CBC take on HIFU....

srtimmons · Posted: Tue Aug 25, 2009 9:44 am Post subject: notme

Notme - I appreciate your confidence in your HIFU solution and I do hope you are totally cured. However, people come to this Board fighting for their lives or extremely concerned for loved ones and they need objective, unbiased advice.

We need to make sure that objective information is presented. HIFU is not a silver-bullet and should never be presented as such. It may work for some, but is not appropriate for others.

There is a reason that the FDA has not approved it in the U.S. and it is not for financial reasons or some conspiracy.

Time will tell as more empirical data comes in on cure rates and recurrence rates.
_________________
Age 58
Dx 6/15/2009; PSA 7.1; 7/12 cores positive; Gleason 6 (3+3) and 7 (3+4); PNI observed. Bone Scan and CT scan negative.
Robotic RP 7/20/2009

Path report 8/11/2009 - clean margins, negative lymph nodes, negative seminal vesicles, Gleason 3+4, Stage T2c; 15% of prostate involved; NoMx.

PSA .006 September 2009
PSA .005 November 2009
PSA .005 February 2010

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

Here is the summary assessment on current evidence on HIFU from the European Association of Urology 2009 Prostate Cancer Guidelines:

11.3 High-intensity focused ultrasound (HIFU)
HIFU consists of focused ultrasound waves emitted from a transducer to cause tissue damage by mechanical and thermal effects as well as by cavitation (15). The goal of HIFU is to heat malignant tissues above 65 °C in order to destroy them by coagulative necrosis. HIFU is performed under general or spinal anesthesia, with the patient in the lateral (Ablatherm®) or supine (Sonablate® 500) position; the procedure is time-consuming, with about 10 g prostate tissue being treated in one hour. In a recent review, 150 papers related to HIFU were identified and evaluated with regard to various oncological and functional outcome parameters (12). No controlled trial was available for analysis, and no survival data were presented. No validated biochemical, surrogate end-point was available for HIFU therapy.

11.3.1 Results of HIFU in PCa
As with CSAP (Cryosurgery of the prostate), it appears to be difficult to interpret oncological outcome in patients undergoing HIFU since various PSA thresholds are defined and no international consensus exists on objective response criteria. The results of HIFU are limited, with outcome data from fewer than 1000 PCa cases having been published in the literature. According to the recent review paper mentioned above (12), HIFU showed progression-free survival (based on PSA +/- biopsy data) of 63-87% (projected three- to five-year data), but median follow-up in the studies ranged from 12-24 months only. In one of the largest single-centre studies, 227 patients with clinically organ confined PCa were treated with HIFU and their outcome data were analysed after a mean follow-up of 27 months (range = 12-121 months) (16). The projected five-year biochemical disease-free survival was 66%, and or only 57% if patients had exhibited a pre-therapeutic PSA value of 4-10 ng/mL. Incontinence and bladder neck stricture decreased over time from 28% and 31% to 9% and 6%, respectively. In one of the studies (17), a significant decrease in pre-treatment PSA serum levels from 12 ng/mL to 2.4 ng/mL was observed. However, 50% of the 14 patients demonstrated positive prostate biopsies during follow-up. In another study (18), a complete response rate defined by PSA < 4 ng/mL and six negative biopsies was achieved in 56% of the patients. Summarising the efficacy results of a European multicentre study comprising the data of 559 patients with mainly low- and intermediate-risk PCa, Thüroff et al. (18) reported on a negative biopsy rate of 87.2% in 288 men with a follow-up of at least six months. A PSA nadir after six months follow-up could be determined in 212 patients, and it was as high as 1.8 ng/mL. However, it could be demonstrated that the PSA nadir might be reached at 12-18 months following the initial procedure. Blana et al. reported on 146 patients undergoing HIFU with a mean follow-up of 22.5 months (19). The mean PSA level at initiation of therapy was 7.6 ng/mL; the PSA nadir achieved after three months was 0.07 ng/mL. However, after 22 months the median PSA level was 0.15 ng/mL. Of the 137 men available for analysis, 93.4% demonstrated a negative control biopsy. The PSA nadir appears to be strongly associated with treatment failure (20) (p < 0.001). Patients with a PSA nadir of 0.0-0.2 ng/mL have a treatment failure rate of only 11%, compared with 46% in patients with a PSA nadir of 0.21-1.00 ng/mL, and 48% with a PSA nadir of >1.0 ng/mL. Recently, the group updated its results, with a total of 163 men treated for clinically organ-confined PCa. Within 72 Update march 2009 the 4.8 +/- 1.2 years of follow-up, the actuarial disease-free survival rate at five years was 66%, with salvage treatment initiated for 12% of the patients (21).

