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Old 08-26-2010, 09:11 AM   #1
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HIFU - New Guidelines from Canada

HIFU - High Intensity Focused Ultrasound - has been an approved therapy in Canada for some time now. A Canadian medical organization has issued a "Practice Guideline" on HIFU. The organization is the Genitourinary Cancer Disease Site Group of Cancer Care Ontario’s Program in Evidence-Based Care. The Guideline was published in the August 2010 edition of the Canadian Urology Association Journal, Volume 4, Issue 4.

I have not had a chance to read the guideline itself, but I've seen a review. The review highlights this conclusion, with quotation marks indicating its taken directly from the guideline: “HIFU cannot currently be recommended as an alternative to accepted curative treatment approaches for localized prostate cancer.” However, as with so many official groups, the organization is looking for "well-designed" clinical trials matching HIFU against standard approaches before it will recognize HIFU as a standard therapy.

Frankly, that's a tough standard to meet for any therapy, including existing ones. The organization is calling for HIFU to be used only in clinical trials or in other investigational circumstances where other treatments are not suitable for a patient. I'm looking forward to learning what they think about HIFU's effectiveness based on their review of 29 HIFU studies.

The guideline does give a brief summary of its view of HIFU side effects, based on the 29 studies. The quotation is from the guideline: “The common complications (medians [JIM here: means half do better, half do worse] associated with HIFU [REVIEW here: when used as a first-line treatment] included impotence (44% among previously potent patients), urinary tract infections (7.5% of patients), urethral stricture (12.3%), stenosis (7.8%), urinary incontinence (8.1%), urinary retention (5.3%), chronic perineal pain (3.4%) and urethrorectal fistula (1.0%).”

 
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Old 08-26-2010, 04:58 PM   #2
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Re: HIFU - New Guidelines from Canada

Hi got,

I have now read the paper, and I'll be posting about that, but I'll respond to some of your points below in green.


... These stats are really awful, guess the message is to make sure your doctor is well experienced.

I was disappointed when I read the paper regarding the statistics for effectiveness because the guidelines did not sort out the low-risk men, thereby making HIFU look less effective. I'll post about that separately.

Regarding side effects, even though the number for impotence at 44% (for men who were previously potent) was a lot higher than some of us expected, it's probably at least competitive with numbers for some other therapies. If you are hoping that other side effect scores will be near zero, it's easy to understand your disappointment. However, several of those percentages look pretty good compared to other treatments, such as that incontinence number of just 8.1%. One notable study puts those numbers at 24 months at about 31% for non-nerve sparing RP, 9% for nerve sparing RP (yes, I know we're talking incontinence, but the nerve sparing procedure seems to make a difference), 15% for brachytherapy, and about 21% for EBRT (Talcott JA et al, JCO 21:3979, 2003). By the way, the same study puts the sexual dysfunction scores at two years at about 68% for RP, about 69% for EBRT, and about 45% for brachytherapy; the timeframe matters and was not addressed in the new guideline, but HIFU would lead the pack with the least sexual dysfunction at 44%, nudging out brachytherapy. When we talk to newly diagnosed patients about HIFU, it seems to me that the side effect profile is an advantage.

Personally, I like the side effect profile for HIFU as it is emerging from research. It's the effectiveness side that is still a question mark for me. In all of this though, it's clear that a majority of men are doing fine with HIFU, and your husband is in that group.

I like your point about selecting an expert doctor.


Even if I had read of these scare tactics I wouldn't have changed my mind, HIFU has the least chance of something awful happening.

I realize that doctors are not happy about the prospects of HIFU being approved.

I'm hoping this guideline work was objective, but "marketing" influences are strong in prostate cancer, and it's possible we are seeing some "sharp elbows" being thrown in the struggle to get patients, rather than complete objectivity. I was surprised that the guideline focused on overall results rather than results with low-risk men. To me that does not make the best sense, as HIFU is a local therapy (focused on just the prostate) and would naturally not do as well with cases where there's a good chance the cancer has already escaped, in other words, in intermediate and high-risk cases. Yet the average Gleason in the total of all these studies was "less than or equal to" 7, implying a substantial number of intermediate risk men, where HIFU would not do as well - would not be playing to its strength. That absence of a comment on performance with low-risk men may be a sign of a subtle, possibly subconscious, bias against HIFU, but there is no way of telling.

