Dr. Puneet Sindhwani - Prostate Cancer

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Transcript

Voiceover:
Welcome to Prescribed Listening from The University of Toledo Medical Center. Each week UTMC providers sharing insight into their medical specialty. This week, Dr. Puneet Sindhwani.

Dr. Puneet Sindhwani:
Hi, I'm Dr. Sindhwani. I am chairman department of urology and transplantation at The University of Toledo Medical Center. I'm also program director for the residency program for urology. I've been here going to be five years. So prostate cancer is the most common solid organ malignancy in men. So if you look at, in US, if you look at the lifetime risk, I think it's one in five men will get diagnosed with prostate cancer by the time they reach 80. So the prevalence is pretty high, by that time. And also prostate cancer is a slow growing cancer. So patients who have high-risk cancer in younger men are the ones that we are most concerned about. Many men who have slow growing, or what is called indolent cancer diagnosed later in their 70s may not die due to disease, but they typically die with the disease. So their lifespan may not be altered by that.

Dr. Puneet Sindhwani:
So high intensity focused ultrasound is ultrasound, which is at a high frequency. So instead of sound waves getting scattered, you try to focus it at one point. So like all other energy sources, if you remember as a child, we used to focus sunlight with the help of a lens to burn a hole in a leaf. So exactly in the same lines, you can focus the sound waves and in this case, ultrasound waves, to one point and that focus point close to that will generate so much heat there it can destroy the tissue. So the beauty of it is that the focus can be made variable depending on where you are targeting the tissue. So that's high intensity focused ultrasound in a nutshell. University of Toledo Medical Center is one of the very few centers in US, in an academic setting where we are doing HIFU.

Dr. Puneet Sindhwani:
We are the only center in Northwest Ohio where this technology is available. And we are proud to say that at UTMC the HIFU program has taken off very well. We have a team dedicated to just HIFU, starting with MAs, nurses, clinic managers, OR, that has been put to help patients who are opting for HIFU. It's a great treatment, a great step forward in minimally invasive surgical therapy for prostate cancer. And we know historically that in a prostate sample, it's only around 15% of the cancer tissue is scarred with cancer, the rest of it is non-cancerous tissue. So to treat just the cancerous area where significant cancer is and spare the normal tissue is the way to go. It has been shown in kidney cancer that instead of taking all the kidneys out, we are just taking part of the kidney out where cancer is. Same thing in breast cancer. Same thing in colon cancer.

Dr. Puneet Sindhwani:
Surgery has evolved in tissue sparing. And this was long due for prostate cancer to move that pathway so that we can do normal tissue sparing, seminal vesicles are spared and the sphincter's spared, bladder neck is spared and just treat where the cancer is. UTMC and the leadership has done a great job in bringing the technology here and our patients have been really, really pleased with the outcomes. They don't have to travel far to get this treatment, it's available right here in the neighborhood. High intensity focused ultrasound, which in an abbreviated form is called HIFU is typically if you trace back, it goes almost early 2000s. At that time, people experimented with destroying the tissue, especially in the deeper areas of the body, people tried it in the liver, it has been tried in kidneys. It has been tried in different solid organ tumors.

Dr. Puneet Sindhwani:
In 2006, the technology was conceived in Indiana, and it was excellent results with that in the animal models. So people were really excited. Unfortunately, the next development in the technology in the human field and the human trials happened all in Europe, not in US from there on because of some restrictions and also because physicians in Europe took the lead and took this in the area of the prostate. The advantage is prostate is a deep set organ. It's in deep in the pelvis. To reach it surgically it requires cutting through some vital tissue, which surrounds it, and to reach the prostate in the surrounding organs. So to have some energy source that you can aim at the prostate, which is diseased, was revolutionary idea. So in Europe, in UK especially, they started treating prostate cancer with this HIFU. What they were doing is they had this ultrasound unit that will do the imaging, meaning they'll take pictures of the prostate and focus on the area where biopsies were found to have positive cancer.

