HIFU- cancer treatment or cancer risk -Update

I should add that I feel very lucky that my hospital told me my chance of needing follow-up treatment after prostatectomy was probably >50%. It meant I decided to skip that procedure and go for one more likely to cure me first time, and hence I didn't have to deal with any of the prosatectomy side effects.

Just to say, I think HIFU as a salvage treatment after brachytherapy and in-prostate recurrence does sound a sensible option if it is possible since although recurrence in the target area after radiotherapy isn't that common, it is more likely to be focal where the brachytherapy just missed a bit than an initial diagnosis is likely to be focal. That's certainly something I would look at in this case.

As I intimated previously and nobody disagreed, you should have been made aware of how HIFU could impact further treatment.

You question the statistics and site the small trial in Germany where only 29 men were treated before discontinuing HIFU, yet on their own omission they only administered one session whereas other studies take two procedures as the protocol for HIFU.comparison. Also, with only 29 men treated, one has to question how good/experienced they were in doing the procedure. The Professor who administered HIFU to me is on record as having done 800 and is said to have now done over 900 procedures, so technique has improved along with better identification of suitable men. Also, you can't consider the results of one small trial not using recognised protocol as definitive for HIFU worldwide. There are often differences in outcomes for various treatments.reported in different trials but I would have thought that the Chair of Focal Therapy would be in a good position to give a general view. You just can't compare washing machine failure rates with PCa treatments, particularly as much will depend on correct patient selection.

As regards UCLH collaborating with the manufacturers of Sonarblate, I think this is usual and to an extent necessary for progress. That way problems can be jointly considered and improvements made. All the expanding number of hospitals who use HIFU must be happy with results to continue to use it on an increasing scale. I stand to be corrected but it is my understanding that even Prostate Cancer UK among others sponsor Focal Treatment research at UCLH.

Again, I am very sorry this has worked out badly for you, particularly as you were not well enough informed and based your treatment decision on what you believe were unrealistic odds.

Hello Barry

As always I wish you and all men a speedy and sustainable recovery from cancer whichever treatment pathway they selected and thanks again for your detailed reply.

Just to correct, the Study by Bhat (2021) is a US Study not the German Study you refer to which is by Duwe (2023).

Im pleased professor CM who treated you at a London Hospital has the experience of c.900 HIFU operations.  The industrial scale of HIFU treatment at the hospital is not at all surprising to me.  Her boss, professor ME, the Director of Surgery at the unnamed hospital appears to have been engaged in promoting the performance of HIFU equipment on behalf of SonaCare, the manufacturer at International Conferences. I say 'promoting' because use of failure rates of the Sonablate 500 device backed up actual research would not be to 'promote' its use, but simply to give specialist advise from an expert in the field.  In this example in 2017, ME quotes the (as far as I can see) an unsubstantiated 15% failure claim for the device in exactly the same terms used by Hashim Ahmed in the 2014 Seminar Article;

https://www.youtube.com/watch?v=_rX8V6wzfhE&ab_channel=SonablateHIFU

Here again is Ahmeds' 2014 Seminar Article

https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.sciencedirect.com%2Fscience%2Farticle%2Fpii%2FS1078143914002178&data=05%7C01%7C%7C5564629939d4431df98a08dbbaab0c27%7C84df9e7fe9f640afb435aaaaaaaaaaaa%7C1%7C0%7C638309016024723199%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ipoiRWWLEjSuOrFP99IFlVmuJcyQp%2BkDD8CLlOUJ9js%3D&reserved=0

