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Focal Therapy – a view from across the Pond

An interview with Dr Art Rastinehad, Director for Prostate Cancer at the Northwell Health Cancer Institute in New York State, Vice Chair of Urology at Lenox Hill Hospital in New York City and Head of the Focal Therapy Society

Dr Art Rastinehad joins OnFocus to discuss how focal therapy is being implemented in the US, and how US and UK clinicians and researchers are collaborating to advance its development. Dr Art Rastinehead is Director for Prostate Cancer at the Northwell Health Cancer Institute in New York State and the Vice Chair of Urology at Lenox Hill Hospital in New York City. He trained at the National Cancer Institute as an Interventional Urologic Oncologist and is the first urologist to be dual fellowship trained in Urologic Oncology and Interventional Radiology. He has expertise in a wide array of interventional radiological and surgical techniques, including image-guided procedures, prostate artery embolization, laparoscopic and robotic surgery, and he has authored and implemented clinical trials of new techniques in the diagnosis and treatment of localized prostate cancer, including focal therapy.

Recent publication – consensus on moving to Focal therapy Active Surveillance https://pubmed.ncbi.nlm.nih.gov/33676851/

Dr Art Rastinehad’s website https://drrastinehad.com/

Clare Delmar

Hello and welcome to On Focus, brought to you by The Focal Therapy Clinic, where we engage you with issues facing men diagnosed with prostate cancer that are little known, less understood, often avoided, or even ignored. Prostate cancer is the most commonly diagnosed cancer amongst men in the UK, and with this sombre fact comes a multitude of challenges and opportunities. I’m Clare Delmar. As we move into 2022, I’m going to be diving deeper into some of the more challenging issues faced by both patients and clinicians, including advances in technology, clinical adoption of innovations, inequalities and non clinical aspects of prostate cancer. Joining me today is Dr. Art Rastenhead, director for prostate cancer at the Northwell Health Cancer Institute in New York State and the vice chair of urology at Lenox Hill Hospital in New York City. He’s also head of The Focal Therapy Society. He trained at the National Cancer Institute as an interventional urologic oncologist and is the first urologist to be dual fellowship trained in urologic oncology and interventional radiology. He has expertise in a wide array of interventional radiological and surgical techniques, including image guided procedures, prostate artery embolisation, laparoscopy, and robotic surgery. And he’s authored and implemented clinical trials of new techniques in the diagnosis and treatment of localised prostate cancer, including focal therapy. He’s here today to discuss how focal therapy is being implemented in the US and how US and UK clinicians and researchers are collaborating to advance its development. Art, thank you so much for joining me today. Rather large intro, but I’m really delighted to have you.

Art Rastinehad

Clare, I’m really excited to be here today. Thank you for that kind introduction, and I look forward to discussing the topics that we have laid out this morning.

Clare Delmar

Excellent. Well, then let’s just jump right in. Maybe you could start by telling me and telling our listeners about what drove you to introduce focal therapy in your practice and how has it been received?

Art Rastinehad

That’s a great question. I first started focal therapy and researching this in 2009 at the NIH with doctors Pinto, Wood and Choyke. We really felt that targeted biopsy was going to lead to a possible scenario that we could actually treat the areas that we biopsied with some type of energy or modality. So since I finished my fellowship in 2011, focal therapy has always been a part of what we’re doing. It has grown by leaps and bounds in the last decade. I initially first started with cryo in our practice, but we’ve expanded that to include nanomedicine, IRE, HIFU and modalities that hopefully are advancing. We focus on clinical trials. So in the long run, we’ve had focal therapy or some version of it since 2009.

Clare Delmar

Okay. So let’s talk a little bit about your practice – what and who is a typical patient that comes to you for focal therapy?

Art Rastinehad

We run an image guided biopsy program here at Northwell Health. We call it the RDP. We were collaborated with Hashim Ahmed from Imperial College develop a high throughput biopsy program so patients don’t have to wait from the time that their PSA is elevated to the diagnosis, if they even have prostate cancer. From that, those patients, some of them have one or two two lesions, are focal, their PSA is less than 15 or 20, and they have well visualised disease that we feel those patients would be optimal candidates for focal therapy. These patients can be enrolled in several of our trials that we typically do, or we are part of The Focal Therapy Society registry, where we track the outcomes of these patients with respect to cancer control as well as quality of life metrics. So that’s really where we gain our patients is from the shift to an image guided biopsy. Because what’s shocking, Clare, in the United States, prostate cancer was the last solid organ malignancy that wasn’t diagnosed with imaging until recently, 2019, when the AUA endorsed image first for all patients at risk of prostate cancer. So there’s been a tectonic shift, really 2009 marked that watershed moment for us.