[moved to the end by Jim] The recommendation to restrict HIFU to clinical trials is simply funny ~ as the best results are coming from the doctors with the most experience and clinical trail doctors don't have the experience....they won't even accept doctors with a lot of experience in them!

You can ease your concern on that score. As far as I know, there is no bias against having experienced doctors in clinical trials. I believe the reverse is true, that experienced doctors have greater chances of getting grants for research.

That said, I'm concerned that the Ontario organization is looking for "well-designed clinical trials." That technical language means a trial where you enroll participants, treat them and report results (a "prospective" trial rather than one that examines records), that includes both experimental and control groups (such as HIFU as experimental versus another group getting an accepted therapy like brachytherapy), but no randomization. (Randomization, while it is ideal for statistical analysis, is really tough to implement with high compliance due to ethical issues and patient choices.) Due to the long typical survival of prostate cancer patients, a long period of follow-up is necessary if survival is the key to score keeping. Often another score keeper is used, such as freedom from recurrence, and that can slice many years off the study follow-up timeframe, though it still takes a lengthy period. I'm concerned because such well-designed clinical trials are difficult to pull off and take a long time. I would prefer to see approval based on soundly done clinical series. While that would give you a somewhat weaker quality of evidence, such evidence is a whole lot easier and faster to get. We would have usable results many years earlier.

Looking for evidence at least as strong as "well-designed clinical trials" is quite standard for groups like the Ontario group, but it does set a high hurdle for newcomer therapies like HIFU. I don't think that's fair.

Jim

 
Old 08-26-2010, 06:01 PM   #3
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Re: HIFU - New Guidelines from Canada

Some more detail on the guidelines now that I've read them:

The Ontario group behind the guidelines is a medical association group, apparently, independent of the Government, but was supported with funds by the provincial Government of Ontario.

They looked at 29 studies, with 6,912 patients, but some of the patients likely were counted in a number of studies.

Follow-up biopsies were usually done at 3 to 6 months after treatment.

Five year recurrence free survival rates in five series ranged from 55% to 95%; I suspect the risk levels of patients in the series varied quite a bit.

Most of these patient had HIFU and nothing else.

Retreatment, noted in 11 series, ranged from 7.7% to 43%. Side effect rates increased after retreatment.

Supportive hormonal therapy and TURPs were done for some patients, but hormonal therapy was stopped for all patients prior to HIFU.

The longest series, with 140 patients and averaging 6.4 years of follow-up, "reported a negative biopsy rate of 86.4% and a 5-year disease-free survival rate of 66%." However, without knowing the risk levels of patients, that rather low percentage does not mean much to me.

Use of HIFU as salvage therapy was also addressed.

The list of references looks useful, but it appears the study was in review without getting into new studies about 2009.

Jim

 
Old 08-28-2010, 03:40 PM   #4
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Re: HIFU - New Guidelines from Canada

I looked up the recent French and Japanese papers that have included longer follow-up than was reported in the Canadian guideline as well as including specific results for men with low-risk case characteristics. This is what was covered about the guideline's coverage of effectiveness against cancer in the previous post, and I'll add the information about the French and Japanese studies at the end in green.

"...

The longest series, with 140 patients and averaging 6.4 years of follow-up, "reported a negative biopsy rate of 86.4% and a 5-year disease-free survival rate of 66%." However, without knowing the risk levels of patients, that rather low percentage does not mean much to me.

...
The list of references looks useful, but it appears the study was in review without getting into new studies about 2009...."

Where the guidelines reported that overall "5-year disease-free survival rate of 66%," in the longest series looked at by the study group, the French study (published in mid-2010), based on results from six different treatment centers, reported that its low-risk patients had disease-free survival rates of 83% at five years of follow-up and 75% at seven years of follow-up. The Japanese study (published in late 2009) reported a virtually identical rate of 84% for low-risk patients at five years of follow-up.

It appears that risk level makes a difference, with the French and Japanese figures converging on a much better figure than the overall figure of 66% reported in the guideline.