The issue I have is much much wider.  As we said,  Ahmed is Chair of Focal Therapy Uk, in charge of the HEAT Registry which is approved by NICE to record data on the success of the HIFU procedure in the UK. At the same time, he is being paid by "SonaCare Medical/Focused Surgery/Misonix Inc/UKHIFU (manufacturers and distributors of the Sonablate 500 HIFU device) for travel to conferences/meetings and for training surgeons in the use of the Sonablate 500 HIFU device" as well as many other private and public grant sources.  All well and good on the face of it.  As you correctly say, developing and refining cancer treatments should involve public and private interests and expertise working together in the best interests of patient care.  There is nothing wrong here except, I can find no research basis for the claimed 15% failure rate of primary HIFU Ahmed quotes.  In his 2014 he refers to "Current data from more than 3,000 men treated internationally.." as the data source of the assertion, yet the HEAT Registry was only launched on 11th April 2017 by SonaCare with an initial 1500 patients. So he didn't get his data from the HEAT Register.  It may have come from the US and probably from SonaCare themselves who I believe operate a fee-for-use and maintenance of the equipment (I may be wrong). So they would be collecting usage and failure data.  

Coming back to washing machines, if you wanted to sell many many more machines, making over-optimistic claims about their performance would attract millions more customers, boosting profit margins.  I have to say, I find the fact I was advised in exactly the same terms used by Ahmed in 2014,  repeated by professor ME in the above you tube clip in 2017, and written in a letter to my GP in 2021 troubling to say the least.

I don't have the relevant medical training or expertise in statistical analysis to interrogate research studies in any depth. I simply read the results of 9 Studies completed between 2017 and 2023. Here is my quick summary of reported failure rates of primary HIFU, partial ablation:

2017 Garcia et al (Uni Paris-Descartes, Memorial Cancer Centre NY, USE, CEMIC Uni Hosp. Beunas Arries, LapPaz Uni Hosp. Madrid  - Reported primary HIFU failure 28.1% at 6 yrs

2018 Guillaumier et al (UCLH, Imperial + UK Hospitals, Uni Med Centre, Utrecht, Netherlands) - Reported primary HIFU failure 37% at 5 yrs (noted in Editorial comments in 2019 Thompson et al-Table 3)

2019 Marconi et al (UCLH, Guys, Kings, Imperial) Reported primary HIFU failure 26% at 1 yr; 52% at 2yrs, 64% at 3 yrs.

2019 Thompson et al (UCLH with Barts, Q Mary, Uni Oxford) Reported primary HIFU failure 37.1% at 2.4 yrs

2019 Stabile et al (UCLH, Imperial, CharingX, San Raffaele Uni, Milan) Reported primary HIFU failure 15% at 2yr; 41% at 5yrs, 46% at 8 yrs.

2020 Thompson et al (UCLH) Reported primary HIFU failure estimated 35% -40% over 12yrs

2021 Bhat et al (Sunt Med Uni, NY, USA) Reported primary HIFU failure generally estimated 35% -42%

2022 Reddy et al (Imperial, UCLH, UK Hospitals, Utrecht, Netherlands, Cancer Centre in Luzern Switzerland) Reported primary HIFU failure 31% at 7 yrs

2023 Duwe et al (Johannes-Gutenberg Uni with Carl-Gustav-Carus Uni, Germany Reported primary HIFU failure 37.93% at 2 yrs

15% failure rate seems to be more of a sales pitch from this research. All this does not paint a happy picture given that 6,177 primary HIFU procedures were undertaken at the unnamed London Hospital referred to above (my FOI established this data).  

Q1/ Would you take odds of 15% failure with the option of a second HIFU to avoid radical treatment with associated morbidity when your also told the other option is to 'watch' Gleason 4 cancer and see if it grows?  I would and did. But I was not counselled of the collateral damage to nerves and pelvic floor muscles and associated problems this causes later in radical treatment; or given the option of a primary prostatectomy or radiotherapy at that stage- see Q2/

Q2/ Would you take odds of 35-42% failure when its also pointed out incontinence and recovery of erectile function are much worse due to HIFU-induced fibrosis of nerves and muscles if you then need to go onto radical treatment, and if your also given the option of a primary prostatectomy or radiotherapy instead of taking the HIFU gamble? I would not and would definitely have taken the primary prostatectomy route.