Clare Delmar

Okay. That leads me into something I was going to ask you next, which is about what the actual pathway is from initial presentation to ultimate treatment. How did that shift and what does it look like now?

Art Rastinehad

When it began, most insurance companies in the United States did not cover MRIs for prostate imaging, but I would say mid 2015, 16, it really started to take off. A lot of private payers were paying, of course, Medicare in the United States, our national health care for older adults covered it all the time. So there’s a big shift then. By now, it’s commonplace. At our institution, Northwell Health, we no longer do transrectal biopsies. Everything must be transperineal, which decreases that infection rate, so the risk of a screen test is low. As well as every patient must have an MRI before a biopsy is done or attempted to obtain one. And that really has shifted it to really identify those patients at high risk. So that’s where we are today. So it takes about one week to get an MRI in our system. At the most. We have a collaboration with our radiology colleagues here to have a high throughput mechanism for that. And then within that next week, we have the patients see their primary care physician if they need to have a biopsy sedation or they’re booked to see the clinician to review the MRI, and then a biopsy is done. So we’re able to shrink that down to about two weeks, which is what we feel really exciting because typically this in the United States takes six to eight weeks, sometimes for patients to get through the whole situation just to get a biopsy to find out if they even have prostate cancer.

Clare Delmar

Okay. That’s interesting because I completely recognise that sort of paradigm shift, if you will, from the imaging and then how that leads to these much more accurate biopsies. What’s interesting, what you’re telling me is that a lot of these men going through your pathway will then have that very natural discussion of, well, yeah, focal therapy may be an option for you, is that correct? Because just to contrast it to often the patients that come to the The Focal Therapy Clinic in the UK is they’ve often already had a treatment recommendation, which is often what they don’t want to hear, i.e a radical procedure or a hormone treatment or sometimes even AS, which I want to talk to you about in a few minutes as well. So they’ve already had some bad news and they want to investigate their options. But I think what you’re telling me is your patients tend to go right down a pathway, whereas if they’re candidates, you present them with that option right away.

Art Rastinehad

Yes, we do. So it depends on which clinician they’ve seen of course. We have about 15 physicians doing targeted biopsy, and we have a pathway for them, and they move through that. We have the multi-D clinic and conferences to review their cases. But there’s an impact of the clinician preference, too. We haven’t standardised it that everyone’s forced to go into certain buckets for what they have. We present the opportunities. The challenge with focal therapy is that if a patient hears about it, then hears that you still can maintain your continence, you’re not going to leak after the procedure, you’re going to maintain your erections, and you’re a possible candidate. They don’t want to hear anything else about, you could have a radical prostatectomy or radiation therapy with hormones because they’re like, why would I do this? Because hopefully if we don’t burn a bridge, we still could have these other therapies. What’s the downside? I tell them that there is a downside. Right. We understand that there’s cancer control. I believe it’s a misnomer to claim that a prostatectomy is cancer cure because the biochemical recurrence rate is pretty much the same across the board. So regardless of the therapy they pick, they’re going to have to deal with a biochemical recurrence in some fashion in 30% to 40% of our patients. Right. Because that’s the biology of the disease. And what we’re trying to say is maybe we can decrease the incidence of metastatic disease and impact on your quality of life by this theory and process of focal therapy. And once they hear about it, it’s a real challenge. I have referrals from outside my institution. They ask that we don’t tell them directly about focal therapy. If the patients find out about it, it’s fine. But once someone hears that this is an opportunity, it’s really hard to change that direction because they don’t see a downside. They’re like, I understand there could be a recurrence, but I’m young and I do not want to go through the challenges of wearing diapers or having oral pills I need to get an erection or injections or even a prosthesis. So this is really that challenge and I think the team from Imperial did a study that showed there’s a treatment regret is around 40% of what decision people pick they’re unhappy with what they’ve chosen and wish they could have chosen differently the first time around. And you don’t really see that with focal therapy.

