CBC take on HIFU....

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

Any new medical device introduced into the US for care of patients requires licensing by the FDA to demonstrate its safety and effectiveness. I think if the device is low risk, this is straightforward, but if it involves some active intervention (like frying tissue inside your body) more rigorous information is required. I don't think that HIFU is being treated differently than any other new medical device.

The link you give is a press release from a company that manufactures the HIFU device. I tried to find out about the Association of Italian Urologists by Googling it, and all I could find was links to this press release. The main urology society in Italy seems to be the Italian Association of Urology.
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John

channelsurferdude · Regular Joined: 21 Jun 2009 Posts: 12

Thanks John,

I thought they were doing trials on the treatment of prostate cancer, not the machine itself. I thought someone had said that other new modalities such as cryo, PBT and even the daVinci did not have to go through clinical trials.

This is why need to do our research and not rely upon hearsay evidence. even then, it is at times to distinguish fact from hype, information from knowledge.

notme · Guest

I only know for sure that no form of radiation had to go through clinical trials, and all forms of radiation has side effects--some don't come for up to 10 years. That's what my urologist told me anywho.

channelsurferdude....How did you know that I own a Toyota?? F-J Cruiser. Bad mileage....but great car!

Replicant · Moderator Joined: 01 Nov 2006 Posts: 744

It's not the technology that the FDA regulates.
The FDA regulates devices for safety and effectiveness.

In the U.S., the trial is for a device, not HIFU technology. The device is the Sonablate 500. HIFU does not require approval, never has, never will, because it is a technology, not a device. HIFU is already in widespread use in the U.S., but the device to use it on prostate cancer must be trialed.

When a radiation device is introduced that is simply an improvement over the older one--shapes the beams better, or what have you--the device can be approved under the FDA 510(k) process, and trials are not required.

Entirely new devices for U.S. use, like the Sonablate, need trials for approval. But once the device is approved, improved versions will be able to enter the market after approval without further trials.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm

Did you know HIFU is already being used in the U.S. outside of the trial? It's true. And new devices are getting approval all the time. For example, in 2006 Misonix got approval for the Sonatherm 600, a treatment for removing lesions.

HIFU is used laparascopically for kidney cancer. In the U.S.

Just not yet for prostate cancer. If it proves safe and effective in the trials, it will be.
_________________
Replicant

Dx Feb 2006, PSA 9 @age 43
RRP Apr 2006 - Gleason 3+4, T2c, NXMX, pos margins
PSA 5/06 <0.1, 8/06 0.2, 12/06 0.6, 1/07 0.7.
Salvage radiation (IMRT) total dose 70.2 Gy, Jan-Mar 2007@ age 44
PSA 6/07 0.1, 9/07 (and thereafter) <0.1
http://pcabefore50.blogspot.com

notme · Guest

Thanks for such a clear answer... so that means they already know that HIFU works on PCa.

Isn't HIFU also being used after radiation fails in the USA?

But, radiation never ever had to go through trials.

channelsurferdude · Regular Joined: 21 Jun 2009 Posts: 12

Ok...so if HIFU is being used, and I suppose they are using some device, why are both the albatherm and the sonablate going through clinical trials..and why does the FDA put restrictions on the size of the prostate for their trials.

Replicant, when you say they use HIFU fro kidney cancer, what type of device are they using?

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

It doesn't mean that they already know that HIFU works for prostate cancer, only that they don't license the technique itself. The FDA only licenses drugs and devices, not procedures. For example, no one approves a surgical procedure, although insurance plans or Medicare can decline to pay for a procedure if they think it is not indicated.

The FDA typically licenses a device for the treatment it was tested for. For example, the vagal nerve stimulator, a device used to treat epilepsy, was later also approved to treat depression a couple of years ago after the manufacturer submitted some clinical trials on depression.

Once the FDA approves something, it is on the market, and it can be used for reasons other than the orginal indication. A lot of medications are prescribed for "off label" uses, that is, a reason different than what the FDA approved it for originally. However, insurance companies sometimes refuse to pay for non-FDA approved uses.

Also, the FDA doesn't design clinical trials, the company that is sponsoring the study does. When the trial is done, the company submits the results to the FDA, and the FDA decides whether to approve it. The company tries to design the study in a way that they think will be successful when they submit it to the FDA.

