CBC take on HIFU....

Jean222 · Senior User Joined: 14 Dec 2008 Posts: 262

There was a segment on CBC news last night (Aug. 3) about
HIFU.

There is a study underway, in London Ontario, to see if HIFU is as good as professed/as good as regular treatment of PCa.

Seems there are excellent docs who think it's great and other excellent docs who are questioning the long-term outcomes of HIFU.

They're also questioning the out-of-pocket expense involved for all, as Canadians have to pay for this treatment.
It's not covered by provincial plans, yet.

You can read the article at: www dot cbc dot ca/health

The comments from readers/patients/etc are very interesting, to say in the least.

Enjoy!

Jean

notme · Guest

Bottom line--doctors are terrified at all the $$$$ they are going to lose.

Paying out of pocket was fine--it's worth $25,000. to be sure of living without side - effects!

The instance of side-effects is so low....it's hardly worth mentioning, but go with the most experienced doctor--they all charge the same!

Just think of how cheap HIFU will be when it's approved!!! Doctors won't have to travel out of country and take along their staff, stay in hotels, etc. etc.

Trouble with all these studies is they are done using inexperienced doctors...all this "no long term studies" is just a scare tactic. I found a lady whose husband had it done 8 years ago, he's sent others (6 or 7) and they all report cancer free, no side-effects. I've found a few who have to take Cialis or Viagra, but find that a small price to pay, published ED is 20-30%.

When you think of the workings of HIFU, it targets the prostate, cooks it and then you pee it out through the bladder catheter, surgery cuts the gland out, radiation targets the gland with radiation. No harmful effects from ultrasound (as long as your doctor knows how to use it ~ as it is High Intense Focused)

Am I happy I went HIFU? man, you have no idea. And I am thrilled that I can help other guys find this. The more of us that go to Mexico--the sooner they will approve it. Radiation didn't have to get FDA approvals.

Jean222 · Senior User Joined: 14 Dec 2008 Posts: 262

notme,

Long term consequences DO matter, both to the patient and to the government plans/insurance plans that will/will not pick up the tab for HIFU in the future.

I'm in Canada, our men don't have to travel out of country for it's approved here, as you know.

Our docs don't need to travel to do the procedure, they have clinics in which to perform the HIFU.

The docs in the HIFU clinics are some of the best prostate cancer oncologists in the country, as are the doc doing the research study.

These studies are very important, not scare tactics, IMO, as they may be the very studies required by the FDA to prove it to be a viable alternative to what you have in the US at the moment.

We, on this forum, know that you are very pleased with your outcome. This, you make very clear.
It is, however, not a long-term outcome for years to come....I do hope it works out for you over the coming years but even you have to admit that it's not perfect.

Nothing is perfect, in a perfect world, nobody would have cancer or any other nasty afflictions.

These studies, however, may prove/disprove HIFU as a viable alternative therapy.

Jean

notme · Guest

Of course studies are important, but the fact they use inexperienced doctors, who say after the study that "after they went through the learning curve the results were much better.." And they've been doing HIFU in Europe for 18 years, we just won't accept their data.

Using a doctor who has gone through the learning curve is so important, as he not only has learned the technique but he has learned what to tell the patient to do ~ drink 48oz of water a day to flush the ash out, only use soap and water, no neosporin....etc....I had pages of what to do, I've read some reports of guys having problems and I wonder if they followed all the rules.

The hospital in Puerto Vallarta is used by International HIFU 4 days a week, 5-6 years, I think that qualifies as being his clinic..

I wish we were as progressive as Canada! It should be approved!

Why do you think radiation was approved without any FDA studies.?

notme · Guest

Jean,
I have no doubt there are good HIFU docs in Canada, but I went to Mexico, so I can only report my experience. And, I've sent my friends to Mexico, so that's the limit of my personal findings. It seems to me the doctors in Canada should be charging a lot less than $20,000. being they don't have to travel with their entire office staff. They charge $12,000. in Europe and Japan, and $6,000. in Italy.

The lady I know whose husband had it done 8 years ago lives in the UK.

I said earlier: "....I had pages of what to do, I've read some reports of guys having problems and I wonder if they followed all the rules." I would like to add---maybe the guys who had problems weren't given the rules that experienced doctors now know to tell the patients. Quite a few were given foley catheters, which Scionti refused (I thought it sounded easier), as he said it is what causes urethral strictures (plugged up penis).

