One treatment for prostate cancer.
High Intensity Focused Ultrasound provides clinicians more treatment options for prostate cancer using concentrated ultrasound to destroy tumor cells, while improving localization of the disease and preserving healthy surrounding tissues.
Using Focal One®, a medical device designed specifically for the treatment of prostate cancer, treatment combines HIFU technology and imaging fusion software. The treating urologist can view detailed 3D images of the prostate then draw a precise contour around the affected tissue, targeting only that portion of the prostate. This promotes improved post-treatment results with reduced side effects by avoiding the healthy areas of the prostate. With Focal One®, the urologist can customize the procedure for each patient and for each clinical condition.
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Commercially Available Hifu Devices And Treatment Technologies
As of 2011, two transrectal HIFU devices were commercially available for the treatment of PC, the Ablatherm and the Sonablate 500 . Although neither of the devices has received Food and Drugs Administration approval for marketing in the US, regulatory clearance is likely for the Ablatherm device when the results of a prospective trial become available .
Commercially available transrectal HIFU devices: Ablatherm and Sonablate 500 .
Nevertheless, the foundation science and technology of both systems is identical, but there are several technological differences between the two devices. These differences, for the most part, arise from different schools of thought with regards to how best to design the optimal HIFU treatment system. Specifically, the differences arise in how the manufacturers went about choosing operating frequencies and intensities. This is an optimization based on the effects that modifying these parameters will have influence on image quality and ablation ability .
The Ablatherm machine consists of a treatment module that includes the patients bed, probe positioning system, ultrasound power generator, cooling system for preservation of the rectal wall, and ultrasound scanner used during the treatment localization phase. There is also a treatment and imaging endorectal probe that incorporates both a biplanar imaging probe working at 7.5 MHz and a treatment transducer focused at a maximum of 45 mm working at 3 MHz .
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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The Sonablate Hifu Procedure
The HIFU procedure typically lasts between 1-4 hours, depending on the size of the prostate, and is done under general anesthesia. During the procedure a suprapubic or foley catheter will be put into place to help with urination, and will typically stay in place for 1-2 weeks. After the HIFU treatment, patients will be in recovery for about 1-2 hours. Once released from the treatment center, patients return home to recover more comfortably. Though, it is recommended that patients take things easy, most patients feel well enough to go out for dinner and maybe even a walk, the day of the procedure.
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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.
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Ablatherm Hifu For Pc Salvage Therapy
Ablatherm HIFU as a salvage therapy option in recurrent prostate cancer after EBRT failure was assessed in three case series , all of which were published from one study center in France . Between 71 and 82 patients were treated with HIFU following recurrence of prostate cancer after EBRT . In one case series patients were recruited consecutively . The mean patient age was 6771 years mean preoperative PSA level was 8 ng/mL, Gleason score was 8 in most patients, and preoperative prostate volume was between 21 and 35 mL. Neoadjuvant ADT was administered to between 9% and 30% of men. Patients were treated with HIFU, one to five times and were followed up for a mean of 1518 months. The negative biopsy rate was 80% at 15 months in one trial and between 78% and 80% in the remaining studies the time of biopsy was not shown .
What Happens During The Hifu Procedure
HIFU is created when electricity passes through a curved piezoelectric crystal producing a characteristic vibration. The vibration of the crystal results in waves of energy which, when focused on a prostate cancer cell, converts the energy to heat. Within 4 seconds, the temperature of the cell rises to 85 degrees Celsius, melting liposomal membranes, denaturing protein and disrupting cell walls. Additionally, negative pressure created by an internal bubble destroys the cell by a second mechanism. High Intensity Focused Ultrasound is extremely accurate and able to be directed with laser-like precision into cancerous tissues, while sparing delicate nearby structures including the nerves of erection, the urinary sphincter, and the rectal wall.
