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Where Did HIFU Treatment For Prostate Cancer Come From and Where Is It Going?

Alex González from Sonacare Medical, leading developers of HIFU systems for prostate cancer, explains the origins of HIFU technology and how it has developed to become a powerful non-invasive treatment for prostate cancer.

Press play in the audio player below to hear the interview.

Please find below a written transcript of the interview.

Clare Delmar:
Hello and welcome to On Focus brought to you by The Focal Therapy Clinic, where we connect you with issues facing men diagnosed with prostate cancer that are little known, less understood and almost never talked about. Prostate cancer is now the most commonly diagnosed cancer in the UK, and with this somber fact comes a multitude of challenges and opportunities. I’m Clare Delmar. Joining me today is Alex Gonzales, global director of sales and operations for Sonarcare Medical, based in Charlotte, North Carolina. Sonarcare is a leading developer of high intensity focused ultrasound – HIFU – technology that’s used in the management of prostate cancer. Alex and Sonarcare have been closely involved with several clinical trials that have demonstrated the effectiveness of HIFU in treating men with early stage prostate cancer. And we’re going to discuss how this technology developed, where it’s going and what this means for patients. Alex, thanks so much for joining me.

Alex Gonzales:
Happy to be joining you today. Thank you.

Clare Delmar:
Let’s get right to this. It’s a very exciting area. And I think this is the first conversation I’m having with a technologist. And to really put some meat on the on the framework of what is HIFU and what does this mean for patients? I think a lot of patients have a lot of questions about this, and you are probably just the person to address them. So thanks once again for joining me. I’m going to start off our conversation, if I may, by just picking up on the point that Sonarcare was one of the earliest adopters of HIFU technology, I believe. Is that correct?

Alex Gonzales:
That’s correct. We were one of the original really commercialisers of the technology.

Clare Delmar:
Yeah, commercialisation. That’s probably a matter of putting it. So can you tell us how and where HIFU technology developed and then how Sonarcare was established around that?

Alex Gonzales:
It’s a wonderful sequence of events and people think that the concept of ultrasound with focalisation, with image guidance is something new. But in all reality, this started in as far back as 1972 with Professor Frank Fry and Professor Narendra Sanghvi in Indianapolis, Indiana, who had taken this concept of using ultrasound imaging, ultrasound guidance, focusing in ultrasound to treat glioblastomas – cancer in the brain. That of course developed and later spun out of Indiana University in the early nineties with the concept of why don’t we image, why don’t we focus this beam of ultrasound energy and why don’t we treat only a very discrete, precise amount of tissue, very similar to how you would focus in the sun’s energy with a magnifying glass, they found a way to do that with ultrasound. So now we’re able to see the target that we want to see with ultrasound, something noninvasive, something not harmful. And we’re able to treat using that same energy source, just hyperfocus over an area of pinpoint energy.

Clare Delmar:
That’s a really interesting way of describing it, because I think most people are familiar with ultrasound from a purely imaging perspective. And certainly every woman who has a child will have experienced ultrasound in utero, as you well know. So it’s a pretty familiar technology for imaging, but I don’t think anybody normally imagines that you can focus it and I’m using your word in the way that you’ve just described to actually effectively kill bad cells. Is that what you’re actually saying?

Alex Gonzales:
To very discreetly destroy tissue while simultaneously imaging the tissue? And it’s interesting, you mention women’s cancer, alluded to breast cancer. What HIFU did is it brought us up to par as to where women’s cancer had been. Women’s cancer, the concept of let’s find the disease by investigating it, let’s image it, let’s include imaging in the diagnostics.

Clare Delmar:
So are you referring specifically to mammography here?