John M · Experienced user Joined: 27 Jul 2009 Posts: 59

The proposed clinical studies are a very good thing. Clinical trials of this device are also underway in the US. Looking up the medical literature on HIFU, I don't see that there have ever been any controlled long term studies to show that it is effective for treating prostate cancer, although there are a number of series reporting on the the short term effects of treatment.

If I were going to be treated with HIFU, I would not only want to know not only that it would have fewer bad effects than surgery or radiation, but that it actually worked. Before I went through the procedure, whether I was paying for it out of pocket or if insurance paid for it, I'd want to know that it would actually lower the chance that I would get sick and die from prostate cancer. If I had already decided that I wanted HIFU, no matter what, I would want to at least try to enroll in a clinical trial, instead of going to another country, to help provide proof that it was a good treatment.

I can understand that focusing ultrasound to burn out a region of prostate cancer while leaving the rest of the prostate unharmed might have a lower risk of incontinence and ED than surgery or radiation. Since prostate cancer is most often multicentric--with flecks of cancer of different sizes in different parts of the prostate (like a fruitcake)--burning out the larger pieces of cancer that can be seen on ultrasound might leave behind some smaller regions of cancer.

HIFU is a treatment for early prostate cancer. Studies show that over 90% of people with early prostate cancer won't die from it in the first 10 years after they are diagnosed even if they don't get any treatment at all. So, even if a lot of people who get HIFU are doing well 5 or 10 years later, that doesn't prove that it works. It has to be shown that it works better than no treatment, or at least that it works as well as other older treatments. This is done with randomized controlled studies where patients are randomly put into a treatment group or a control group.

When different regulatory agencies or health care systems organize studies to test treatments to see if they are safe and effective, that's a very good thing. When I go to the doctor, and he/she recommends a treatment, I'd want to know that there is good evidence that the treatment will help me, and that the risk of the treatment are clear. Trying to get this information for HIFU will take time, but it's worth it.
_________________
John

notme · Guest

John,
I totally disagree with much of what you said.

First, I'd go to Mexico before enrolling in a study, A. the doctors in the trials have only done a few procedures, while the doc who goes to Mexico has done over 700. B. the guy who goes to Mexico is motivated to get it approved, he is risking his practice and license in this country, so he is extra careful, very cautious. C. I don't think I'd trust a surgeon to do me with HIFU as he probably doesn't want HIFU approved, he would lose a lot of money changing from surgery to HIFU. And D. the doc who goes to Mexico has sent me 4 questioneers, 6 pages asking how I am, he is devoted to success, he won't do anyone who it might not work on, so I felt safe.

As for long term....frankly, I'd take a year of no side effects and then get reHIFUed over surgery or radiation anyday. I'd also take a few years no side effects and cancer free over 7 years of torture, shots in the penis, incontinence.....etc.

However, I've been reading everything on the web and I see that HIFU has great records, just a lot of people trying to hold it back. My only motivation is to get it approved here, so everyone--rich and poor can have the benefit of an easy cure. HIFU also has a 57% success rate with high risk, so if I was high risk I'd go HIFU.

If I hadn't the money to go to Mexico then I'd enter into a clinical trial, but I'd call International HIFU and ask for referral to where to go, as they know the more experienced doctors in the trials, they taught all the doctors.

I agree it is wonderful to get these clinical trials finished, but I find very little motivation in them---the trial at Sloan-Kettering only has one fellow in it, and he had to ask to be enrolled. All the trials--the doctors do not mention that you could have HIFU, you must already know about it and ask. And it seems to me that the only way of finding out HIFU exists is right here. The trial in Denver already posted results at PubMed saying they find it successful.

The risk of incontinence is as close to non-existant as possible, one study showed one guy out of 172 had to wear pads.

Also, yes, HIFU is capable of only cooking the cancerous part of the gland and leaving the rest, but what is the logic in this? I have a friend who did just that, and now he is questioning his sanity, for the rest of his life he will need to be tested and biopsied as he still has a full gland. As long as my PSA stays low and stable I am home free. But, no matter what course of action that one takes he will worry forever if it will come back, I read a 35% recurrance rate for surgery and 25% for radiation....and 6% HIFU.