Clare Delmar

Yeah, that’s interesting. In fact, we’ve just done a blog about that. I completely understand that. So what are your thoughts on the future of focal therapy? Do you think this message is cutting through and not only the future of it, but also people’s access to it? Do you have any thoughts on that?

Art Rastinehad

I have lots of thoughts on that. As you mentioned in the bio that I’m one of the founding members of The Focal Therapy Society. We believe this is going somewhere. We have sponsorship from our parent organisation, Endo Society, and we’re pushing this forward. It’s exciting and I think it’s going to make up a large proportion of the market share in the future. 20% to 40% of the market for prostate cancer treatment will be focal therapy of some sort. As we get better imaging, better staging, we better identify patients for focal therapy, it’s only going to improve our outcomes. It’s not going to get worse from where we are today.

Clare Delmar

And it’s interesting because when you spoke earlier in the US context, which of course is quite different here. But one of the things I’m fascinated by, what these various different insurers or payers as you describe them, you’ve got two that are dedicated to older people. You mentioned Medicare, but there’s also the Veterans Administration, isn’t there, the VA? Which is, I guess it’s got a pretty large proportion of older people. Do you think they’ve had an impact on some of these innovations in prostate cancer treatments like focal therapy?

Art Rastinehad

One of my colleagues, Dr. George, works at a VA and provides focal therapy to those patients. So it’s all about getting the training. The NIH was dedicated to training physicians with these image based surgical skills, and that has really helped see the US with high quality individuals that can understand imaging and treatment. The other part of the question, when we look at this, the landscape in the US, I wanted to comment, a lot of times when we start, people are like, well, we need more data, then you get more data. And they’re like, well, it still should be on trial. This should be investigational. And some of the staunchest critics today currently are like, well, it should be the standard of care. There’s 6000 focal therapy cases done a year now in the US. Why are we even saying this should be done on a trial? Which is mind blowing to me because these are the same people that put up roadblocks initially with fusion biopsy. I still would have an old biopsy without imaging. I’m like, that doesn’t make sense. Then the focal therapy comes. They’re like, Well, I don’t think this should be done, it should be only on a trial only. Where’s your scientific integrity? And now, fast forward, 2022. We’re in a meeting a few months ago. They’re like, this should be the standard of care. I don’t know why people are still saying it’s investigational. My mind just exploded because we’re still doing stuff on registries. We’re still trying to get as much data as we can to support our position. But other people are like, well, this should be just completely integrated into the options for patients in the United States. I don’t disagree, but I still think that we should make an effort to track and follow people’s outcomes long term to make sure we’re making the right decision. That’s just good science.

Clare Delmar

Yes. And that’s also where some of the UK US collaboration I know has been happening. And I think it can happen even more now that we both have access to this data. We’re both creating this data. So that’s an exciting future.

Art Rastinehad

Oh, absolutely. I’m really excited. As we mentioned, we have the Focal Therapy Society has that sponsored registry, which we chatted earlier about those collaborations across the pond. I think the future is wide open as long as we approach this in a rigid scientific method. We’re going to really do great things for our patients. I worked with Dr. Emberton, Hashim Ahmed early on, 2009. I’ve been spending time with him, and Dr. Emberton really helped me change my career. He’s like, if you believe in this, I believe in this, you should focus on this. Stop looking at these other things. Dedicate your career towards focal therapy and imaging, because this is going to be the future. And I was the guy that already decided to do two fellowships, one in oncology one in interventional radiology so I’ve kind of run with it. And thanks to him, on the dark days when we’re challenged by either our colleagues and the negativity early on, I just kept forging forward and it’s really worked out for me and my career and a lot of other people have come along and joined the group.

Clare Delmar

That’s exciting. And also a lot of men and their families have benefited, most importantly of all. That’s incredibly encouraging to hear. Something I wanted to pick up on this area around collaboration and research. I noticed you very recently, that you co-authored a paper which aims to build a consensus, I mean, it happened to be sort of international, but a consensus on treating patients who are on active surveillance and moving them towards focal therapy. I’m just wondering if you can comment on what this means and how you actually see this impacting clinical practice and the growth of focal therapy.