The sources for the French and Japanese studies:

Crouzet S, ... Gelet a, "Multicentric Oncologic Outcomes of High-Intensity Focused Ultrasound for Localized Prostate Cancer in 803 Patients," European Urology, 2010 July 3.

Uchida T, ... Nagata Y, "Transrectal high-intensity focused ultrasound for the treatment of localized prostate cancer: eight -year experience," International Journal of Urology, 2009 Nov.

Jim

 
Old 09-10-2010, 07:58 AM   #5
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Re: HIFU - New Guidelines from Canada

So, here I am, 44 years old, generally good health, 12 positive biopsies, Gleason 3+3=6, Stage 1 (I have an appt. with my urologist today to get clarification on the stage info, I know it's incomplete). I am seriously considering driving up to Toronto to get HIFU. I think there is strong financial bias here in the U.S. and want the least intrusive, most effective treatment possible. How can I find out what doctors have the most experience and highest success rates for this "alternative" treatment? Any input will be greatly appreciated.

 
Old 09-10-2010, 09:17 AM   #6
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Re: HIFU - New Guidelines from Canada

Quote:
Originally Posted by john52il View Post
...want the least intrusive, most effective treatment possible.

Hi John, from a fellow Chicagoan (well, I'm from NW of Chicago), and welcome. I noted a sense of urgency in your two postings from this morning, and wanted to let you know that usually (not always, but usually) one is not in a huge rush to treat prostate cancer (PC)...which is unlike many other cancers in this regard. One's biopsy details can give good insight (not perfect insight) into whether the cancer is likely caught early and slow moving (those often go together), or if it is more advanced. The Gleason score of 3+3 is one good indication of low risk PC, but the way you phrased "12 positive biopsies" has me wondering what you meant.

My guess is that you've had one biopsy, and not 12, but your one biopsy had 12 sample "cores" taken. The biopsy report would also provide information on how many cores had some percent of cancer (and the Gleason results for each core). Did you mean to imply that 12 out of the 12 sample cores were positive for prostate cancer? I'd have to say this would be a little unusual (but not unheard of), especially when the Gleason score 3+3=6 was the overall result.

I might suggest that you clarify with the report and/or with the urologist on how many cores were positive, and what percent of cancer existed in each of the cores with cancer. This will be important information for you to know (and your PSA results over time, and your DRE result) and have at-hand going forward with treatment decisions. I might further suggest that when you come back with that info, you should start your own new thread on this site to detail out your case rather than continuing in this thread on the new Canadian HIFU Guidelines.

Without this additional info it's had to say with much confidence, but most young guys like you (and like me) with 3+3=6 PC do not have an aggressive cancer, and so it is strongly advised (after clarifying one's case details) to educate oneself about all the alternatives, outcomes, side effects, and effectiveness. One can pretty quickly learn a lot and make an informed decision.

You wrote that you "want the least intrusive, most effective treatment possible"...what you might find is that these may not be one-in-the-same. HIFU, which you have inquired about here, is not very intrusive, but if you read the information at the beginning of this thread, even the Canadian government which has approved the procedure does not advocate it as very effective or with low side effects. For this data and any inputs you get on the web and fourms like this, I would recommend looking for reputable sources for verification. We are limited in posting website links on this forum, but perhaps the best possible resource is the www.pubmed.gov which is the online library of the National Library of Medicine. [we can list that link or any .gov link here] In the case of the Canadian report on HIFU, the link was not provided, but the details on where it was published were given instead.

I recommend the book by Dr Patrick Walsh titled "Guide to Surviving Prostate Cancer" to all newcomers to educate themselves on the anatomy of what's going on. It is available via online booksellers, and is considered one of the "bibles" for PC patients like us.

Again, welcome.


------------------------
added later as an edit:
I'm several years older than you, but not too many. I wrote somewhat extensively about my own decision path to treatment, and I thought I would share this link to that posting with you. I'm not intending, in any way, to influence your own decision making, but simply sharing my thought processes in hopes that it might help you clarify your own thought processes. Copy/paste this link:
http://www.healthboards.com/boards/showpost.php?p=4085673&postcount=8

Last edited by kcon; 09-10-2010 at 02:15 PM.