Lots of treatments that are in common use don't have very good studies to prove that they work. For example, for a long time hormones were prescribed for women after menopause because it was thought that these were good for them, but eventually it was found that hormone replacement therapy had bad effects on health, including increased risks of breast cancer and heart disease.

FDA approval is a minimal standard to show that a device or a drug is safe and effective, but isn't proof that it's a good or the best treatment.
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John

channelsurferdude · Regular Joined: 21 Jun 2009 Posts: 12

Thanks John..but I still wonder what device is being use for HIFU treatment on kidneys...?

Marathon Man · Regular Joined: 17 Jan 2008 Posts: 49 Location: Ireland

I followed up channelsurferdude's Reuters reference and came up with this on the Italian Urologist's Association (AURO) site:

http://www.auro.it/wp-content/uploads/al10.pdf

Most of it is in Italian, but section 3b is in English and is of general interest, posting bullet point guidelines for a wide range of PC treatments, including HIFU. The PDF is 535 pages long, but the English section is fro page 59 to 82.

Under other therapies, there is an Italian section on HIFU fro page 374 to 376.

For what its worth, this is the section foreword translated using Babelfish:

They are essentially represented from the Crioterapia and the HIFU (High Intensity - Focused Ultrasounds) [1]. (LdP YOU). In phase of definition the classified role to the RITA (Radiofrequency Interstizial - Tumor Ablation) and to the Interstitial, methodical Microwaves considered in existence still experiences them, suffragate from studies of casuistry extremely limited [1]. (LdP YOU). The Crioterapia and the HIFU - they can be proposed, in patients selected, or in the primary treatment of the prostatico carcinoma clinical organ-confined or locally advanced, than with rescue purpose after radioterapico failure, offering certain advantages represented from the absent or insufficient meaningful ematiche losses, from the possibility of execution in peripheral anesthesia, with limited stay in hospital, and from the repeatability of the treatment in case of therapeutic failure [2]. (LdP YOU). To forehead of the above-mentioned advantages obvious limits, constituted from - the lack of studies exist still randomizzati clinicians, with appraisals analytics carried out exclusively on casuistry studies (n° max Crioterapia patients: 975, n° max patients HIFU: 599), and follow-up relatively breviums (Crioterapia: max 7 years, HIFU: max 5 years) [3,4,5,6].

MM
_________________
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

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

Replicant · Moderator Joined: 01 Nov 2006 Posts: 744

The Sonatherm 600 was approved by the FDA to treat kidney cancer, and other soft tissue lesions (but not prostate cancer) during surgery:

http://www.medicaldesignonline.com/article.mvc/Misonix-Receives-FDA-Approval-Of-Second-0001?VNETCOOKIE=NO
_________________
Replicant

Dx Feb 2006, PSA 9 @age 43
RRP Apr 2006 - Gleason 3+4, T2c, NXMX, pos margins
PSA 5/06 <0.1, 8/06 0.2, 12/06 0.6, 1/07 0.7.
Salvage radiation (IMRT) total dose 70.2 Gy, Jan-Mar 2007@ age 44
PSA 6/07 0.1, 9/07 (and thereafter) <0.1
http://pcabefore50.blogspot.com

notme · Guest

the restrictions on the size for the clinical trials is different for both machines:

For the Ablatherm: the machine is pre set in height of treatment zone and can only treat a gland up to 25cc. or 2.5 high. In Europe they do a TURP to reduce the size. The trials won't allow any TURPs or hormone reducing.

For the Sonablate: due to the limited focal length of HIFU, gland volume cannot be 40cc or larger.

This is from the independent charity for prostate cancer resarch:

For the majority of patients, the goal of HIFU therapy is curative. Therefore, in my opinion, any patient with organ-confined prostate cancer may be a primary candidate. As with cryosurgery, HIFU can treat the entire prostate capsule and beyond, so HIFU can also be used to treat prostate cancer that has begun to spread beyond the capsule. If capsular or neurovascular bundle invasion has been detected (by DRE, Endorectal MRI, ultrasound, or biopsy) these areas can be easily and safely treated with HIFU. More importantly, if there is no capsular invasion and the neurovascular bundles are not involved, the nerves can be spared, and potency maintained (depending upon the skill of the surgeon).

Seminal vesicle invasion is a problem for all therapies because there is a higher incidence of occult metastatic disease with seminal vesicle involvement. Early seminal vesicle invasion can be treated with HIFU. As developers continue to improve and develop the HIFU equipment, I anticipate further seminal vesicle therapy.