Art Rastinehad

So every year or so, The Focal Therapy Society wants to address a few clinical questions and then use the key opinion leaders and the scientists from around the world to develop a consensus. Because right now, a consensus is the first step in developing a pathway forward. It’s not the last word, but it’s usually the first word. And by doing this, we wanted to look at the question of if you’re on active surveillance and you fail, what could be your next step? Because if you look at it, we’re going to have people progress from active surveillance depending on different clinical variables. And what should we do with those patients? It’s not an alternative to active surveillance, but if a patient has low risk disease that’s non-imageable, not been seen, it really puts them in a very low risk category. But if they have a new visible tumour and they have progression of their Gleason score, why not offer these patients focal therapy? We already found the cancer. We’ve identified it on imaging. This could be an area for further exploration. And I think we have developed a strong consensus that it should be offered, and that was the exciting thing about that and identifying which are the best patients for that.

Clare Delmar

Fascinating. I actually interviewed last year two men who were both started on active surveillance at exactly the same time, and one went on to have focal therapy, and the other one waited a bit longer and wasn’t able to do that. And their stories are really interesting. And I think I’ll refer our listeners, to those in the programme notes to this podcast. But I agree with you. It’s a very important consensus to achieve. So well done for that. I guess my final question – this has been amazing discussion – would be let’s focus to our listeners and to men who have recently been diagnosed with prostate cancer. What would be your advice to people who have been diagnosed with early to intermediate localised prostate cancer? Do you have anything you really want to say to them?

Art Rastinehad

I think first and foremost, remember that this is a slow growing, mostly non lethal disease when patients are diagnosed with low risk prostate cancer, pure Gleason six prostate cancer, we do not believe should really be called cancer. The word cancer scares patients.

Clare Delmar

Yeah.

Art Rastinehad

And in the past, oh, you had one core a little bit of cancer. Even if it’s Gleason six, those patients got radical therapy. So I don’t want to first say, I understand how you feel, you’re scared, but in the end, you won’t die of this disease. We’re trying to make this into a chronic condition that we live with that does not impact your quality of life because it is a disease of aging. And I think focal therapies play a major role in keeping men from suffering the side effects and unneeded radical therapies when they’re diagnosed. So that’s number one. Number two is if it wasn’t done with imaging, like using an MRI or some type of high quality imaging for the diagnosis, you need to get restaged and reassessed. We do not use ultrasound based only diagnostic techniques for patients with prostate cancer anymore. It’s really MRIs become the foundation. What’s exciting is PSMA may augment how we stage a patient after they’re diagnosed, which is great in the United States because anyone with an initial diagnosis of prostate cancer, we can get a PSMA, PET CT. It also says it’s for high grade. In the US, anything above six is high grade. There’s a little bit of a nomenclature issue there, but it’s covered. So we’re able to really stage patients better today and it’s only going to improve tomorrow. And then with targeted therapies, we’ve talked about intravascular agents. Since I’m an interventional radiologist, I do prostate embolisation for BPH, I have patients that have low risk prostate cancer. It’s non visible. With 150 gram prostate, we don’t want to really disrupt the anatomy sometimes so we can do an embolisation, the prostate shrinks, patient symptoms improve, and we continue to monitor that. There’s so much exciting things for you as a patient. We do not get nervous. We’re here to help and just make sure you find the right physicians to help you. And if imaging is not a part of their diagnostic strategy, I would look for a second opinion.

Clare Delmar

Okay. That’s really, really good advice. And I think we’re all on the same page, and I think you’ve definitely communicated how exciting this whole area is, and I hope we talk again in a few months time as things develop. So I want to thank you so much for joining me today. I know it’s very early for you in New York, and I appreciate that. And hopefully we’ll get a chance to speak again.

Art Rastinehad

Clare, it’s been my pleasure. I’m really happy to be here. Hopefully your listeners find us engaging. This is an area I think it’s going to really be a huge tectonic shift. Like to us, it’s been ten years in the making. We’ve been doing this for so long, but as you see mainstream people become aware of this, physicians now have been trained in these techniques and imaging in the United States, MRI quality has improved a lot, and as that improves, it only makes more patients available to be candidates for focal therapy. So it’s a pleasure to be here and discuss this stuff today.

Clare Delmar

Well, fantastic. Thanks again. A transcript of this interview and links to Art Rastinehad’s clinical practice and his research are available in the programme notes on our website, along with further information on diagnostics and treatment for prostate cancer and additional interviews and stories about living with prostate cancer, please visit www.thefocaltherapyclinic.co.uk. Follow us on Twitter and Facebook at the The Focal Therapy Clinic for listening and from me, Clare Delmar. See you next time.

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