So you see the wider picture is, there are serious questions around the care offered by the NHS to prostate cancer patients at this hospital and perhaps other "Centres of Excellence in HIFU" which may mean up to, say 3000 to 5000 men may have taken a treatment pathway they would not otherwise have chosen due to lack of, and/or inaccurate counselling, disabling their informed consent.

We should also consider the many tens of millions of pounds of NHS budget spent on potentially abortive MRI and PET scans, biopsies, consultations and hospital stays; and the extension of cancer treatment for those men with the amplifying effect we know it has on stress for them and their families. That is why I feel strongly about this.

Edited by member 06 Jan 2024 at 12:53  | Reason: Not specified

Interesting ref to studies and I, as well as I am sure others, will be interested to see what response you receive. As a full time Carer for my wife who has advanced Dementia I don't have time to do much research now.

Normally, I don't set great store by what the press say about PCa treatment, often dramatizing what many already know, although the list of top Surgeons for Prostatectomy as recommended by Surgeons and listed in the Daily Mail is sometimes referred to on this forum as well as elsewhere; so you may be interested in this link as it includes reference to HIFU. Certainly, NICE have blown hot and cold over HIFU but another volte face appears to contradict their stance you posted in your early post. https://www.dailymail.co.uk/health/article-12284029/Prostate-cancer-care-revolution-UK-scientists-leading-way-raft-breakthroughs.htmlMore specifically, it says 'While advances in treatment can be slow — it takes time to carry out the research needed to prove they are effective — in March, the European Association of Urology changed its guidelines to support so-called 'focal' therapy'. This shift in position by the European Association of Urology is significant because it brings it in line with guidance from the UK National Institute for Health and Care Excellence (NICE), and should mean more men are offered it now it has the backing of a well-respected professional body, says Professor Ahmed.

'This change is going to have a major impact on the dissemination of focal therapy. It will lead to more centres taking it up and offering it to their patients.'

Until now it has been available only privately in the UK and in a small number of NHS hospitals — Imperial College Healthcare NHS Trust, University College London Hospital, Hampshire Hospitals, University Hospitals Southampton and Sunderland Royal Hospital, despite NICE recommending it.

Professor Ahmed's research shows focal therapy leads not only to a better quality of life for prostate cancer patients, but is also cheaper, making it a 'double win'.

'We think that around 30 to 40 per cent of men who have surgery or radiotherapy could have focal therapy but are not even told about it — that's an estimated 10,000 to 12,000 men a year,' he says.

'Now the guidelines have changed, physicians are going to have to tell them about focal therapy so that men can make an informed choice.'

The date of the article was originally 10th July 2023

Edited by member 09 Jan 2024 at 00:59  | Reason: to highlight link

Speaking of what they tell you, take a look at a website set up by a group of urologists under the chairmanship of [Doctors name removed by moderator]. The website is committed to promoting the use of HIFU, Focal.Therapy.UK https://www.focaltherapyuk.org/

Under 'About', on the site, it states 'overall recurrence (of cancer) is 5-10% at 5-7 years versus 5-10% for radical therapy'. Now compare that claim to the systematic research review I reported above concluding a cancer recurrence following HIFU in the range 35%-42%.  The discrepancy is due to the fact that the Professor doesn't specify how long after treatment for cancer recurrence was tested, it could be 5 minutes, and he doesn't say what recurrence means. It could be infield (in the treated area), or outfield, or cancer metastasised outside the prostate gland. The claim makes a nonsense of the statement on the site 'we are committed to high quality data collection'. They are not, only to the promotion of the procedure throughout UK hospitals based it appears from this, upon misleading statistics. With no mention at all on this website of the toxic effects of secondary treatments due to HIFU-induced fibrosis I have covered in earlier posts.

All the more concerning as [Doctors name removed by moderator] is the custodian of the HEAT Registry set up by SonaCare the leading manufacturer of the Sonablate 500 HIFU device to record data on the performance of focal treatment in the UK as approved by NICE. 