11.3.2 Complications of HIFU
Urinary retention appears to be one of the most common side-effects of HIFU, developing in almost all patients, with the mean interval of catheterisation via a suprapubic tube varying between 12 and 35 days (15-17). Grade I and II urinary stress incontinence occurs in about 12% of patients. Subsequent TURP or bladder neck incision to treat subvesical obstruction is common, and is sometimes even performed at the time of HIFU. Post-operative impotence will occur in approximately 55-70% of patients.

11.5 Summary of experimental therapeutic options to treat clinically localised PCa
• CSAP has evolved from an investigational therapy to a possible alternative treatment for PCa in patients who are unfit for surgery or with a life expectancy < 10 years
• All other minimally invasive treatment options – such as HIFU, RITA, microwave and electrosurgery – are still experimental or investigational. For all of these procedures, a longer follow-up is mandatory to assess their true role in the management of PCa
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John

Marathon Man · Posted: Tue Aug 25, 2009 2:39 pm Post subject: Re: CBC take on HIFU....

[quote="notme"]
I am not a doctor, just an interested experienced user.[/quote]
Yet you then proceed to, imho, selectively "answer" the findings of medical professionals. I'm sorry, but I just don't accept that your opinion weighs heavily in this matter.

What I look for is substantiated evidence. While researching HIFU, I've come across quite a deal of evidence on both sides of the debate, including a lot of industry and media claims on the efficacy of HIFU. Currently, at best, HIFU is considered a procedure in its infancy.

[quote="notme"]You can buy Cialis (tadalafil) at AllDayChemist.com for $1. a pill.[/quote]Yes I'm aware that you can buy generic drugs from India. When I buy generic drugs, I prefer to buy them in an environment that I know is regulated to the level that I expect.

Particularly in view of the fact that so many people come to this site looking for good information (one of the prime things that attracted me here), I'm prepared to discuss and debate matters when we can back up claims. I think you are exceedingly selective in your information, therefore I don't intend discussing it further with you, elevating profile of the posts. I'm out.
_________________
Marathon Man

PSA May 06, then 6 monthly; 4.3-4.9-6.8, Dx Feb 2008, PSA 9.4 @age 54 - Biopsy Gleason 4+3
RRP 22 May 2008 - Gleason 4+4, Tumour Vol 5%, T2a, N0M0, Negative Margins. Aug 08, PSA <0.01, Feb 09 <0.02, Sep 09 <0.02, Mar 10 <0.02

http://prostaterunner.blogspot.com/ Irregularly updated & months behind!

notme · Guest

Yes, I was one of those men looking for advice from people, not doctors when I came here. That's why I am here, as all this old data, or data from inexperienced doctors is out there, and it seems men who had the standard treatment are against HIFU. I think you guys are exceedingly selective in your information.

So I am offering my experience, and along with it I also am privy to my friends who had HIFU, and we haven't experienced any of the complications that are readily available on the web....like this:

"Complications of HIFU
Urinary retention appears to be one of the most common side-effects of HIFU, developing in almost all patients, with the mean interval of catheterisation via a suprapubic tube varying between 12 and 35 days (15-17). Grade I and II urinary stress incontinence occurs in about 12% of patients. Subsequent TURP or bladder neck incision to treat subvesical obstruction is common, and is sometimes even performed at the time of HIFU. Post-operative impotence will occur in approximately 55-70% of patients."

This above statement simply isn't true here in the USA. Maybe this European study had these results because they didn't use the Detrol, Flomax or Cialis that doctors who fly out of the country use to prevent these occurances. Plus all the other precautions that I was given, and easily followed.

I posted a study from the UK July 2009 where 1 man in 172 had urinery incontinence. You guys seem prejudice against that study.

I haven't used the generic Cialis, but many men have on other forums. I only offer up this info as info. we are all adults

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

What I posted was from a consensus document on Prostate Cancer from the European Association of Urology. It's based on combining data from 150 articles in the literature on HIFU. It's certainly possible that individual, more skilled HIFU practitioners might have a lower complication rate that summarized in these treatment guidelines.

The other issue they raise is that the followup studies are not yet adequate for them to regard HIFU as anything but an experimental treatment.
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John

notme · Guest

The NYU Langone Medical Center has started a FREE HIFU clinical trial.

It's being lead by my doctor, Dr. Scionti, so I have great expectations for this trial. They are using the Sonablate (best).

Dr. Scionti's advice & training will be invaluable.

Dr. Scionti has been treating men for 5-6 years. He is devoted, thoughtful, inventive and his follow-up is incredible, they send me questioneers every 3 months now.

find info here: http://urology.med.nyu.edu/conditions-we-treat/prostate-cancer/treatment/hifu

notme · Guest

.........OH RATS!!!

That clinical trial is only for failed radiation.....someday they will wonder why they even started with radiation.....

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