This video features Andres Correa, MD presenting on Novel Transperineal Prostate Cancer Related Procedures. This presentation was given at our November 9th Optimizing Treatment Strategies for Localized and Advanced Prostate Cancer CME in 2022.
Good afternoon everybody. Thank you for the organization committee to invite me to speak today. My name is under Korea. One of the urologists, Fox Chase Cancer Center Today we're gonna speak about advances and transparent procedures for guo malignancies. So we're gonna start to talk. So I have no disclosures for this talk outline. We're gonna be talking about two advancements and transparent procedures. One of them is the transcranial prostate biopsy and the other one is the space or hydrogen for minimization of toxicity in patients achieving radiation therapy for prostate cancer. So we're gonna start with transcranial prostate biopsy. So again, we had a reckoning kind of in 2012 29 2012 when the SPF actually said that P. S. A. Was not actually a good screening test for patients for prostate cancer and the reasons they gave was twofold. One of them, they felt that the way that we were biopsies the cancer was causing too many complications to these patients. And to the fact that a lot of patients would be treated unnecessarily do you do to P. S. A. Screening? So urology has taken to kind of um two tracks in order to minimize these kind of situations that arise from P. S. A. Screening. One of them has been the use of active surveillance for patients with low risk prostate cancer. And so I think that that's been a significantly advancement in the management of prostate cancer patients. But the other one has been the fact that we've become a little bit more conversant about the complications especially infections complications associated rotations getting prostate biopsy. And so these have been a couple of snippets that have been kind of depressed. And also in our conference is about the fact that we're becoming more aware of what is the risk associated with transferred to prostate biopsies. So if you look at what are the transcript of prostate biopsies, complications, especially infectious complications, they are on the rise and these are two fold. One of them were doing more prostate biopsies than ever. And the reason for that is because now we're using active surveillance in patients with low risk and even patients with low volume intermediate risk disease. And that leads to the patient's having prostate biopsies in order to follow their cancer too is the fact that we are having increasing risk of but resistance associated with the continuous use of antibiotics. Many of those are the envelopes. So it's actually when you look at this graph and this study was done in the group in Canada is the fact that men with repeated prostate biopsies and the overall risk of infectious complications for the people undergoing prostate biopsy are rising and that's the concern as a result of this. The Eu a put on a group and they put out a white paper given recommendations about potentially what can be done to minimize this transport to infectious complications. And the two main topics that we discussed in the white paper are the use of trans rectal culture. So at the time about two weeks before the patient gets a prostate biopsy we swab director vote to make sure that the patient doesn't have any resistant bacteria in there. If they do, the patient should get a different antibiotics that they commonly utilized which is Cipro. There's issues about using Cyprus. It is we're gonna talk about those here but um definitely we should be moving away from using fluoroquinolones as the standard um antibiotic for the use of local axis. The other one is the one that we use the for a long period of time is just augmentation meaning using third generation cephalosporins um as a source of improved to decrease the risk of substance. And here we used to practice on the day of the biopsy for the patients undergoing across the biopsy. Something that was touched on but really not talked about in the paper was a transparent approach. And the reason for that is because they kind of said there was a procedure that was associated with increased with complications. So a little bit behind the curve. When it comes to our european colleagues which actually when you look at their guidelines transferring your prostate biopsy or is the first choice and if you have to do a transfer to prostate biopsy, they talk about using what we talked about um use augmentation prophylaxis or use target prophylaxis with a rectal swab. So again it looks like we're moving away from doing transfer to prostate biopsies and many because of the fact that that those infections complications are becoming more real. So is the field kind of moving away from the transcript of prostate biopsy. And the answer is is that there's still quite a bit of a debate. So these are two twitter polls that were put on by the prostate cancer and prostatic diseases journal. And it shows that again, if you ask neurologists what they'd rather have, I mean the great majority of them will stay transparent you but when they ask the questions that transcript a prostate biopsy still has a role in our field, they say that for the most part they do. So I think that um is