The PrecisionPoint™ Transperineal Access Systemdave@vi2021-10-23T20:04:19+05:00
Introducing the PrecisionPoint™ Transperineal Access System
Introducing the PrecisionPoint™
The PrecisionPoint™ Transperineal Access System revolutionizes the methodology for obtaining prostate biopsies. This medical system takes full advantage of the transperineal path to more thoroughly sample all regions of the prostate including those difficult to access with the transrectal approach. Since the technique is free hand, the practitioner can easily target the desired locations with certainty and through a single puncture of the skin.
In addition, the PrecisionPoint™ minimizes the potential for infection, since passage of the biopsy needle avoids the rectal wall contaminants entirely.
For the patient, this means no bowel prep or need to pre-medicate with antibiotics. The PrecisionPoint™ enables the practitioner to perform the biopsy under local anesthesia in a short duration procedure.
Former Boston Scientific executive Evan Brasington joins Perineologic
September 29, 2021 – By DANIELLE KIRSH
Corbin Clinical Resources’s Perineologic this week announced that it appointed Evan Brasington as chief commercial officer.
Brasington will be responsible for leading the Cumberland, Maryland–based prostate biopsy innovation company’s commercial strategy including operations, marketing, sales and distribution.
“We are very pleased to welcome Evan to the Perineologic team. He brings more than 30 years of leadership experience in the medical device sector, including planning and execution of global marketing and sales strategies to grow marketplace adoption of new technological solutions,” president and founder Matthew Allaway said in a news release. “Our company is dedicated to bringing patients a better, safer and more precise option for prostate biopsy, and Evan’s deep knowledge of the urology market will be invaluable in expanding adoption of the PrecisionPoint system in the years ahead.”
Prior to joining the company, Brasington held numerous leadership positions at Boston Scientific for 24 years and most recently served as a divisional VP of global market development, acquired technologies, urology and pelvic health. He has also held numerous leadership roles at Johnson & Johnson and PepsiCo.
“I believe very strongly in the work that Dr. Allaway and his team are doing and that Perineologic is well-positioned to shift the way clinicians perform prostate cancer biopsies with the innovative and proven-effective PrecisionPoint technology,” Brasington said. “We have the potential to transform prostate biopsy with an approach that is shown to result in better cancer detection and reduced infection rates”.
How I Developed The Next-Gen Prostate Biopsy System September 27, 2021 – By Matthew Allaway, MD, founder & President, Perineologic
Prostate cancer is the most common cancer in American men. Once prostate cancer is suspected, either through increases in levels of prostate-specific antigen (PSA) or a confirmatory MRI, a prostate biopsy is required to establish a diagnosis. The transrectal biopsy has been the standard of care for several decades, but it has limitations and presents several risks.
With this approach, a urologist passes a needle through a patient’s rectum to access the prostate, putting patients at risk of infection from fecal matter that can be introduced into the prostate with each pass of the biopsy needle. (The transrectal biopsy typically requires 12 needle sticks through the rectum to access the prostate for biopsy samples.) Generally, patients are given antibiotics to reduce the risk of infection, but due to societal overuse of antibiotics, up to 25% of bacteria are antibiotic resistant.(1) Approximately 1 to 6% of patients worldwide develop an infection resulting in hospitalization due to these infections, called sepsis.(2) Sepsis is a serious complication of infection and between 12 and 25% of cases are fatal.(3) Other potential complications of the transrectal biopsy are rectal bleeding, temporary inability to urinate, pain, and erectile dysfunction.(4)
Another concern with the transrectal approach is the limitations in sampling the entire prostate. Up to 30% of cancer is either not identified or misclassified.(5) Missing the cancer often leads to repeated biopsies, putting patients at risk once again of the associated complications. Misclassification could also result in patients being treated as having low-risk disease, when in fact, they harbor higher-risk disease that requires active treatment.
As a practicing urologist, I decided one day that these risks were unacceptable for my patients, and I would never do another transrectal biopsy. I knew there must be a better approach.
The Potential Of The Transperineal Approach
It was obvious that the best approach to a prostate biopsy was entering through the perineum – the patch of skin between the rectum and scrotum. The concept of passing a biopsy needle through the perineum was not new. About 40 years ago, before advancements in ultrasound technology, urologists would insert a specialized needle through the perineum to take tissue samples, guiding the needle with a finger in the rectum. But this approach was not very accurate and patient morbidity was significant following the procedure.
In early 2000, urologists retrofitted a brachytherapy grid-stepper and instead of using this to deposit radioactive seeds into the prostate, the biopsy needle was inserted to gather tissue samples. This method dramatically improved accuracy and eliminated the need to go through the rectum; however, the procedure can take up to 1 hour and requires general anesthesia. In addition, a patient’s perineum is punctured up to 60 times, resulting in a new set of potential complications.