Thus, the best candidates for curative intent are clinical/pathological stages T1c-T3, with an understanding that the higher the volume/stage, the higher the risk of occult metastatic disease. As in cryosurgery, the Gleason score does not affect the lethality of HIFU.

Due to the limited focal length of HIFU, gland volume cannot be 40cc or larger. If the gland is larger, then downsizing is required with total androgen ablation using a gonadotropin-releasing hormone (GnRH) agonist, (e.g. Zoladex®) a non-steroidal antiandrogen (e.g. Eulexin® or Casodex®), and a 5-alpha reductase inhibiter (e.g. Proscar® or Avodart®). This same protocol has been utilized for preoperative downsizing for brachytherapy and cryosurgery.

Salvage Therapies
Aside from primary therapy, HIFU can be utilized as salvage therapy, primarily after radiation. With the Sonablate® unit, brachytherapy seeds do not interfere with the energy transfer. With the majority of radiation failure patients, the surrounding tissue is damaged, and the complications of incontinence, impotence, and rectal injury are increased in any form of salvage therapy (salvage radical prostatectomy or cryosurgery). Because of the excellent control and targeting of tissue afforded by HIFU, I personally feel that HIFU will emerge as the best choice for salvage therapy. To date, the reported incidence of incontinence and rectal injury is much less than for salvage radical prostatectomy or cryosurgery. If there is local recurrence after radical prostatectomy, and a lesion left behind can be visualized on ultrasound, then there is a chance that HIFU can be used to treat that lesion. HIFU can also be used for palliative therapy, debulking large symptomatic tumors that are causing pain, bleeding, and obstruction. As with cryosurgery, the effectiveness is limited by the gland size.

Also as with cryosurgery, HIFU can be repeated, without any increase in risk or complications. HIFU can also be used to treat cryosurgical failures, if there is no undue calcification present. Finally, if necessary, radical prostatectomy can be performed after HIFU.

http://www.prostate-cancer.org/education/novelthr/Chinn_TransrectalHIFU.html

Replicant · Moderator Joined: 01 Nov 2006 Posts: 744

Notme, this is the last time I will respond to this statement

"Radiation never had to go through trials."

Radiation is not a device.
Devices go through trials for FDA approval.
Therefore, radiation never had to go through trials.

So what is your point? Is your point that HIFU has to go through trials? I just pointed out that that is NOT true. HIFU is not a device. Therefore HIFU does not go through trials. New devices go through trials.

The first IMRT device approved in the U.S., the Peacock System, went through trials. Subsequent improved devices did not need trials. Just as once Sonablate is approved, subsequent improved devices will not need trials.
_________________
Replicant

Dx Feb 2006, PSA 9 @age 43
RRP Apr 2006 - Gleason 3+4, T2c, NXMX, pos margins
PSA 5/06 <0.1, 8/06 0.2, 12/06 0.6, 1/07 0.7.
Salvage radiation (IMRT) total dose 70.2 Gy, Jan-Mar 2007@ age 44
PSA 6/07 0.1, 9/07 (and thereafter) <0.1
http://pcabefore50.blogspot.com

Marathon Man · Regular Joined: 17 Jan 2008 Posts: 49 Location: Ireland

[quote="notme"]....HIFU can be repeated, without any increase in risk or complications.[/quote]

This is not supported by independent papers. I have come across quite a few dating between 2000 and 2005 that cite increadsed complications on repeat HIFU, however here are excerpts from three more recent papers:

1.
[b]European Urology
Volume 55, Issue 3, March 2009, Pages 640-649
Mid-term Results Demonstrate Salvage High-Intensity Focused Ultrasound (HIFU) as an Effective and Acceptably Morbid Salvage Treatment Option for Locally Radiorecurrent Prostate Cancer [/b]
Francois-Joseph Murat, Laura Poissonnier, Muriel Rabilloud, Aurélien Belot, Raymonde Bouvier, Olivier Rouviere, Jean-Yves Chapelon and Albert Gelet.

3.3. Side effects
The rate of urinary retention caused by sloughing and occurring within the first 3 mo after HIFU was 7.8% and required either a prolonged catheterization or exceptionally an endoscopic extraction of the necrotic debris. Urinary infections occurred in 3.5% of the cases and received adapted antibiotics. The specific post-radiation TP introduction in 2002 led to significant decreases in many long-term complications rates.