something and there's reasons of why we're kind of to some degree um having this inherent friction about the adoption of the transparency across the biopsy. So when you look at what are the issues that people bring up about trying not to adopt the transferring your prostate biopsy. One of them is they think that translator complications are variant and they think that in their practice only one patient a year gets an infection. They don't feel they need to change the entire process is for one patient to the claim that there is an increased risk of your attention associated with the transportation technique and three the things that this need for general anesthesia or spinal anesthesia solicitation to be able to do this procedure. So in the next couple of slides I want to talk about and how to debunk a little bit of the smiths association associated with transcranial prostate biopsy. So let's talk about that. Tr biopsy complications, infection complications are rare event and the reality is it's not if you're looking at from a population level, Approximately 1-2 million biopsies happen every year in the US if you look at these rates and you actually multiplied by how many biopsies are done. We're expecting that about 60,000 patients will have an infection. About 20,000 patients will be hospitalized in the us associated with a transfer to prostate biopsy that is not inconsequential. Now, sometimes looking at these big numbers requires a little bit of context. So these are the two philadelphia stadiums. The Eagles are doing wonderfully this year. So imagine if you look at the entire Eagle stadium, about entire stadium full of men will get an infectious complication from a transect a prostate biopsy this year. And if you look at patients getting admitted because of the infection most likely because of sepsis is the same amount of men that will fit the hockey arena. So again, when we think about it in our silo silo practices, yes, it might be one a year. But we're looking from a population level. These numbers are really high and something that we really need to pay attention to When you look at transportation ooh prostate biopsy, the risk of infection are significantly decreased. So this is a mess to Systematic review of all the series that have published on transcranial prostate biopsy and you look, the risk of infection in that population is 0.076%. So it's extremely extremely low. So there's no question that transparent technique does decrease the risk of having a substance event. So where's the other one that we're gonna talk about? That one is increasing rescuing our attention. So when you look at a systematic review, looking at the complication rates associated with transferring you across the biopsy, When you look at the rates were significantly higher than the one that gets published for the trans rectal approach, the transcript approaches border between .2% and 2.6%. When you look at the numbers here in the column with the Red Square, you look at the rates are significantly higher. We're talking about rates between 6%, 7%, 8 And so even as high as 20% in some series. So it's not surprised that some urologists are a little bit nervous about adopting this technique. But you have to look at something when you're with these papers, it is the fact that when people were doing transparent prostate biopsies they were doing saturation biopsies. So you look at the main number of biopsies performing these patients is incredibly high. Like I think that at minimum people were doing 20 biopsies and that's comparing that to the standard 12 quote, that is done trans directly. So again, when you're doing 50, medium biopsies on these patients. No surprise you're gonna have urinary retention. So it's not an approach issue is the fact that when people were doing transcranial prostate biopsies that were doing it for saturation methods. And yes, if you put 20 biopsies 50 biopsies of the prostate, you're gonna have Some issues with our attention that's not associated with the procedure. What if we look at the largest series published today looking at transport your prostate biopsies from the group in Toronto, it looks like the risk of developing your attention is incredibly low is 1.6%. So it's very comfortable to the one transporter prostate biopsies and this is the patients that had an infection after the procedure was only .3% against significantly low and there was no septic events in hospitalization. So again is something to think about and something to realize that no transparent, your technique really does not lead to increased risk of getting our attention. And the last one is the need for general span honestly for these procedures. And the reason for that is because when we think about a transparent technique, we're thinking about about breaking therapy or saturation biopsies. And yes, nobody will do any of these procedures on an awake patient. But when you do a free hand transplant, your prostate biopsy, you're really not um doing that many biopsies and the procedure is really not more painful than having a transcript of prostate biopsy. So this is how we do it. This is here at Fox Chase. So this is how the passengers position. The first thing we do is we numb the skin very thoroughly with about 10 CCs of lidocaine. And