Dr. Puneet Sindhwani:
And they'll treat that area with this focused ultrasound. Initial results started piling up. They had very good results and it became a treatment which was offered widely over in Europe. Some of the US urologists noted those results and said, "Wow, why can't we do it here?" We couldn't do it here because there was no FDA approval. Why didn't we have FDA approval? Because FDA approval is granted based on the trials done within US. So unfortunately by then there was no trials that were done in US, all the data was Europe based. Well, there was some data from Canada also coming up, very encouraging data. So what US urologists started doing is taking their patients to either Canada or Caribbean or even Mexico and doing the procedures, HIFU procedures in these countries. And now they start gathering data based on US patients, but they were treated offshore.

Dr. Puneet Sindhwani:
So ultimately, two years ago, FDA gave the approval to the technology for ablation of the prostate tissue. They did not specifically say prostate cancer because they were not sure yet what the cancer outcomes are going to be. Many times FDA will approve a technology and then that technology can be used elsewhere. And same thing, it happens with certain medications also, right? So you can have medication that's approved for headaches and somebody takes it for backache or something similar to that. So that's called off-label use. So this technology was approved for ablation or killing of the prostate tissue and by default, where you want the prostate tissue killed is more so in cancerous tissue than the benign tissue. And that's why people started using it for prostate cancer.

Dr. Puneet Sindhwani:
This year in January, Medicare and CMS approved the procedure. So that was a big step forward. And based on that, the technology now has come into popular attention and more of the urologists in US are now adopting it. They still haven't come out and revised their guidelines, but it is at the various neurologic associations, Canadian Urology Association, European Urology Associations, they are making this as a part of a treatment option to be discussed with prostate cancer patient. The beauty of this procedure is, there is no incisions, no cutting involved, no blood loss like you have with general surgery. So on the day of the procedure, patient comes to the operating room, they will be under anesthesia so that they don't move during the procedure. The focused ultrasound beam is so precise that you don't want patient to be wiggling around because that focus would go off a little bit, right? So you have to make sure that the focus is where you exactly want it to be.

Dr. Puneet Sindhwani:
So that's why you need general anesthesia. After anesthesia is induced, we drain the bladder by putting a catheter in, this also helps us to define where the urethra tube is running through the prostate. After that we have a probe, which is introduced through the rectum and has an ultrasound on it. We obtain the images, line up this probe images that are obtained with the ultrasound, with the MRI images that we obtained before, that way we can see which areas the fusion biopsy was done, now where to treat that, where to focus that ultrasound beam. After that you do, the second part of the procedure is called fusion. So once you've done the fusion, then you do the mapping. In that mapping, you delineate an area where the biopsy was positive for cancer, and you leave a robust margin around it for any abnormal cancerous tissue that might be around the area of the biopsy.

Dr. Puneet Sindhwani:
And then once that's done, the computer takes over from there on and then computer starts to shoot ultrasound waves, very precisely in the area that you have demarcated. Once that's happening, your job is now very critical to make sure number one, focus is right where you want it. Number two, the surrounding tissues are not getting too hot. So you're supposed to monitor the temperature very closely, especially in the area of the sphincter, which controls urination, or the nerves which control erectile function. So you make sure that these areas are not getting to excessive heat where it's not required. Then you make sure that the rectal wall is not getting too hot and it's not getting destroyed. So once again, you have to keep an eye on all these parameters.

Dr. Puneet Sindhwani:
So typically for every 10 grams of prostate, it takes one hour to ablate the tissue. So a standard procedure may take two hours, two and a half hours combining all this. And once we are done, the rectal probe is removed and the catheter is attached to a drainage bag. Patient is woken up in recovery, as soon as they're able to take ice cubes or water and they're stable, they're allowed to go home. So the beauty of it once again is that their recovery is really quick because you have not done any massive shift in the fluid or they haven't had a blood transfusion. Most of the patients who do desk job can resume their desk job within 48 hours. If they are doing manual labor, then they have to wait at least five to seven days till their catheter comes out. And once the catheter is out they can resume their daily activities.