[Had to cut table a bit - didn't paste too well]
________________________________________
Patients 100 (167) 33.5 (56) 66.5 (111)

Long-term complications
Urinary incontinence 49.5 (83) 56 (31) 47 (52) 0.3
Grade 1 18 (30) 16 (9) 19 (21) 0.65
Grade 2 22 (37) 29 (16) 19 (21) 0.16
Grade 3 9.5 (16) 11 (6) 9 (10) 0.72
Artificial urinary sphincter implantation 11 (18 ) 20 (11) 6 (7) 0.009
Bladder outlet obstruction 20 (33) 30 (17) 14.5 (16) 0.01
Anal incontinence 1.2 (2) 4 (2) 0 (0) 0.11
Uretro-rectal fistula 3 (5) 9 (5) 0 (0) 0.004

Half of our patients presented with urinary incontinence, including 31.5% with grade 2 or grade 3 incontinence. The incidence of artificial urinary sphincter implantation was significantly reduced with the specific postradiation parameters when compared to standard parameters (20% vs 6%; p = 0.009). Similarly, bladder outlet obstruction (BOO) incidence dropped from 30% to 14.5% (p = 0.01). Stenosis was treated with cold-blade internal uretrotomy (24 patients), repeated dilations (5 patients), urethral stent (1 patient), self-catheterization (1 patient) and Bricker urinary diversion (1 patient).
Five patients developed a urethro-rectal fistula (URF) 2 weeks to 6 weeks after HIFU. All were treated with the standard TP before 2002 and underwent a double diversion: Bricker urinary diversion and colostomy. No URF was observed after the specific postradiation TP introduction (p = 0.0004).
Erectile function was not evaluated.
Complications after salvage HIFU are much higher than after primary HIFU.
Urinary incontinence is a significant concern, occurring at a rate of 49.5% in our series. However, only 11% of our patients required an artificial urinary sphincter implantation.

2.
[url]http://www.ukhifu.co.uk/pdfs/ConsensusofOpinionauthorchange.pdf[/url]

....the evidence base to support its [HIFU] use is relatively immature.

xii Within our group 3 recto-urethral fistulae have been reported in approximately 400 patients. Only one of these was in a primary treatment. As might be expected radiotherapy does increase the possibility of this complication

1.2. Urinary complications(4)

1.2.1. Following resolution of the immediate dysuria, incontinence rates are <2%.

1.2.2. Stricture rate is reported from as little as 1% but up to 25%. The experience of the group with respect to stricture rate is mixed and may well depend on catheter choice (urethral vs suprapubic).

1.2.3. Epidiymo-orchitis can occur in approximately 5% of cases.

1.2.4. Recto-urethral fistula is a serious complication but occurs in less than 1% of patients.

1.3. Erectile Dysfunction:

1.3.1. This is a difficult area to assess but impotence rates have been reported as low as 24%. But in general the consensus is that the erectile dysfunction in previously normal men is in the region of 40-50%.

1.4. Other complications:

1.4.1. Other expected complications are few. There is little discomfort, requiring only oral analgesia. Some men described perineal oedema, this resolves spontaneously and completely usually within 7 days.

3.
[b]American Journal of Roentgenology, AJR 2008; 190:191-199
High-Intensity Focused Ultrasound: Current Potential and Oncologic Applications[/b]
Complications from prostate HIFU are reported to occur with a frequency of 0–50% [118]. Reported complications include urinary retention, incontinence, urinary infection, impotence, chronic pain, rectal anal fistulas, and incomplete treatment of disease [118]. Repeat treatment with HIFU is associated with much higher complication rates than single treatments [118]. To mitigate urinary retention associated with prostate HIFU, some investigators perform transurethral resection before treatment [119, 120]; and in these patients, the length of time indwelling catheters remain in the bladder has been reduced from 40 to 7 days [121]. However, long-term follow-up in these patients is still not available, and because of the small numbers of patients who have undergone HIFU for prostate carcinoma, several authors have concluded that there are still not enough data to justify substitution of HIFU for more conventional therapies, although in short-term follow-up of up to 1 year, data look promising [122–125]. Prostate HIFU seems most appropriate in men older than 65 years, those who are not candidates for surgery, and those who are obese.