then we use ultrasound guidance to numb the muscle elevator muscle and that that elevator muscles, the one that really hurts when you when you when you do the gaming. But once that is numb that might take 1 to 2 seconds. The patient really do doesn't feel the procedure whatsoever. And then we also do a pray for starting block right here to kind of blunt that sensation of people feeling they have to be every time you get a biopsy. So I tell my patients, is that going to the dentist? The nominee hurts. The procedure should not feel a thing after the nominee is complete. What is the data shows? So the data shows that when you look at pain scores throughout the entire procedure, mainly the pain scores are no different than having the pain associated with placing the transfer to ultrasound which is the same as you would think from trans rectal prostate biopsies. Uh in order on the left are the two techniques that we use to be able to do this biopsies. One called the middle axis system or the other one is the angio cath method. I'm going to talk about those a little bit later. So one of the two techniques that have been proposed. So the first technique is the one using this needle access system. Commercial is known as the precision point and what this does is that it fixes the needles so your needle is in line with the crystals. So what I'll ask you to do is to track the needle within the perineum a lot of it easier. So when you're starting these procedures it's nice things to have because at least it saves you some time from finding the needle in the perineum. So it does compared to the angio Cath technique is your needle tracking and shorter learning curve. Now the issue with the needle access system is that your your point is fixed within the skin and doesn't allow you to really have a lot of degree of freedom. So what happens here is that you might need a secondary access point either laterally for very big prostates or until early if you want to do interior sampling and that might be an extra stick to the patient that might cause some discomfort but also it just takes time. And also it's expensive. One of these devices cost about 200 bucks. The angio Cath techniques is just using 14 gauge and your cats that once you find an anesthesia and then you place them at two points in each side of the perineum to sample the right and the left, perspectively benefits is cost effective. Those annual cats is in cost sense. And also allows for greater needle mobility. So when you're moving your need on the perineum, you do not need a second access system. The other thing that is beneficial to this is that improves the way that you can do cognitive uh biopsies with this technique because you're able to go between sagittal and transverse and your ultrasound and allow that to actually improve. And I'll show you that in a minute the learning curve is a lot of it is a little bit steep because you have to learn where your needles coming and expect where it's gonna be. It's kind of like laparoscopy. It takes the time to figure out what your muscle memory is and where you have to be. And the other thing is tangential tracks because you're taking some more exaggerated angles to get to this area. You really need to be careful that when you're taking this angle is that if your needle is here is gonna shoot down here and your core samples that might be as robust, you might miss the prostate altogether. So something to think about when you're using this technique. So cognitive fusion. So I alluded to this in the previous slide. So what the group at what michael Jordan showed is that when you look at cognitive fusion biopsies using the transparent freehand technique. The hip scores. Pirates category are no different than back from true fusion and it makes sense. You know what I mean? Doing cognitive fusion during the trance rectal technique is quite difficult because your needle is shooting or dragon. So it's not shooting in the line. Whereas when you do a transparent technique actually your needles completely in mind. So this is a patient that has a pirate's five lesion here. Again, I need to hit that leash in. Um this is my needle here. I know I'm exactly what I need to be for that lesion. And I'll take a sample and our hit ribs here at Fox Chase right quite excellent and very comparable to those from the from the fusion side. So again if you haven't invested into a fusion software also if you have one and you think you might need to invest into the upgrade because of transition transfer. No that's actually not the case. So in conclusion, I mean the transcript of biopsy remains to try and improve an approach for diagnosis of prostate cancer. However it is associated with significant risk of infections, complications and two, we didn't talk about this. But the fact is that you can have trans rectal complications too. So you can have rectal bleeding and that's something that you don't have it all. A transparent technique. The transplant process reduces the risk of infection but about director contamination it can be done safely without the use of antibiotics and rectal bleeding as I said is completely avoided. The freedom method can be done safely and comfortably in the office setting under local anesthesia. I do at least two or three of those