I still question why all the trials and tests for ultrasound approval, when radiation, which works by altering the DNA, was approved without any studies.

John M · Experienced user Joined: 27 Jul 2009 Posts: 59

HIFU may turn out to have fewer side effects than many other treatment methods, but it can cause problems with urinary incontinence and ED in some--that shows up in published series from Europe.

If you really believe in this method, wouldn't you want there to be proof that it works for prostate cancer--that if you get it, that your chances of one day getting sick and dying from prostate cancer are less than if you got no treatment, and similar to the chances if you got some other treatment like surgery or radiation? If that kind of proof was out there, insurance would pay for it in every country, everyone with early prostate cancer would want to be treated that way, and urologists everywhere would be experienced and skilled in using it. If you believe in HIFU, why wouldn't you want that?

Why don't you look it up...go to Pubmed: http://www.ncbi.nlm.nih.gov/pubmed/ Do a search on "HIFU prostate". See if you can find any controlled studies that compare HIFU to no treatment, or to another treatment, in order to show that it prevents illness or death from prostate cancer. See what you can find.
_________________
John

notme · Guest

Why doesn't insurance pay for it because it's so cheap? There's the question with the mind boggling answer---a friend of mine who is on The Board of Directors for a well respected NY hospital told me the answer---because the AMA tells insurance companies what to pay for. There's more money for the industry in surgery and radiation.

Does surgery offer better results than doing nothing? does radiation?

At least with HIFU you can do a repeat.

YES! I want proof! I want the clinical trials to go on and get results, I just don't want to be their guinea pig.

Here's a study, from 2006, with more experience--the results are better by now:

http://hifu.wordpress.com/2006/11/01/outcome-analysis-of-high-intensity-focused-ultrasound-for-clinically-localized-prostate-cancer-in-japan/

Nov. 2006

Materials and Methods
This series comprises 340 patients who were treated with Sonablate® HIFU devices (Focus Surgery, IN, USA) patients with a minimum follow-up of one year. During follow-up, prostatic biopsies and PSA level measurements were performed to determine the failure as 3 consecutive rises in the PSA according to the ASTRO definition. None of the patients received androgen deprivation prior to documenting biochemical failure. Kaplan-Meier curves and log-rank test were used for analysis.

Results
The median age and PSA level were 68 years (range 45-89) and 9.5 ng/ml (range 3.1 to 154), respectively. Stage was attributed as follows: T1c in 173, T2a in 106, T2b in 47 and T3 in 14 patients. The median follow-up period for all patients was 23.2 months (range 3 to 86). The biochemical disease-free survival (bDFS) at 5 years in all patients was 70%. The bDFS at 5 years for patients with low, intermediate and high risk groups were 90%, 65% and 57%, respectively (p<0.0001). The bDFS at 5 years for patients with PSA less than 10 ng/ml, 10-20 ng/ml and more than 30 ng/ml were 88%, 68% and 17%, respectively (p<0.0001). 78% had negative biopsies from a mean of 6 cores 6 months after HIFU.

Conclusions
HIFU appears to be both an effective and well tolerated procedure for men with localized prostate cancer.
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I fall into the 90% group of cancer free in 5 years. That suits me fine! I'm an optomist!

John M · Experienced user Joined: 27 Jul 2009 Posts: 59

There is money involved in ALL these treatments, including HIFU. Wouldn't you want treatment decisions to be based on evidence, not on money?

There is a large randomized controlled study of 695 patients randomized to surgery vs no treatment, which now has 12 years of followup published--see my post, "What does it all mean?". There are also other kinds of controlled comparative studies for radiation treatment.

The study you show is an example of short term followup of an group of patients treated with HIFU with no comparison group. Having a low PSA or a negative biopsy doesn't mean that the cancer is gone for ever, just that you are unable to detect it at that time. Will HIFU treatment mean that you have a chance of being alive and well in 10, 15, 20, or 25 years, which is higher than the chance of being alive and well if you had no treatment at all? Who knows? Is there any other outcome that really matters?
_________________
John

Jean222 · Senior User Joined: 14 Dec 2008 Posts: 262

notme,

Your link does not lead to a scientific study, but to a pro-HIFU site that suggests it can be used for a wide variety of tumours, without studies to back their claims.