Alex Gonzales:
Mammography, later on mammography and incorporation of MRI and CT, but the new concept in general of being able to use image guidance, let’s use that to also target the biopsy and then let’s use that to have a non-toxic, minimally invasive quality of life sparing technology. For us that was HIFU. That initial group that founded what was US HIFU 15 years ago, which is what led us to partnering up with Professor Narendra Sanghvi, remember that pioneer from the early 70s that was trying to find a way to use this to treat brain cancer. We partnered up with his spinout that came out of Indiana University in the early nineties called Focus Surgery and US HIFU was born US HIFU now being Sonarcare Medical. We’ve rebranded along the way, as we’ve entered many, many markets and received approval to use this technology commercially in over 30 countries since.

Clare Delmar:
OK, all right. So is it true that Sonarcare, as you now are, uses HIFU exclusively for prostate cancer?

Alex Gonzales:
We use it exclusively for prostate tissue ablation is our formal approval by the FDA here in the United States. In other countries, we have approval for specific disease states. In some countries, it’s even use for the benign prosthetic hyperplasia, that benign overgrowth of the prostate that leads a man to get up and have to urinate quite frequently and with significant urgency. So our approvals will vary depending on the market.

Clare Delmar:
But in the U.K. and the rest of Europe, it’s for treatment of cancer.

Alex Gonzales:
In the U.K. specifically, it’s used exclusively for the treatment of prostate cancer.

Clare Delmar:
Yes, OK, so that the regulatory environment has a big call on on how HIFU is actually being used. And I guess that’s beyond not just prostate, but in the other areas, because it’s true to say that you’re using HIFU for other organs or other tissue masses, not just the prostate?

Alex Gonzales:
There are other companies that use HIFU to treat everything from uterine fibroids, liver tumours, some experimenting even in pancreatic cancer, rectal cancer. So, yes, yes, the ability to focus that ultrasound beam over a precision, a pinpoint area is being explored in multiple tissue states. Yes.

Clare Delmar:
That’s a really good way of describing it. So just to focus it on the on the prostate cancer, but again, to look at HIFU amongst a range of focal therapies. How does HIFU perform in comparison with other forms of focal therapy? And here I’m referring specifically to prostate cancer.

Alex Gonzales:
When you look at any technology or any procedure, surgical or non surgical procedure, you want to look at a couple of things. Number one, does it control cancer? But number two, what does it do with respect to side effects and how do those side effects affect the patient’s quality of life, the patient’s family’s quality of life? Because this is important. We’re not just treating a disease state. We’re treating a human being as a whole. You can treat a man with prostate cancer, with radiation, with open surgery, with laparoscopic surgery, with robotic surgery, with freezing therapy and with high intensity focused ultrasound, with HIFU. What really differentiates itself is that it allows for cancer control while preserving quality of life because we’re able to incorporate precision guided biopsy into our planning, because we’ve got this millimetric precision and all this being done in a minimally invasive environment where there’s no cutting, no open surgery. We’re talking about a transrectal probe delivering this ultrasound energy not only to help us visualise, but also help us treat the tissue. So we’re talking about a minimally invasive, minimally toxic form of energy. You just reminded everyone that the the same type of ultrasound is what’s used to view babies in utero, to view a kidney, to view a prostate before it’s biopsied. So we’re taking this non-ionising, meaning no radiation involved, form of energy. We’re able to focus it over a very pinpoint area of precision, thus achieving the same level, very comparable level of cancer control, but while maintaining quality of life with the least amount of side effects. All prostate cancer treatments have a certain degree of incontinence, the man’s inability to control their urine flow. They all have a certain degree of sexual dysfunction associated with them. The veins, the arteries, the nerves run really close to the prostate, almost like like the veins on an onion, on that skin. So it has to be very discreet, very precise. And any form of energy or any teasing with a scalpel or any dosing with radiation makes those nerves very susceptible to damage. So although HIFU does have side effects associated with it, they are the same type of side effects as with the conventional, quote unquote, gold standard therapies. You will find that it has less degree, less percentage of a chance of impotence and incontinence while still maintaining good cancer control.

Clare Delmar:
And the product you use is called Sonarcare, is that correct?

Alex Gonzales:
The product we use is called the Sonablate.