 
Old 09-10-2010, 03:13 PM   #7
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Re: HIFU - New Guidelines from Canada

Hi John,

I responded to your other post on a different thread a few moments ago, but I wanted to add a few thoughts to kcon's very thoughtful comments to you.

You wrote in part:


Quote:
Originally Posted by john52il View Post
So, here I am, 44 years old, generally good health, 12 positive biopsies, Gleason 3+3=6, Stage 1 (I have an appt. with my urologist today to get clarification on the stage info, I know it's incomplete).
I too am puzzled by the extraordinarily high count for positive biopsy cores and the staging of Stage 1. While that's not impossible, it would be rare in my now fairly informed layman's opinion (no enrolled medical education). With twelve cores positive, it would be highly likely that the cancer could be felt, making it at least Stage 2, if not Stage 3. Ask your doctor for a copy of his comments, if he wrote any, and for a copy of your biopsy report. The pathologist should have recorded what percentage of each core was positive, and he or she may have even included Gleason grades and the total score for each.

Quote:
Originally Posted by john52il View Post
I am seriously considering driving up to Toronto to get HIFU. I think there is strong financial bias here in the U.S. and want the least intrusive, most effective treatment possible.
HIFU may turn out to be one of the least intrusive therapies, but is not a cake walk for many men as you can see from the research, especially regarding erectile function - not bad in comparison, but no free ride either.

However, it's the effectiveness in controlling cancer that has many of us concerned. We patients, physicians and the researchers begin to see how effective a treatment is at preventing recurrences of prostate cancer around the five year point. Unfortunately, the statistics on the groups of patients that have been well published, including work by leading HIFU pioneers, are indicating recurrence rates (to use just one measuring rod of success) after HIFU for low risk patients - the patients who should do extremely well - of around 83% in one recent series to 84% in another recent series for patients at the five year point, with the 83% series having success of only 75% as low-risk patients passed the seven year point. Those rates are in stark contrast to rates in the high nineties for brachytherapy practiced by experts, for example, as documented in published research.

Also, patients need to consider another twist in the results picture. We now know that about 70% of low-risk patients in at least the major active surveillance programs will not have to have any major treatment at least for many years, often for the rest of their lives. Therefore, for low-risk patients, a result of 75% non-recurrence at seven years after HIFU does not look like much of an accomplishment when compared to 70% success for low-risk patients without any major intervention!


Quote:
Originally Posted by john52il View Post
How can I find out what doctors have the most experience and highest success rates for this "alternative" treatment? Any input will be greatly appreciated.
There is obviously a lot of hyping going on. Watch out for sources that quote old, more successful results (with fewer years of follow-up) for HIFU when later reports, with more follow-up, with decreased success rates, have been published by the same group of physician researchers. (It's the information clearing-house type sources that are biased, not the honest physician/researchers publishing the reports.)

I would seek personal recommendations (some are on this board), and then follow-up with the doctor to see if he tracks each of his patients for both prostate cancer non-recurrence and for quality of life. If he does, and if he has good five year statistics, or even better, longer statistics, then that's a favorable sign. You could also ask for references (say five, at least) for a given month among his patients with longer time since treatment. For instance, if he does HIFU in the Bahamas for several stints during the year, ask for contact data for five or more patient done within one of those sessions. If he is really good, it's likely, with this rather new therapy, that his patients will be glad to tell about his success.

Take care,

Jim

 
Old 09-10-2010, 05:23 PM   #8
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Re: HIFU - New Guidelines from Canada

Thanks kcon and Jim. To clarify, it was one biopsy, 12 samples, all positive, all 3+3=6. I saw a 2nd urologist today and he basically said, although he considers himself conservative about suggesting surgery, in my case he sees it as the only choice. I agree, from what I've read a Gleason score like mine seems okay, but coupled with 12 cores that are all positive, seems scary. I'm surprised none of the CTs show anything outside and I'm surprised I'm categorized as t1c. I also agree with the idea that prostate cancer is not usually very aggressive, but I feel like mine must have been here quite a long time and is (?) at a point where it's going to spread to other organs, obviously the last thing I want to happen. Please add any more feedback you can. It is greatly appreciated. I have pretty much ruled out seed implants or HIFU after what he told me today.

