Dr. Matthew Allaway, DO, urologist at Urology Associates, talks about how the precision point biopsy for prostate cancer makes the biopsy safer and easier to recover from.
Interview conducted by Ivanhoe Broadcast News in July 2022.
This was born out of a lot of experience, clinical experience with patients, right?
ALLAWAY: Yeah, it was. So the genesis of the idea, it started back in 2013. There were two big problems with diagnosing prostate cancer through a prostate biopsy. Those two big issues were the infectious complications because with each passage of the biopsy needle, and there were 12, you know, you’re putting the needle through fecal material, through the rectal wall, piercing into the prostate, which is highly vascular. And so you’re basically injecting the patient’s own fecal material into their bloodstream. So we had to give these big antibiotics to prevent it. Well, you know, we’ve now hit the post-antibiotic era where what used to work is not working as well. So we’re having a lot of – we’re having breakthrough infections and sepsis. Sepsis is when it’s a life-threatening infection in your bloodstream. So those patients, about 12% of patients with sepsis, could die. So that’s a big problem. And there were lots of other solutions, you know, like you could mitigate the risk by adding more antibiotics, targeting antibiotics through rectal swabs, but it was just making something so simple, so complicated. So we had that problem and the fact that we knew we were missing relevant cancers because our standard biopsy was the trajectory and where the prostate sits in regards to the transrectal approach. The angles were off. In order to get to areas where we knew cancer was hiding was very tricky to do. It could be done, but it wasn’t done standard. So those two problems led me to think, you know, there’s got to be a better solution. And the answer is to go through the perineum. And that was sort of the idea. And then one day I said, I will never do a transrectal biopsy again, but I got to find out a better way. The idea of going through the perineum wasn’t a new concept. I mean, back in 1920, we did all of our biopsies through the perineum without an ultrasound – just with a finger in the rectum and a big trocar through the perineum and kind of navigate. Very barbaric and bloody and painful, and you had no way of seeing what you were biopsing. So – but the idea of going through the perineum was always the better angle. So what we just did was reinvented the whole biopsy by taking all the good aspects of old transperineal, even some of the positive aspects of transrectal, and trying to repackage it, reengineer it, and make it something that could streamline and mainstream approach.
So how does it work?
ALLAWAY: Oh, before that. OK. So in order to make the transition from transrectal to transperineal and make it the standard of care, the procedure has to be done ideally in an office setting in a time frame that’s similar to transrectal. So you know, 10-minute timeframe, 10 minutes. It has to be tolerable by the patients or more tolerable. And we have to use existing equipment. For the most part, resources and tools that we’ve always used. Because as urologists, I mean, I was designing something for the urologist by a urologist, so I knew what challenges it was going to take to make the transition. So what I engineered was a way to anchor into the perineum through either one of two punctures, and then through those individual puncture access points be able to manipulate the entire device and ultrasound system and actually shift the anatomy so that we could in a almost in an X, Y or Z axis, we could reenter the prostate at any angle we desired. So the secret sauce was the perineal scruff. So just like, you know, your dog, you grab the dog by the scruff, it’s that redundant tissue on their back. It doesn’t really hurt. You can grab a puppy by the scruff, lift them, you could shift it all over the place. Well, the perineum, I realized, had a scruff. It was the skin, the subcutaneous tissue that glides on the pelvic floor fascia around the prostate. And I knew we could anchor that tissue, and then we could manipulate it and actually even to form the prostate with it to basically hit any location in the prostate within a millimeter or two of accuracy every time. And that’s really – so, you know, it’s, you know, simple elegance is what it really has done. You can’t make it – you can’t make a procedure that’s the most common procedure done in urology, one of the top two, you can’t make it too complicated. You can’t make it robotic and, you know, overengineered it because this is a procedure that has to be quick, easy and affordable for the masses. So we engineer with those details in mind.
So the device that you designed, is it patented – you have a patent or is it FDA approved?
ALLAWAY: So it was – it’s a big journey. It is the first class-two medical device cleared for free-hand transperineal biopsies. So, the FDA has three classes. Class two is one that kind of invades the anatomy to a certain degree. So we had to get through the FDA, which is arduous. We then had to protect the secret sauce. So we’re holding six U.S. patents, including a method patent. Because it’s not just the device; the method and technique is just as important as the device. And that’s what we teach as a company, you know, how to use the device, but really how to move your hand and how to – the methodology of getting the biopsy needles into the relevant zonal anatomy.
Why have it done this way?