Although they state stats and apparently good results, where is the link to the proper study?

I'd be interested to see if it's double-blinded, peer reviewed material, in a respected journal.

I'm a bit skeptical of information given on a PRO-anything site, unless they're a lot more specific about *where* they got their stats, studies, etc.

As for 5 year outcomes, that's not long enough for respected medical professionals. It's considered short-term and has not been compared to accepted therapies.

After all, being 2009 yet they still cannot tell if surgery or radiation is the better choice for PCa 'cures'. And those have been studied, properly, for years.

Until proper studies are completed, the jury is out on HIFU.

Best wishes,

Jean

notme · Guest

HIFU has been done for 18+ years in Europe, if it didn't work there would be people screaming it. I have several doctor friends over there (Austria, Germany and Switzerland) who say it does work, they know men who had it done years ago.

You guys all doubt it, and wait for 30 years while the "jury is out" ~ meanwhile I am living free from pads, shots, pills.....and I know 8 guys in Europe who are all fine with a PSA of 0.1 after 8 years time. If it didn't work Dr. Scionti would not be doing it.

Funny, Proton Beam therapy is approved in the USA---no trials done, and it costs $175,000. to $275,000.

HIFU will only be approved when thousands of us are leaving the country.

Jean, Here is what you wanted from PubMed :

http://www.ncbi.nlm.nih.gov/pubmed/16336329

Uchida T, Ohkusa H, Nagata Y, Hyodo T, Satoh T, Irie A.
University of Tokai Hachioji Hospital, Hachioji, Japan. tuchida@green.ocn.ne.jp

OBJECTIVE: To evaluate the biochemical disease-free survival (DFS), predictors of clinical outcome and morbidity of patients with localized prostate cancer treated with high-intensity focused ultrasound (HIFU), a SCAM treatment that induces complete coagulative necrosis of a tumour at depth through the intact skin.
PATIENTS AND METHODS: In all, 63 patients with stage T1c-2bN0M0 localized prostate cancer underwent HIFU using the Sonablate system (Focus Surgery, Inc., Indianapolis, IN, USA). None of the patients received neoadjuvant and/or adjuvant therapy. Biochemical recurrence was defined according to the criteria recommended by the American Society for Therapeutic Radiology and Oncology consensus definition, i.e. three consecutive increases in prostate-specific antigen (PSA) level after the nadir. The median (range) age, PSA level and follow-up were 71 (45-87) years, 8.5 (3.39-57.0) ng/mL and 22.0 (3-63) months, respectively.
RESULTS: The overall biochemical disease-free rate was 75% (47 patients). The 3-year biochemical DFS rates for patients with a PSA level before HIFU of <10>20 ng/mL were 82%, 62% and 20% (P < 0.001), respectively. The 3-year biochemical DFS rates for patients with a PSA nadir of <0>1 ng/mL were 100%, 74% and 21% (P < 0.001), respectively. Final follow-up sextant biopsies showed that 55 (87%) of the patients were cancer-free. Multivariate analysis showed that the PSA nadir (P < 0.001) was a significant independent predictor of relapse.
CONCLUSION: HIFU therapy appears to be a safe, effective and minimally invasive therapy for patients with localized prostate cancer, and the PSA nadir is a useful predictor of clinical outcome.

PMID: 16336329 [PubMed - indexed for MEDLINE]
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How can you doubt HIFU works when it induces complete coagulative necrosis of a tumour at depth through the intact skin.?

notme · Guest

I copied the story from the CBC news article that Jean started this post with, as it will soon go away from that web site, here it is:

Some men with prostate cancer are paying for a new treatment to target cancer cells called high intensity focused ultrasound, which is less invasive than surgery or radiation.

HIFU, which was developed in the United States about 10 years ago, is a computer-controlled probe that is inserted into the rectum and emits ultrasound beams inside the prostate where it creates enough heat to destroy targeted tissue.

A few months ago, Ken Morris was diagnosed with early-stage prostate cancer and elected to undergo the procedure at a private clinic in downtown Toronto that offers the less-invasive treatment.

"That was one of the first qualities of HIFU that attracted me to it," he said. "No cutting, no stitching."