John

 
Old 09-10-2010, 07:23 PM   #9
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Re: HIFU - New Guidelines from Canada

Hi again John,

I'll insert a couple of thoughts in an excerpt from your latest post, in green.


Quote:
Originally Posted by john52il View Post
Thanks kcon and Jim. To clarify, it was one biopsy, 12 samples, all positive, all 3+3=6. I saw a 2nd urologist today and he basically said, although he considers himself conservative about suggesting surgery, in my case he sees it as the only choice.

In my layman's opinion, but an informed one, I believe you got quite a sales pitch there without much research to back up what the doctor said. Frankly, I find that incredible.

I agree, from what I've read a Gleason score like mine seems okay, but coupled with 12 cores that are all positive, seems scary. I'm surprised none of the CTs show anything outside and I'm surprised I'm categorized as t1c.

You haven't mentioned your PSA yet, but the CT is a rather insensitive test that extremely rarely shows any spread for cases thought to be low-risk; in fact, CTs are typically negative even for many intermediate cases. My CT was negative, despite my PSA of 113.6, my biopsy with all cores postive - most 100% cancer, GS 4+3=7, and perineural invasion.

Yes, that T1c is surprising. You should get a copy of that biopsy report.


I also agree with the idea that prostate cancer is not usually very aggressive, but I feel like mine must have been here quite a long time

That's overwhelmingly the case for prostate cancer patients, even many low-risk patients. Don't feel lonely.

and is (?) at a point where it's going to spread to other organs, obviously the last thing I want to happen.

That may not be so at all, and there are ways to smoke out the real situation.

Please add any more feedback you can. It is greatly appreciated. I have pretty much ruled out seed implants or HIFU after what he told me today.

John
I understand ruling out HIFU, but to me as a layman seeds would still be a very live option based on what you said, except in very limited circumstances. In the hands of experts, radiation from seeds can reach a few millimeters beyond the prostate as well as doing a thorough job within it, and that's often good enough to get the most likely spread of cancer cells. There could be an issue, favoring surgery, if the cancer were right along the urethra, which is typically avoided in seed therapy, as I understand it.

Can you describe why the doctor ruled out seeds?

Take care,

Jim

Last edited by IADT3since2000; 09-14-2010 at 02:31 PM. Reason: Deleted brief comment at end after reviewing posting rules.

 
Old 11-07-2010, 06:35 PM   #10
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Re: HIFU - New Guidelines from Canada

Quote:
Originally Posted by john52il View Post
So, here I am, 44 years old, generally good health, 12 positive biopsies, Gleason 3+3=6, Stage 1 (I have an appt. with my urologist today to get clarification on the stage info, I know it's incomplete). I am seriously considering driving up to Toronto to get HIFU. I think there is strong financial bias here in the U.S. and want the least intrusive, most effective treatment possible. How can I find out what doctors have the most experience and highest success rates for this "alternative" treatment? Any input will be greatly appreciated.
Hi John:

I had a salvage HIFU performed in Janauary 2010 in Toronto. My prostate cancer recurred after initial radiation therapy in 2007. I'm currently seeing Dr. Lawrence Klotz whose reputation is second to none when it comes to matters relating to Pca. Dr. Klotz is also a partner in a clinic that provides HIFU on a fee for service basis. The current charge is $22,000 per procedure.

Dr. Klotz is also a strong proponent of active serveillance
and has assembled impressive data that indicates that there is little difference if active treatment is delayed until the individual clinical picture dictates a change in direction. I think that you have many options at your disposal considering that your Gleason score is a 6.

All the best,
Dan

Last edited by moderator2; 11-07-2010 at 06:48 PM. Reason: please do not direct off board searches

 
Old 11-07-2010, 08:29 PM   #11
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Re: HIFU - New Guidelines from Canada

I also had a lot of positive cores -- 10/12 cores positive, with about 10% cancerous, Gleason 3+3, Stage T2a and PSA of 7.3. Age 57. I narrowed it down to 4 choices:

High Dose Rate (HDR) Brachytherapy - this is different from seeds (Low Dose Rate) in that highly radioactive needles are placed in the prostate and held there for several minutes only rather than being left in permanently. Toxicity is very low, and cure rate is very high.