ALLAWAY: Well, you know, one of the nice things about this technique, urology is innovative as it is – BPH treatments, cancer treatments, incontinence therapies, always on the leading edge of new technology. But in my 25 years of being in urology, a lot of technologies, they either don’t work for everyone or they – it’s kind of a passing phase, often moving on to something else. What’s nice about this technique and device is that once urologists dive in and learn the method, you know, there’s almost no turning back. It’s not like, well, I use this for these patients and I use the old technique. It’s like it’s a complete, you know, shift in practice pattern. The other aspect to your question is the fact that, you know, the patients are very happy because you don’t have to even get a dose of antibiotic. We don’t recommend an antibiotic prep at all. One dose of an antibiotic or multiple antibiotics for one dose carry risk. You know, allergic reactions, c diff other problems. No antibiotics needed. No bowel prep needed. So the patient could literally just have it sight unseen. You know, just hop up on the table and we’re going to do it. The tolerance of the procedure is actually really well accepted. Once the urologist learns the method, you know, the patient walks away often saying, boy, when I had my transrectal, this was actually better or well, better tolerated, or at least equivalent in the other cases. Then they walk away also knowing when we do a proper sampling of the prostate this way, if the patient’s pathology report says you do not have cancer, we’re more confident that you do not have cancer. With older methods, there was a lot of well, it was negative, but, you know, patients going through three or four of these biopsies over 20 years, can’t find cancer. Got to go back and do another biopsy. It just gives nice closure so the patient’s very happy about that.
How accurate is the rate with this kind of a biopsy?
ALLAWAY: Well, with this biopsy, once you’re trained and competent in the skills, I could stand at the ultrasound screen and point to one area and say, I want you to land the needle right there, and you should be able to land there. In fact, there’s no area of this three-dimensional spherical structure that we shouldn’t be able to get the needle right on. So really, one, two millimeters of accuracy. As long as you can see the spot on the ultrasound screen and you’re trained on the method, you should be able to fly right into that location.
How many practices are using this?
ALLAWAY: Well, we’ve got – in the U.S., we have over 500 urologists trained. And the nice thing is that urologists then teach other urologists. So, you know, we’ll teach, you know, a initial group, cohort of urologists, train them. And then their partners come in and say, we’d like to learn, also. So they start spreading it. So there are more trained than we’ve even trained, but this is just the numbers we’ve trained. There’s been over 150,000 men biopsied this technique. But we’re just scratching the surface because there’s anywhere between 1 million and 1.7 million of these procedures done just in the U.S. But outside of the U.S., we’ve made tremendous growth, too. So it’s not just an American experience, too.
Can you talk to me a little bit about Rick, your patient? What was his situation?
ALLAWAY: So Rick is, you know, he’s the patient that he’s done his homework. He’s researched. He knows what’s out there. And he has a high expectation that we’re going to use, you know, the latest innovative approach. He wants the best. But he’s also a great patient because he has a trust in his doctor and he had a trust in me as a urologist. So it was like we could exchange our concerns. We didn’t just jump right into a biopsy. You know, we took our time. We mapped out his PSA changes over time until we were convinced there was a trend of concern. It wasn’t as if his PSA was sky high and there was no doubt he had cancer. There was still, you know, this idea that maybe you don’t have a cancer at all, maybe it’s just enlarged prostate. So I enjoyed the experience with Rick because it keeps me on my toes. But I was happy because we had already been so many steps ahead of others as far as advancing the field so that when it came to his biopsy, we were able to use all of the integration of MRI that he had had prior into his biopsy workflow, so he got the best of diagnostic and procedural aspects. And, again, he hopped up on the table and we just did local anesthesia, and he was like, wow. You know? And it was really a pleasure. And he also represents the kind of patients we’re really – you know, when we talk about prostate cancer, there’s a lot of, well, you know, do we need to do this? Are we over treating? And the answer is yeah. In many cases we over treat. In many cases, maybe we shouldn’t be screening certain patients at a certain age or other health problems. But Rick is the guy who has – he’s retired. He’s got a lot of years ahead of him and he wants quality of life. And, you know, we found a cancer that was definitely a threatening cancer at the right time early on. And based on our mapping, you know, that we did on his prostate, everything we saw that we knew he had was confirmed in his final pathology, which was also very nice. Because a lot of times you’ll do a biopsy and you’ll see the result. And then if the patient goes on to have the prostate removed, you’ll look at the report and you’re like, it’s like apples and oranges. Like, I had much worse disease than I thought. Everything matched exactly what we thought. So it was – I mean, it was really kind of what we expect. The perfect flow of information, communication, informed consent, quality experience, great results and a great outcome.
Is there anything I didn’t ask you that you would want to make sure that people know?
ALLAWAY: I think the most important message to patients is that everything that we did, you know, 15 years ago in urology to screen men, to biopsy them, to treat them, I mean, we’ve completely revamped our approach. You know, now we know where the problems were. We know where we needed to improve. We’ve made those improvements. So I think we’re in a much better place now for men to feel confident that they should have their prostates checked. They should be screening for prostate cancer. And knowing that there are better, safer options to get them from point A to point B. It’s just a different world now.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Kelli Allaway
Sign up for a free weekly e-mail on Medical Breakthroughs called First to Know by clicking here