How I Approached The Biopsy System Development Process
To address the risks associated with past methods, I developed a device and surgical method called the PrecisionPoint™ Transperineal Access System. This system uses a safer route for taking samples of the prostate by passing a biopsy needle through the perineum instead of the rectum. From there, the prostate is sampled thoroughly, with patients only experiencing two needle sticks and little or no discomfort. With this system, the risk of infection is reduced significantly (to nearly 0%) and it eliminates the complications of the transrectal approach.(6)
While my primary focus in developing the device was to eliminate the risk of infection for patients, another equally important benefit is that this system allows urologists to better access hard-to-reach areas of the prostate, including the anterior portion, resulting in nearly 30% better cancer detection rates.(7)
It is important in developing any device to keep the end user top of mind throughout the process. As a urologist, I knew that a new disruptive device would challenge the status quo of the prostate cancer biopsy landscape and thus it would need to be simple, reproducible, and easily taught for other urologists to be willing to adopt the technology. I would also need to distinguish the device from other technologies currently available – when most urologists hear the term transperineal, they imagine a grid-stepper and a complicated 1-hour procedure that presents several complications.
At first, I came up with a free-hand transperineal biopsy where I simply put a biopsy needle through a guiding needle and inserted it into the perineum. This was better than the transrectal approach but there was a significant learning curve with this technique, and it could not be standardized. It would take years of trial and error to develop the final design of the device, and during this time I faced challenges in taking any ideas from concept to prototype. Given that I did not have any engineering experience, it was key that I do my due diligence in finding third-party vendors and 3D printers to work with to make my ideas come to life.
Although the clinical objectives of PrecisionPoint posed several engineering challenges, they were satisfied by marrying design complexity and functional simplicity. The final system, designed and manufactured in the U.S., consists of three key components: an adjustable clamping mechanism, stabilization bars, and a carriage (with needle).
Adjustable clamping mechanism – The clamp is a familiar, easy design made to fit a variety of existing transrectal ultrasound probes of differing diameters. This feature makes it seamless for urologists to shift from the transrectal to the transperineal approach using their existing equipment. The clamp was also designed to prevent any movement relative to the ultrasound probe during the biopsy procedure and for easy removal post-procedure (via a release tab). The clamp was made to be longer on top to provide stability against rocking, and a specific gasket material molded onto the clamp was used to allow axial and rotational movement of the device relative to the ultrasound probe.
Stabilization bars – The stabilization bars are fixed to the clamping mechanism and allow the entire device to interface with the perineal skin and subcutaneous tissue. They needed to be designed to maintain their spatial relationship with the ultrasound probe and to withstand the movements required during a biopsy to allow sampling of all regions of prostates of all sizes while simultaneously allowing for potential mid-procedure adjustments. This required careful material selection and a design that held the access needle and carriage in place firmly but allowed the practitioner the ability to disengage and change position should they choose.
Carriage (with needle) – There are rails along the inner part of the stabilization bars to accommodate an adjustable sliding carriage. The carriage features five holes for a proprietary biopsy needle to pass through and allows urologists to choose which hole to use based on each patient’s prostate size. As the carriage slides down the rails, it allows the biopsy needle to advance deep into the perineal subcutaneous tissue. This component is key – it prevents independent movement while urologists take biopsy samples, ensuring stabilization and accuracy. The carriage was also designed with fits and features to protect patient safety, given the intimacy of the procedure. If excessive forces are applied to the device, the carriage (with needle) would disengage prior to harming the patient.
The components of the system allow clinicians to perform a transperineal biopsy free-handed, while being able to manipulate the biopsy needle in symphony with the ultrasound probe and have full control of the biopsy process. They can target the desired locations with certainty in a strategic and parallel direction. They are not restricted to biopsy locations as seen with a grid-stepper configuration. The free-handed technique also employs hand-eye skills intuitive to clinicians already performing transrectal biopsies, which often results in a short learning curve.
My system is also much more cost effective than a traditional biopsy system, because it replaces the outdated grid stepper approach that requires the use of a large and expensive contraption and the need for general anesthesia and more support staff.
Transforming The Future Biopsy Landscape
This new innovative system changes the paradigm of prostate cancer detection. It brings a more thorough, streamlined, cost-effective, and safer approach to prostate biopsies to urologists. It also makes it possible for urologists to perform a transperineal prostate biopsy in an office setting (using local anesthesia) without the need for operating rooms and costly hospital resources. But most importantly, increased cancer detection rates, reduced rates of infection and complications, and improvements in patient satisfaction make this innovative device essential to modern urology practice.
Liss M., et al. Prevalence and Significance of Flouroquinolone Resistance of E. Coli in Patients Undergoing Transrectal Ultrasound Guided Prostate Biopsy. J Urol. 2011;84: 395-99.
Loeb S., et al. Systematic Review of Complications of Prostate Biopsy. Eur Urol. 2013; 64: 876.
Fleischmann C., et al. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016; 193(3): 259-72.
Weiner A., The Cost of Prostate Biopsies and Their Complications: A Summary of Data of All Medicare Fee For Service over 2 Years. Uro Practice. 2020; 7(2): 145-51.