Hypofractionated Stereotactic Body Radiation Therapy (SBRT)- This is often called CyberKnife, although mine was delivered thru RapidArc. Both this and HDR brachy work so well because PC cancer cells are killed better with the higher doses than with more lower doses, as with IMRT or seeds.The word "hypofractionation" means fewer fractions- the dose is delivered in fewer sessions: 4 or 5 with CyberKnife vs 44 for IMRT typically.

Protons - interestingly, Loma Linda has a hypofractionated clinical trial right now of 20 sessions instead of the 40+ sessions. More proton centers are in the works. Very accurate delivery of very powerful radiation. Very good results.

RP- the advantage is they can check for clear margins as they remove it, and they can accurately grade the cancer.

In my opinion, all of the above do a good job in getting rid of the cancer completely. If you have a good surgeon and you're lucky, RP is fine. Lucky means nerves supplying your penis and your urinary sphincter are not cut or shocked, the cut through the urethra heals well, and the margins are clear. I also did not like that when they cut and reattach your urethra, it pulls back on your penis, shortening it.:-(

CyberKnife does as good if not better job compared to HDR brachy and protons. They typically irradiate a couple of centimeters beyond the prostate capsule and gets to places surgery cannot. Dose to surrounding structures is minimal (that's the "stereotactic" part). Five short sessions and I was done. Also, I was able to get the best Radiation Oncologist in the world, Chris King. That played a big factor.He has five years of experience which will be published shortly -- the results are excellent.

So far, after a month after treatment, no genitourinary problems (and no shrinkage!). Late term effects may crop up in a year or two, but if Dr King's stats hold, odds are that there will be none.

I talked to three doctors and did a lot of research before deciding -- it took six months until I finally took the plunge. I know it's scary to wait -- "What if it spreads?" But it's usually slow growing. You are beyond the AS stage, but I hope you will take the time to investigate.

- Allen

 
Old 11-30-2010, 08:21 PM   #12
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Re: HIFU - New Guidelines from Canada

Hi John:

I had a HIFU procedure done in Toronto in January 2010. As I was part of a clinical Study I didn't pay the current fee of $22,000 for the procedure. In Toronto there are two independent clinics offering HIFU treatments. You can Google HIFU Clinics & Toronto and the names of both will pop up.
Probably the foremost authority on prostate cancer in Toronto (and Canada) is Dr. Lawrence Klotz. Unfortunately, I'm unable due to the strictures of this site to give you either his Hospital affiliation and/or contact information. Again you can Google Dr. Klotz and there will be numerous references to his research endeavours, plus contact information. Dr. Klotz also runs an extensive active surveillance program for patients with early stage cancers and moderate Gleason scores. He is also affiliated with one of the two HIFU centres in Toronto and has personally performed over 80 HIFU procedures. For purposes of full disclosure, Dr. Klotz is also my personal oncologist. He is simply brilliant-yet a warm and approachable professional who is totally committed to securing the best of clinical outcomes for the patients that he is providing care for.
Much good luck!
pretty12d

 
Old 11-10-2011, 03:10 PM   #13
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Re: HIFU - New Guidelines from Canada

Thank you. Very helpful comments regarding the Cyber Knife which I am also considering. In case of failure what vialbe alternatives are available for further treatment?

 
Old 11-10-2011, 03:34 PM   #14
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Re: HIFU - New Guidelines from Canada

I've read about cases of CK re-treatment based on local failure. IGRT, Brachy, cryo, and HIFU are possible salvage therapies too. There are surgeons who specialize in radiation salvage. But as my Uro said to me, you don't base your choice of therapy on what happens if it doesn't work when the odds are over 90% that it will be curative.

Last edited by Tall Allen; 11-11-2011 at 12:54 PM. Reason: I left out brachy as salvage

 
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Proton Beam Versus HIFU Ultrasound Which Is Better? builder Cancer: Prostate 3 09-28-2008 06:48 PM
Proton Beam Therapy??? corynski Cancer: Prostate 59 09-28-2008 06:33 AM




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