Clare Delmar:
OK

Alex Gonzales:
Third generation of the Sonablate, that’s a device that’s manufactured here in the United States.

Clare Delmar:
And so everything you’ve just said about proving its efficacy in terms of both cancer control and reduction of side effects, that’s all come through over a series of clinical trials to prove this, correct?

Alex Gonzales:
That’s come through over a series of clinical trials, as well as over 45000 patients that have been treated with transrectal, HIFU prostate tissue ablation in over 33 different countries and with currently well over 80 peer reviewed publications showing its safety and efficacy. Yes.

Clare Delmar:
Well, that’s that’s quite a mouthful. I mean, you’ve just said, what, 80 peer reviewed? 33 countries. So tell us a little bit about these trials, because ultimately that’s the evidence base that’s going to convince any sceptics and invite anybody who’s already ready to go.

Alex Gonzales:
Sure. There have been a variety of trials, trials in which they try to randomise subjects into two groups, one that would get HIFU one that would get surgery. There have been trials that are single arm comparative, meaning you’re comparing someone that has failed radiation therapy and is receiving HIFU as a as a secondary treatment, as a salvage treatment. You’ve got trials to where you’re performing HIFU as a whole gland treatment, meaning we’re treating the entire thing regardless of where we found the disease. There have been trials where we’re only treating the side that is affected and further yet, there’s trials to where they’ve treated only where the significant portion, the significant disease has been found. So you’ve gone the gamut of the trials in the European community as well as the Asian community and here in the United States. What we received clearance for here in the United States in October of 2015 was a prostate tissue ablation indication, I like to think of it or explain it as it’s an acoustic knife. It is a tool that the physician can use for whatever tissue the physician would like to use it for, is my layman’s interpretation of that clearance.

Clare Delmar:
And back to the trials, it’s striking to me that the UK has been a world leader in adopting and implementing HIFU for prostate cancer patients? But why do you think this is?

Alex Gonzales:
The United Kingdom has been at the tip of the spear and has pushed the envelope with respect to men’s health, specifically prostate cancer diagnosis and prostate cancer treatment for many, many years. You can look up the history, the long, very positive history of Professor Mark Emberton, Professor Caroline Moore, Professor Ahmed, Richard Henley, Tim Dudderidge. These individuals have not been afraid to push the envelope and explore how to better serve their patients in the UK. And because of the dedication of institutions like University College Hospital and Imperial College and so many amazing institutions that you have access to in the United Kingdom, they’ve explored and compelled the use of better imaging in order to better diagnose, in order to more accurately treat. They have pioneered not only the way we treat, but they have changed the entire paradigm all together.

Clare Delmar:
Let me ask you a question, because when you said HIFU as a technology mode really, was introduced back in Indianapolis. You said that in the early 70s. That was before the advent of this precise imaging and particularly the new sequencing through multi parametric. So how did HIFU work then?

Alex Gonzales:
Back in the 70s, this is what led to this huge hurdle, because as it was being developed for glioblastoma, they literally had to remove parts of the patient’s skull and the computer to drive the ultrasound imaging and to create the amount of high intensity focused ultrasound energy literally took up an entire room. And there’s a picture of Professor Frank Fry in this room with his first HIFU device. And the entire room is just filled with computers. We didn’t have the computing power. We didn’t have the imaging technology to be able to consistently target that. Fast forward into the 90s with the development of technology, the progression of computing power, the incorporation of CT and MRI in the early 90s, and the proximity of the prostate to a mucosal opening – the prostate as it sits right on the other side of the rectum, it was easy to get to. Do don’t need to cut through any bone. There was no need to cut through any tissue. And transrectal ultrasound was already being used to visualize the prostate. So it almost lent itself to the to the modality it was about.

Clare Delmar:
Oh, that’s interesting. So just because of what you said, the access and the fact that you already had this as a way of seeing where the cancer was, it was ready made for this. But then the MRI has just given you that level of precision that has made this a far more powerful and effective treatment option, correct?