In HIFU treatment for prostate cancer, the ultrasound probe is placed gently into the rectum, next to the prostate. The high-intensity sound waves are focused with a laser-like precision to eliminate the cancerous tissue. The normal tissues of the rectal wall are safe, and preserved. Delicate nearby structures including the urinary sphincter, the nerves of erection, and the bladder, can be carefully avoided. For my patients, HIFU does not require a hospital stay, and they can resume most normal activities the next day. The possible side effects are notably less than other prostate cancer treatments including: surgery, radiation, and cryoablation. The long term results of HIFU are excellent, and highly effective.
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Medicare Elite Access Hifu Program
The Scionti Prostate Center welcomes Medicare patients who chose HIFU for prostate cancer treatment. CPT Code, 55880, enables Medicare reimbursement of hospital outpatient facility costs.
Elite Access Program Overview:
- HIFU procedure is performed at Lakewood Ranch Medical Center in Lakewood Ranch, The Florida Medicare carrier has paid the hospital charges in every single case over the past year. This program is the most successful Medicare HIFU program in the USA with well over hundreds of Medicare patients treated.
- Consultation with Dr. Scionti to develop a personalized treatment pathway for your prostate cancer that provides effective cancer treatment while maintaining your quality of life
- Personal access to Dr. Scionti and his HIFU care team as you undergo treatment.
- Our staff can assist you with Financing non-covered costs.
- Precision MRI Fusion Guided HIFU treatment personalized for your prostate cancer characteristics performed by the most experienced HIFU physician in the United States.
- Personalized Post HIFU care plan detailing follow-up, PSA testing, MRI monitoring, diet, lifestyle and nutritional supplement recommendations.
Albissini Study On Hifu Procedure For Prostate Cancer
Albissini, et al, in the January, 2017 issue of Journal of Endourology, published a study of 55 men who had undergone hemi-ablation for localized prostate cancer. The follow up was an average of 3 years, including PSA and repeat biopsy. Their results were matched to 55 men who had undergone Robotic Assisted Laparoscopic Prostatectomy . Failure of cancer cure was defined in terms of biochemical recurrence and repeat biopsy leading to salvage therapy with radiation or hormone deprivation. The results were statistically identical, with 6/55 in the RALP and 7/55 in the HIFU group. Both urinary continence and preservation of erectile function were superior in the HIFU group. The HIFU procedure group, despite being significantly older than the surgery group, had 82% zero pad use at 1 month vs. the surgery group, with 40% zero pad use. Preservation of erections was 80% for HIFU, and 15% for RALP at 1 month. At one year, zero pad use was 94.5% in the HIFU group, compared to 87% in the surgery group. Compared to HIFU, more than twice as many men were still incontinent one year after surgery for their prostate cancer. At one year, the return of erections was still 80% in the HIFU procedure group and just 38% in the surgery group . Not surprisingly, compared to HIFU, the rate of complications was significantly higher after Robotic Prostatectomy.
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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
How Does Hifu Work
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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Indications For Hifu Therapy Of Pc
The most widespread use of HIFU, and initially the only indication for its use, has been in patients with localized PC who are not candidates for surgery because of age, general health status, a prohibiting comorbidity or a preference not to undergo radical prostatectomy . However, with the accumulation of clinical experience and expansion of research protocols, these indications have broadened .
However, the indications have been expanded based on clinical experience to include partial and focal therapy in unilateral low volume, low-Gleason tumors, incidental prostate cancer after trans-urethral resection , salvage therapy in recurrent prostate cancer after radical prostatectomy, radiotherapy, or hormone ablation, for locally advanced prostate cancer as adjuvant local tumor-debulking therapy, non-metastatic as well as metastatic stages, and hormone-resistant prostate cancer . It is well accepted that the gland can also be downsized by 30% within 3 months of androgen deprivation therapy , besides TURP. Still remaining contraindications for the HIFU device are a missing or a small rectum and a damaged rectal wall, caused by previous prostatic/rectal therapies .
Access To Clinical Trials
Our prostate cancer specialists conduct clinical trials at the IU Health Academic Health Center. One trial involves using PSMA PET imaging in addition to MRI scans to plan HIFU treatments. PSMA PET imaging helps doctors more accurately target and destroy cancerous tissue while saving surrounding healthy tissue and nerves.
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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.