The Professor's own website states  '20% to 30% of patients over a 6 to 7 year period will require a second HIFU session to be applied to the same area that was treated at the beginning. The exact risk depends on the risk of the cancer at the time of the first treatment.'

https://londonprostate.co.uk/areas-of-interest/hifu-treatment-for-prostate-cancer/

Most men with cancer being non-medical, would take from this you have 20%-30% chance of failure of the primary treatment. And they would read you can always have a second treatment.  By containing his estimate of failure to 'within the area originally treated', the professor ignores outfield recurrence which will push failure rates back up to within the 35%-42% range as the studies Ive looked into above show. 

Turning to the title of my original post "HIFU Treatment or Cancer Risk";  in a 2019 Study (Marconi et al; Robot-assisted Radical Prostatectomy After Focal Therapy: Oncological, Functional Outcomes and Predictors of Recurrence) https://doi.org/10.1016/j.eururo.2019.03.007

the UK's leading prostate cancer researchers conclude: 

'Specifically, we identified that men experiencing an infield recurrence had almost  four times the risk of developing biochemical failure (suggesting cancer spread) after S-RALP (prostatectomy following failure of HIFU), independent of margin status, Gleason grade group, PSA, or pT stage.  This suggests that those experiencing infield recurrence might have a more aggressive cancer phenotype and are thus more likely to need multimodal (more than one type of) therapy with or without systemic (radiotherapy) therapy.  One hypothesis for this finding is that an initial incomplete ablation might result in the development of 'ablation-resistant' clones that repopulate the ablation field and metastasise locoregionally. The biological mechanism of this phenomenon is yet to be described and further research exploring the role of genetic and epigenetic alterations in these tumours is ongoing'

To my knowledge no such research has been published and the hypothesis remains unresolved to this day. Perhaps it is no coincidence that the two leading research centres in prostate cancer, UCL and Oxford University are 'HIFU Centres of Excellence' in partnership with medical equipment suppliers.

Are public private partnerships like 'HIFU Centres of Excellence' leading to improved research and better outcomes for cancer patients? Or are they leading to better outcomes for the manufacturers of medical equipment? The way clinicians like [Doctors name removed by moderator] promote misleading failure rates makes me doubt the former contention.

Edited by moderator 16 Feb 2024 at 18:50  | Reason: Not specified

Hi Paul,

I can fully understand your anger and frustration, because you believe, that you've been physically, mentally and financially damaged, by HIFU treatment. It seems some of your grievance is directed at misinformation regarding treatment and the contravention of NICE guidelines in relation to its use.

I can fully empathise with you. My circumstances don't involve HIFU, but they do echo your doubts on misinformation and the relevance of NICE guidelines.

I was given the wrong cancer staging, as was the first MDT meeting, when they recommended I was suitable for AS. I was therefore denied my right to make a fully informed treatment plan. Not only that, but by error, the 6 month follow up MRI, I was supposed to have, was not booked, and was delayed by a further 14 months. When they got the results the cancer and significantly progressed. This resulted in me having a robotic prostatectomy. 

During this 'care plan', in my opinion, there had been blatant breaches of care and NICE guidelines had been 'strayed' from on at least two occasions.

This all occurred in COVID restrictions. The communications between me and NHS consultants were woeful. It was not until a year after initial diagnosis, when I got copies of my full medical records, that I discovered these mistakes.  

I then began my "Quest for justice". Over the next year I formally complained to the Trust, three times and was fobbed off with incorrect, unclear, or contradictory replies. I then went to the PHSO, who informed me that they would request the Trust to try harder next time and reopen my complaint. They are, in their usual tortoise paced manner, reinvestigating my case. The whole complaints system is a complete joke.

I've even sought legal advise and was basically told, had the errors resulted in me having incurable cancer, I may have had a claim for clinical negligence, but as thing stood, because I'd just avoided this, there was no legal case to answer.