Alex Gonzales:
Correct. Correct. In the past, they had to put in that transrectal ultrasound, introduce that into the rectum. They kind of blindly took six or 12 samples of the prostate. They might find cancer. They might not. On average, there was a statistic a few years back that indicated that a man would have to undergo that moderate level of discomfort, having six, twelve, twenty four needles through his rectum on at least two different occasions before they actually found any cancer. That’s the downside of a randomised biopsy. Now, fast forward and picture where we are today. You can go in, you can have that canary in the coal mine. That’s what I always tell people, that prostate specific antigen or PSA is it’s not an indicator of whether you have cancer. It’s an indicator that your prostate is sick somehow and you need to do some investigation. So you have a simple five minute painless blood test, the PSA – canary in the coal mine – that says let’s investigate this further. Investigation further no longer means I’ve got to subject myself to this session and introduction of multiple needles in through my rectum, through the prostate, and wait for those results to come back just so that they can give us some potentially nebulous news of, well, we didn’t find anything, let’s check you out for another six months and then come back. Now we’ve got the ability to send someone for a basic MRI, this sequence that’s going to give us these images of abnormal looking, abnormal looking tissue that now have a strong correlation to the disease state of the prostate, still not a one hundred percent confirmation, but we’ve got very strong indications that a good MRI, read will, tell you what areas of high suspicion you should investigate further. Take that one step further with technology that we now have that can precisely guide the physicians needle into those areas, we can still do randomized biopsies on the prostate, but now we’ve actually got some targets we can see in real time. Put a needle right through that. And once we get confirmation on the patient’s disease state, you can transfer that MRI data to the Sonablate HIFU platform and use it as a map. We call that our MRI image fusion technology. So now we have a map to the targets to be used on the Sonablate HIFU device that can precisely lay a deposit of energy on those targets. It’s like something you’d see – if there’s any sci fi fans – in a Star Trek episode. You kind of have this this wand or this probe. You see the tissue on the screen and you hit a couple of clicks on the screen and then you don’t.

Clare Delmar:
That’s a really good way of putting it. So, Alex, how do you see the future then for Sonablate and HIFU technology? Where do you think this is going?

Alex Gonzales:
I think what we’re seeing is this revolution where patients every year become more and more aware. Patients every year take more responsibility for their care. They’re doing a lot of research and we all joke that my wife says that I’m a WebMD kind of person, right. I look and I think I’ve got every every symptom, although there are some patients that do that. Most of the patients that I’ve come in contact with, there’s thousands and thousands over the past 15 years since I helped found Sonarcare, are very well educated, very well researched patients. They come in with binders full of information, and they just need help sorting it out. HIFU is not for everyone. There is a specific candidate and HIFU’s not here to necessarily replace insert you other technology name here. But HIFU is here to be a complement to a physician’s tool box. You’re looking at a future in which technology will play more and more of a role in diagnosis. Our ability to diagnose will come earlier in that patient’s disease state. We will be able to recommend less toxic, less invasive, more discreet treatments for these patients. And we’ll end up with these patients that were diagnosed early, treated with minimal harm and have allowed them to be productive, happy citizens for the rest of their lives. And guess what? In the event that the cancer returnes, you can treat it again with another HIFU.

Clare Delmar:
Well, that’s something I hope we can all look forward to. Alex, thank you so much for joining me. I really look forward to hearing more from you and from Sonarcare Medical about developments with HIFU. If you’d like to learn more about HIFU technology and Sonarcare medical, please visit for sonacaremedical.com . For a transcript of this interview and to learn more about how technology is improving diagnostics and treatment for prostate cancer, visit The Focal Therapy Clinic at www.thefocaltherapyclinic.co.uk . Thanks for listening and from me, Clare Delmar, see you next time.

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“HIFU is something people need to be aware of – I believe this treatment should be more widely available and more widely promoted. It wasn’t something suggested to me as a possibility by my urologist and I actually raised it myself. I would recommend HIFU and in fact have recommended it to others.”

Keith (The Focal Therapy Clinic Patient)

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