Dr. Puneet Sindhwani:
It's much easier as compared to surgical removal in terms of anesthesia. There's not much fluid shift. The patient is in a supine position, meaning they are just laying flat unlike robotic surgery even sometimes patients have to be tilted so much that their head is down and feet are way up in the air. That can cause a lot of fluid shift. It can interfere with their ventilation, lung function, heart function. So it's more stressful on the body, surgery. And most important in these days is the exposure. Since it's outpatient, it's a one time treatment, patient gets treatment and has gone home. So exposure to COVID is much reduced. And not only COVID now, other hospital acquired infections are minimized. In terms of patients who choose radiation, they have to come to hospital five days a week, typically, it's a four to five weeks course and sometime up to six weeks course of radiation. So they have much more disruption of their lifestyle.

Dr. Puneet Sindhwani:
They'll have more risk of exposure and so as compared to radiation, it's much more beneficial also. Since sound waves are a clean energy, meaning it does not cause secondary damage, as that happens with radiation, the urinary incontinence is almost zero in patients where it's a focused treatment done. If you look at overall series where they did Hemi-gland ablation, meaning they had half the gland ablated or three fourth of a gland ablated, the incontinence rate varies from three to 5%. And same thing with erections, excellent profile in maintaining erectile function. And various series that are published their data showed that the rates have been anywhere from five to 10% when done in a focused setting. So very favorable side effect profile, quick recovery and minimum disruption in patients lifestyle.

Dr. Puneet Sindhwani:
So, and the efficacy can be looked in three different things. One is we should look at efficacy of what is the cancer controlled, right? First of all. Number two, what is the efficacy in preventing the side effects? And most importantly, the lifespan, does it help patient to live longer or what is the cancer specific mortality, so to speak. So this is a little bit tricky to gauge all of these with the technology that's fairly new on a cancer that's rather slow growing, right? So prostate cancer, typically you want 10 year data or 15 year data on survival, which in case of HIFU, we do not have US data. The data that's published, the longest series has been from UK and they had their median five-year data that they reported. And in their data, the failure-free survival. So they define the survival failure-free, meaning that patient does not need a radical treatment like going to surgery or going to radiation because they failed the treatment. In their series, it was around 90%.

Dr. Puneet Sindhwani:
So excellent failure-free survival that they reported in terms of cancer treatment. Overall survival, meaning their patients they followed for long period and for cancer-free survival, meaning how many of them did not have metastatic cancer that killed them, so in those terms, the cancer specific mortality was almost zero or 1%. So it did not cause any patients in their series to lose their life to prostate cancer after this treatment. In cases where there's a high chance that cancer has already spread outside the prostate, meaning it's not localized, to offer that patient a Localized treatment will be a disfavor, right? So any patient who is a candidate for localized prostate cancer treatment will be a good candidate for HIFU. So what does that mean? That means patients who have intermediate risk disease, meaning Gleason seven, ideally, or lesser, PSA less than 20 and a prostate gland that's less than 45 grams or so.

Dr. Puneet Sindhwani:
So these are rule of the thumb kind of things that you screen by. There can be a little bit variation here and there, but as a rule of thumb, prostate is not too large, it's does not have too much calcium deposit in it, so make sure that patient can have ultrasound waves going through the prostate and not hitting the calcium. If PSA's too high by default, it kind of indicates that the cancer might be spread outside. And similarly, if it's a high grade cancer, Gleason eight, nine or 10, this patient may not be served by HIFU just to the prostate. Because once again, they have a higher chance that the cancer might be spread outside or it might be in the lymph nodes or the bones. Right now, there's a category of patients and who are on what is called active surveillance.

Dr. Puneet Sindhwani:
So these are the patients in whom we are kind of just watching the cancer parameters with the help of their PSA, doing frequent blood tests, by doing the PSA testing or we are checking their MRI and making sure no new areas of cancer are appearing and then treat when any of these indicators show that the cancer might be starting to spread. So in these patients who are in active surveillance, the anxiety levels are pretty high. And if you look at their long-term data, you put them on active surveillance, but almost one third of these patients, one in three patients come off of active surveillance within five years. So, and the reason for that is, it's just too much burden on patients, psychologically that they have cancer, they're following it closely, every time PSA test is drawn they're waiting for the test to come back, "Oh my God it's going to be high. [inaudible 00:18:42], is the cancer spreading? Should I get treatment?"