a week. Again, once you know the patient, the patient doesn't feel in the discomfort. The main thing is actually the position. That's what patients complain the most about. It has comparable or not improved protestant sampling because again, you can sample the interiors and a little bit better and has the ability to perform cognitive fusion, something that is very hard to do transfer actively. So moving to the second part of the stock which is advances to reduce electricity and the introduction of the space for hydrogen. So when you look at prostate cancer patients with localized prostate cancer, there was a very nice paper that was done with the group in Vanderbilt and looked at How many patients actually regret taking a specific treatment. So when you look at the three treatments that are available for localized prostate cancer surgery, radiation and an active surveillance, the overall rate of regret was 13%. The house was with surgery. The laws with active surveillance and 11% with radiation somewhere in the middle. And I think that this is deployed the best measure to see how we are. How good are we are giving our treatments and more importantly, counseling patients about how the treatment might affect the quality of life. So this is a nice paper that was done that looked at kind of institute and decision aid. So people were given a decision aid to kind of get things conceptualized about what is the risk of the cancer coming back? What are the risk of having a complication after his procedure to the patients? And while the trial showed that there was no impact between decision aid, institutional decision aid and regret. It did give us some Um factors that what is associated with decision regret. And the biggest factor was having bowel toxicity. So patients that experience bowel toxicity really regretted the treatment. So a big push from the radiation of colleges had been to reduce rectal toxicity. So what is director to 60 rates associated with modern um Hyper fractionated radiation of the prostate are not inconsequential. So their range between 14 to 17%, about 15% of patients gonna have some degree of greater than great, great to a greater toxicity associated with the radiation treatment. This is what rectal toxicity looks like indirect. Um this is radiation factories and you see these commemorations form some people can develop this alters like here in the white and those also can cause significant pain. And those deliberations can definitely lead to to rectal bleeding. So what are the two techniques that have been done to reduce rectal toxicity? So one of them is being the use of undirected balloons. So an undirected balloon. What it does is that it pushes most direct um out of the way. So it's not in the radiation field. So what you're doing is that by putting this balloon the lateral and posterior rectum, I pushed way out of the way in order to avoid direct toxicity. However, the anti rectum does get affected. The most novel way of doing this is using the hydrogen. So hydrogen have been used for a tremendous amount of applications, especially in orthopedic care, but also for implants in the plastic surgery. And now we're using them, especially the so called hydrogen for the criminal patients with prostate cancer. What is a direct appeal to do? So, as I said, this is here on the left is a patient without an indirect a balloon. And you can see that the majority of director is to some degree at risk of having some radiation toxicity because of the boundaries. Now, when you do an undirected balloon about, I'll say two thirds of the rectum doesn't get impacted anymore. However, you're putting the anti rectum at a higher increase those than you were before. And so to some degree, you're kind of robbing peter to pay paul when you do some undirected balloon and that's what this study shows. So more or less, an undirected balloon did decrease the risk of having rectal toxicity. But the amount that you got in the interior wall was significantly increased compared to before. And that's just because of the fact that you're in a way, pushing them to the mucosa up into the radiation field and getting the posterior lateral edges of the rectum out of the web. So another technique is used this space. You're creating hydrogen commercial announcer space or so. What we're doing here is that we we put this hydrogen between the prostate and the rectum in this very specific plan between the novus ASHA. And that allows us to have about 1.3, 7 years distance between the process and director from a radiation oncologist perspective that much of a distance is almost like a mile. And they are really really able to increase the dose to the posterior prospect without worrying about having any significant rectal. Uh the hydrogen will discipline about six months and it was FDA approved in 2019 following the trial. How do we do this? So this is done also in the office. So again this is the positioning where um the transferred to alter patients from the autonomy position a transfer to probe along with the spacer is placed into the patient's victim. And then you start visualizing of abuse here that we want to see. So you want to put the space variety in between the novus fascist. So you go ahead with the needle just like biopsy from the