I've included the second reference because it comes from a HIFU practitioner group (as opposed to independent/peer/critic review) and outlines some complications with HIFU.

I've my treatment choice made, however if I get a relapse - God forbid! -, I may consider HIFU, however I'll be researching ALL options fully and taking papers, like the above, into consideration for all options.

notme, I'm not out to pick holes in your choice, but as a cancer mentor, I am concerned that the very many who cannot or do not research well, will take some of your statements, and those of the HIFU Industry, at face value and make, in their particular case, an inappropriate choice. HIFU is still regarded as an experimental method and, clearly, based on the foregoing, complications from repeat treatment are, in terms of incontinence and ED, at a minimum, at least as severe as any of the other treatments
_________________
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

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

notme · Guest

I don't like being the only guy with HIFU info, and I'm not a doctor nor do I know as much as you guys (for sure Replicant! I felt the slap! I just hope he never reads or responds to a post of mine again).

I sure wonder why NO one has said on any forum that they needed to be HIFUed again (that I've found). And yet when you look at the science behind HIFU it's clear that the Ablatherm is inferior as it is only capable of a small range. And, even the Sonablate, if a bit of cancer is missed then it will grow. The rate of incontinence in a second HIFU makes sense as the doc would have trouble working with so little tissue all squished into a shriveled gland. But, that's why I went with the most experienced doctor.

My one negative observation from other men who have HIFU is that the macho thing is alive and well. Many will not follow the rules, and this causes the complication of urethral stricture. And some doctors still give the foley catheter which seems to me is asking for a stricture. I also didn't feel that I needed to follow the rules, as it was going so well, and the procedure is such a breeze, but I did, and thus the perfect outcome.

What really bothers me about all this, is you all pick on HIFU, that it isn't perfect, while you don't measure it next to surgery or radiation. If measured next to them, HIFU stands head and shoulders above....especially with an experienced doctor.

My personal opinion is I would not have done surgery or radiation, I would have gone the hide and wait (AS) route. I much prefer quality of life to quanity, and a 50+% of incontinence and 35% recurrance is not something I will roll the dice with. As far as if I was in high risk, yes I would have still gone either the AS route or the HIFU route, as HIFU still has a 57% chance of success, I find those odds better than what surgery or radiation offer.

notme · Guest

[quote]Reported complications include urinary retention, incontinence, urinary infection, impotence, chronic pain, rectal anal fistulas, and incomplete treatment of disease [/quote]

I'd like to address these:
urinary retention: not taking Detrol as precaution to relax the bladder, not taking Flowmax to relax the spincter. Doctor used foley catheter, instead of supra pubic catheter.

incontinence: doctor hit a nerve or patient didn't clamp off catheter as recommended to keep his spincter muscle working. Should revive.

urinary infection: inadaquate care after, use of oil or gel to keep the catheter lubricated or doctor not clean. There will be a tiny drop of yellow goup at hole, this is normal, the body is trying to rid itself of a foreign object--could be confused with infection.

impotence: after the treatment the veins and nerves get shuffled around and need to find a new home, Cialis is recommended until all things settle in, as Cialis keeps the blood flowing and the veins open, this is expensive and I find many men don't think they'll need it, I took it for 3+- months 10mg

chronic pain: ???

rectal anal fistulas: the cooling system wasn't working on the machine, which is why internationalHIFU brings a certified mechanic to every treatment.

incomplete treatment of disease: a bit of cancer is left behind. But, remember ~ if cancer is outside the gland the doctor can see it and treat it as well (using the Sonablate), so this is an advantage over surgery.

The other rules men need to follow is:

drinking 48oz of water a day...keep the catheter with water running all the time, get those pieces of debris out of you, before the catheter is out.

Clamp off the catheter after 4 days for 2 hours a day--to keep the spincter muscle working, it's amazing how fast our muscles will slack off. do this everyday, increasing by an hour.

Keep the catheter hooked to the bag, so that the pieces can easily flow out of you through the catheter hole, not your penis.

Only wash with plain soap and water, never use any Neosporin or any thing else in the area.

No exertion, just a normal easy life for a month.

Take Detrol until the catheter is out.
Take Flomax for a month.
Take 10mg Cialis everyday for a month, then every other day for 2 months or as long as it takes.

You can buy Cialis (tadalafil) at AllDayChemist.com for $1. a pill.

I am not a doctor, just an interested experienced user.

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