Dr. Puneet Sindhwani:
So given a treatment that has a such favorable profile like HIFU, now you don't put these patients through this uncertainty, you can just offer them HIFU. Now you're taking care of the area where the biopsy was positive. Now you follow their PSA and there's much lesser anxiety. There's much better chance that you have taken care of the cancer while it was in very initial stages. So that's one indication why somebody can offer HIFU. Other is, patients who are poor anesthesia risk. That yes, this patient has Gleason seven disease and should undergo surgery, but they are concerned about anesthesia risk. That's another indication to put them to HIFU. Patients who are on blood thinners. So HIFU can be offered to patients while they're on blood thinners. Next, patient who is really concerned about lifestyle issues.

Dr. Puneet Sindhwani:
For example, a young couple, they may want to maintain their sexual function. And patient may want a treatment where sexual function is maintained, where ejaculatory potential is maintained where they can have good active sexual lifestyle. In them, out of all these treatment options that are available, HIFU has the least incidence of causing erectile dysfunction. Another person might be very concerned about their urinary incontinence. So in those patients also, it's very beneficial to offer HIFU because their bladder control is excellent afterwards and their risk of having any urinary leakage is three to 5%. And that by any, in that study they discussed, even if patient had no requirement of pads, but still thought that they may lose any drop here or there, they labeled it as incontinent. So excellent side effect profile. Patients can maintain their lifestyle, quality of life is maintained, that might be an indication to recommend HIFU to somebody.

Dr. Puneet Sindhwani:
I think the things to look out for in future is going to be refinement in HIFU. As the technology is advancing, we are figuring out that the best way to biopsy a prostate is with a fusion biopsy, which is more accurate in localization. It has a higher sensitivity in picking up significant cancers. So combining that data with HIFU, you can go and zap just the area where the biopsy was positive, in that you don't have to do white margins. That will further improve the side effect profile. Number two, it's a treatment that can be repeated multiple times, unlike radiation where there is a lifetime dose limitation, with HIFU there's no energy limitation. So even if 10 years down the road a new focus appears and PSA is going up, you can go and zap that area. So this kind of very precise local treatment only in the area where precision biopsy was positive, you can probably repeat the HIFU.

Dr. Puneet Sindhwani:
I think that's going to be a big development. And with the new technology, with the demarcation of where the vital structures are and you're going to be able to spare them even better by visualizing them, that's where the next step for HIFU is going to be. To offer focal treatment for prostate cancer such as HIFU, you need to know exactly where cancer was found, right? And exactly where the high-risk areas are. And rather than doing a blind biopsy, UTMC for last almost four years now has been on the path of doing what is called precision or fusion biopsy. So since we developed that capability, that looking at the MRI, looking at the high-risk area and biopsying and confirming where exactly cancer is, has improved our capability of offering the focal treatment. And that's why I think at UTMC we're doing a more accurate biopsy combined with the fact that we know where cancer lives, you can go after just that area with HIFU, these two factors have given us good results.

Dr. Puneet Sindhwani:
So there has been a lot of press and a lot of awareness around this HIFU treatment and a lot of insurances we have seen in our region here in Ohio are starting to cover the procedure. Once Medicare started covering it, some of the private insurance providers are also now covering it, but still it's encouraged that patients talk to their insurance. And on the university side here at University of Toledo, we have a designated person who checks on the benefits and tells patients ahead of time if it is covered to extent it's covered, if it's not and what their co-pay might be. So UTMC provides full service prostate cancer treatment. In the Northwest Ohio region we have our cancer fellowship trained urologic oncologists who are also part of multi-disciplinary team. So if somebody doesn't qualify for HIFU, we have options like robotic prostatectomy. We offer them radiation treatment also. And in some patients, if they are candidates or if are radiation failures, even cryotherapy which mean freezing the prostate, is also available. We also offer brachytherapy, which is the seed implantation in conjunction with our radiation oncology colleague.

Voiceover:
Thank you for listening to Prescribed Listening from The University of Toledo Medical Center. To learn more about the provider you heard on today's show, visit UTMC.utoledo.edu. More Prescribed Listening next week from UTMC.