Morris was a candidate for the procedure because his cancer was not aggressive. He was sold on the promise of fewer side effects commonly associated with prostate surgery despite the hefty $20,000 fee.

"The likelihood of erectile dysfunction seems to be somewhat lower," said Dr. Laurence Klotz, a urologist at Sunnybrook Health Sciences Centre in Toronto. "We can do a nerve-sparing HIFU treatment, which really doesn't treat the nerves at all, and the rate of incontinence or difficulty controlling the urine also seems to be significantly lower than with surgery."

About 7,000 men around the world have undergone the treatment. Early studies suggest most patients emerge cancer-free but there is very little extensive, long-term data.

Dr. Joseph Chin, a urologist at London Health Sciences Centre in London, Ont., is doing a clinical trial using HIFU and looking at whether it is safe, effective and extends the lives of men for whom radiation therapy hasn't worked.

"We really need to go for up to five years, 10 years, before we know long-term … whether these patients are 'cured,'" he said.

After recently undergoing the procedure, Morris said HIFU was the best choice for him.

"I'm very pleased that I'm feeling so good, sitting at my house, talking to you normally right now," he told CBC News. "That's one thing I didn't expect. I expected to feel a lot worse."

Morris won't know for weeks whether he is free of cancer, but he said he has no regrets about his decision to try HIFU.

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In my looking around on the web, I find that HIFU was invented in Indiana in 1941 by a urologist who went through surgery for prostate cancer. Then in 1970 it re-emerged, the French made their own machine and started using it in 1990.

Putt · Regular Joined: 04 Aug 2009 Posts: 36 Location: Kansas

notme

Since it was only 5 months between the procedure and your last PSA test, what leads you to believe you are cancer free? You have yet to reach the undetectable level (0.05) for at least 12 months straight, which is considered by most well known Oncologist to be that point in time when the patient can consider his PC under control, but must continue to be aware of possible reoccurance.
_________________
PSA at Dx 105 at age 68, 4/04. ADT, RRP, 5/04. Gleason 4+5=9, Staged pT3c N0 MX, 3D rad, 40 treatments, 8/04. PSA 1/05 <0.01. ADT till 7/07. PSA 0.03 12/08, 0.07 4/09, 0.13 8/09, 0.19 12/09. Will start ADT3 after PSA reaches 1.2.

notme · Guest

Yes, yes, Putt, I know, just like everyone else who has had any procedure I must have my PSA tested. But with a 94% cure rate am relaxed about it, I just want other men to know their is another option.

And, my PSA number is fantastic for a 5 month PSA after HIFU, the number should come down at 9 months. Never as low as what you posted, 0.1 for HIFU is what I think is spot on, as I still have the gland just no tissue in it.

I'll report whatever happens, as honesty is what will make the world keep going around.
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Laughing

Look at what I found: THIS IS AMAZING!! : Laughing

Non-invasive brain surgery proves successful. June 25, 2009

Not many patients can imagine having a glass of champagne with their surgeons straight after brain surgery but that is exactly what is happening at a Zurich hospital.

Swiss doctors have successfully carried out the world's first non-invasive brain surgery with use of high-intensity focused ultrasound (HIFU).

Ten adult patients, who were awake during the revolutionary painless procedure, have been treated at University Children's Hospital Zurich since September 2008 as part of a clinical study. The results were published this week.

All interventions were completed successfully and without complications under the direction of professors Daniel Jeanmonod and Ernst Martin.

"This fully non-invasive procedure opens new horizons for neurosurgery and the treatment of different neurological brain disorders," Ernst Martin, director of the hospital's Magnetic Resonance Centre told swissinfo.ch.

The list of diseases and conditions which could be treated with this safe and effective technique includes Parkinson's, Alzheimer's, epilepsy, brain tumour and stroke.........

.......HIFU has been used for some years in the treatment of uterine fibroids and tumours of the prostate gland. The ultrasound beams heat up the problem area, creating a lesion and rendering it inactive.

This is the first time that the technique has been applied to the brain through the intact skull for non-invasive neurosurgery........

read the rest of the article here:
http://www.swissinfo.ch/eng/science_technology/Non_invasive_brain_surgery_proves_successful.html?siteSect=511&sid=10873250&cKey=1246694898000&ty=st

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