skin. You go in here with the needle and you find the space used failing to identify the correct space because you don't want to be into prosthetic capsule onto the rectum. It should kind of in a way breathe a little bit as you do in the hydro day section. Again, this isn't the transfers for you. You see the saline hydro distension and then you can start the hydrogen. This is how it looks again, about 1 to 2 centimeter distance here. And that will really protect your rectum having rectal toxicity. So the pivotal phase three clinical trial was the trial that allowed this to be um to be approved. Again, this was 2200 and 20 patients that were recruited from 20 U. S. Sites patients with intermediate or low risk prostate cancer were included in the trial. The application was distributed between kind of a third and a third and a third. One third patient had an internal general one third of the local one third under MAC. Again, the procedure's success for these patients was 99% in my hands. That quote patients that there's a 1998% success rate. About 2% will not be able to get one done because there's significant fibrosis in that space and safety. According to a trial, there was no significant device related event or no delays. Radiation treatment of infections, complications, no rectal alterations, importantly when you look here the space or really reduced the risk of rectal toxicity, Especially high grade electro toxicity to almost a minimum. And that's why I think radiation colleges are so excited about using this technique. So what about hydrogen versus the director balloons? So this is a study that was done um in china and the compared patients cabin radiation and how the patients fared between having this, the director balloon and the space force. So what you can see here and I want you to focus is actually the purple, which is the highest dose. So we don't under there is a significant decrease in the amount of radiation the director is receiving at the highest dose. And that's what we wanted really to see. And more importantly, when you look at the incidents of having um grade two or more rectal bleeding, there was really no increased risk in the patients with the with the space or so again, a significantly better technique that using the director balloon in these patients. And that's what we use primarily of So complications from the hydrogen. So, again, the trial said that there was no really complications associated with the procedure. But the reality is that they are and I think that this is um no matter that it was a systematic review that was done by the group. I yelled that looked at the reported complications to the the boston scientific uh following space replacement. And what you see is that over the years, the risks, the complications have become a little bit more severe. And the things that people become a little bit more liberal about using the space for. And I think that you have to be very, very careful when you're doing this. Again, I tell my patients are given the analogy that the space was the cherry on the sundae and the radiation being the sunday itself. I'm not gonna take the sunday by giving you the cherries. So if the procedure is not perfect, were extremely conservative about doing this. We can identify the good plane. We don't put the space. And the reason for that is because in patients with the jail is injected into the rectum. What is placed in the wrong place. It can cause a lot, a lot a lot of issues. And that can not only delay radiation, but as you can see from the complications cause significant quality events to these patients. So I think that hydrogen do add value are not going to create a ton of value for patients undergoing radiation treatment. I think that it reduces the rectal dose of the clinical trials have shown I think allows to increase the treatment those patients. And that's why I think a radiation colleges are really, really excited and that's because it's going to improve treatment effectiveness and you can really increase the dose to the prostate without worrying about increasing rectal toxicity. I think you're going to have a better kill zone and better control the cancer. I think that in here at Fox Chase we do a lot of salvage str prevents and I think that for those patients that we can we put a gel and I think that improves the safety of those patients having a second dose of radiation. And again, the procedure, to be honest, is pretty minimally invasive. Is an office based procedure, patients go home within 10 minutes of having a procedure done and really have no issues associated with the placement whatsoever. So in summary, um turn your various side effects are the primary driver for premium selection patients and prostate cancer. Bowel and rectal toxicity is the major factor leading to patient treatment related regrets. So again, that's why radiation colleges really really, really care about this issue. Space producing hydrogen have dramatically reduce the risk of rectal toxicity and the use of hydrogen has the potential to improve the delivery of radiation for the manager of primary and recurrent prostate cancer. So with that are in my talk and if you have any questions or comments, I'll take him Pakistan. Thank you very much for being here, appreciate it.