What I've learnt on my journey, is ensure that you keep full records of all treatment and consultations. The wheel does fall off, but no-one will ever admit not checking them. As for NICE guidelines, they are in a lot of cases, just that, guidelines, and legally not worth the paper they're written on. 

I've also learnt that the medical profession will quote NICE guidelines when it suits their case but pooh-pooh them, when they don't.

In addition to all of this, the nature of our disease, can result in so many different outcomes, making it impossible, to prove that you have been adversely effected by treatment errors.

I often see on here, people who have been badly let down in their care. I see blatant breaches of care, creating the likelihood of much worse outcomes. People should be made accountable for making these mistakes but they're not.

Edited by member 17 Feb 2024 at 12:39  | Reason: Spelling.

Hi Adrian

sorry to hear your story and the brick walls you have faced. Contrary to Lyns assumption I am not in the least angry. My profession involves deep research so Im happy to follow the bread crumbs and see where they lead, very much with the 700 or so other men who were sold a treatment which NICE rightly described as lacking efficacy and which, as I have revealed in research, can cause the growth of more aggressive cancers within the prostate. I take note the ancient Chinese writer Tzu Sun, when you act in revenge, first dig two graves. If I can get some compensation for my damaged health, assuming it is found I deserve it, all well and good. And Im in no hurry to collect the breadcrumbs, but collect them I will.

I do agree with you, just looking backwards at events, trusting and taking what some NHS consultants dish out is grossly unfair if they are at fault.

But important to focus on getting better first and not let those mistakes or misconduct mess up your life going forwards.

Edited by member 19 Feb 2024 at 11:08  | Reason: Not specified

I have had some criticism on here from members and even intervention from the Moderators.  All I have sought to do is to inform men facing prostate cancer of the truth about HIFU as a treatment.

To recap, a top consultant at a major London Cancer Hospital effectively promoted HIFU to me and my GP as follows (I quote verbatim):

"In terms of oncological success over a 5-10 year period, 85% of patients will just need one treatment, 10% of patients will need a second treatment and 5% of patients will need some other form of treatment; either in the form of surgery or radiotherapy, should the policy of tissue preservation fail to control the disease."

I have now have received under FOI a response from the same major London Cancer Centre to my request for data which discusses the ERUS presentation written by another a surgeon at the same hospital.  The ERUS presentation has been previously posted by me and others but here is the link again:

https://www.urotoday.com/conference-highlights/eau-robotic-urology-section/erus-2018/106785-erus-2018-a-pathological-landscape-of-recurrence-after-focal-hifu-forprostate-cancer-a-high-rate-of-adverse-findings-at-salvage-prostatectomy-and-limitedsensitivity-of-mri.html

So within the FOI response I received is the following statement:

"Results

Prior to HIFU, 55.9% had multifocal disease and 47.1% had Gleason 3+3 outside the treatment field. Median time to failure was 16 months (IQR 11-26). Indications for sRARP [salvage prostatectomy] were IFR [in-field recurrence] 55.8%, OFD [out-field detection] 20.6%, or both 23.5%.

On sRARP histopathology, significant cancer (ISUP>or=2) was present in 99.1% / 81.3% / 79.4% in-field, outfield and both respectively. 82.4% were adversely reclassified at " [text cut off]

Id be happy to supply copies of this FOI response to the Moderator if they're interested as the FOI is not as far as I can see online.  

When I discovered my cancer had reached the danger zone of Gleason 4 I was naturally psychologically vulnerable to 'a promise from heaven' like HIFU. But this research suggests HIFU is more like a game of whack-a-mole. You treat one lesion and another jumps into Gleason 4, either in or out-field or (as in my case) bilaterally.  Then upon HIFU failure ,without warning, I was told the NHS will not undertake a nerve-spare prostatectomy.  I was pushed towards radiotherapy or going private for an intra-operative nerve-spare prostatectomy to have any hope of saving erectile function.