Szabo R., “Free-Hand” Transperineal Biopsy Under Local Anesthesia: Review of Literature. 2021: 35(4).
Lopez J., et al. Local Anesthesia Transperineal Prostate Biopsy Using a Probe Mounted TP Access System: A Multi-Centre Prospective Outcome Analysis. BJU International. 2021; 128(3); 311-18.
Ristau B., et al. Free-Hand Transperineal Prostate Biopsy Provides Acceptable Cancer Detection and a Minimum Risk of Infection: Evolving Experience with a 10 Sector Template. Uro Oncology. 2018; 36; 528.
About The Author:
Matthew J. Allaway, MD, is the founder and president of Perineologic, an innovative medical device company focused on developing and delivering technology to improve the safety, precision, and efficiency of healthcare options primarily in the field of urology. Many of the company’s philosophies and attitudes regarding patient care resulted from Allaway’s own personal battle with cancer, including his decision to become a urologist. He has been a practicing urologist and managing partner at the University of Pittsburgh Medical Center’s (UPMC) Urology Associates in Cumberland, Maryland, for about 20 years, with a focus on prostate cancer and female urology. He completed his residency in urology and surgery as well as his internship at West Virginia University. Allaway earned his doctorate degree from Midwestern University and his Bachelor of Science degree from Illinois Benedictine College.
Transperineal biopsy technology offers more efficient prostate cancer detection September 8, 2021 – Janelle Hart
In this interview, urologist Matthew J. Allaway, MD, gives an overview of transrectal vs transperineal biopsies, discusses how his own cancer battle influenced his professional path, and how his PrecisionPoint system aids in the detection of prostate cancer.
For many years, the transrectal biopsy has been the primary way for urologists to detect prostate cancers in their patients. This methodology, however, comes with risk of infection and inefficient sampling that has resulted in misdetection of cancers.
The PrecisionPoint Transperineal Access System (PPTAS) is the newest and first FDA-cleared technology from Perineologic that uses the improved method of transperineal biopsy to detect prostate cancers. The device’s development was led by Matthew J. Allaway, MD, founder and president of Perineologic, and urologist at Urology Associates, Cumberland, Maryland.
Please provide an overview of the risks regarding transrectal prostate biopsy.
The transrectal biopsy has been around for over 37 years, and recently it’s come front and center due to 2 major issues. The first is a pretty obvious one, which is the fact that since we have to put the biopsy needles through the rectal wall, which is contaminated with bacteria, there’s a risk of infecting the patient with their own fecal material. So, infection and sepsis are the most concerning complication, and the risk of sepsis will range anywhere from just below 1% to as high as 6%. Some of this depends on what part of the country you practice in and antibiotic-resistant patterns. The reason we’ve had more of an issue with the sepsis problem in the last 10 years compared with 30 years ago, is the reality that at that time, these gram-negative organisms were sensitive to the antibiotics that we were using. Now, there’s a much higher rate of antibiotic resistance. The second problem with the transrectal biopsy is the difficulty in sampling the anterior and apical regions of the prostate. Some estimates say that we miss up to 30% of cancers with the transrectal approach.
How does transperineal biopsy mitigate the problems seen with the transrectal approach?
Unlike the transrectal biopsy, there are many forms of a transperineal biopsy. In general, the transperineal approach is safer because the needles are passed through the perineal skin. So, we can sterilize that skin and if we enter through that passageway, we mitigate, if not eliminate, the risk of infection and sepsis.
What are some challenges or barriers to implementing transperineal biopsy?
The 3 major barriers we face are training, equipment, and reimbursement. The training and the methodology for a transperineal biopsy are very different from what we’ve been trained to do over the last 30 years. So, how do we help the urologists that are out there in practice with this technique? Well, it requires training in the form of peer-to-peer courses that the American Urological Association (AUA) has and some of the sectional meetings where there’s hands-on experience. The problem is a hands-on experience with phantoms and other simulators really doesn’t do the job by itself. It really requires a team of individuals going out there and working side by side with urologists. We’re also busy with our practices, so it’s extremely difficult to find the time to work on training or work on a new method. The second issue is capital equipment. Most urologists that switch to a transperineal approach may need to purchase some new ultrasound equipment or even a new ultrasound platform. There’s a financial aspect to that investment. And finally, our reimbursement system doesn’t take into account the increased time, training, and capital equipment purchases to make the switch. As a result, many of our early adopters are people that are quite passionate about doing the right thing for the patient and are willing to make those investments.
How did your own cancer battle inform your approach to prostate biopsy?
I’m very, very happy to be alive. I will say that. I give full credit to the fine doctors at Indiana University, and particularly Dr. Richard Foster, who was willing to do some pretty heroic surgery for this very rare case of testicular cancer that I had. After I went through that experience, which I still consider one of the best things that happened to me because it directed me into medicine and focused me on urology as a specialty, I always thought that I should make a contribution back to the profession. So, I did work in a research facility in our own practice. And finally, this whole idea of prostate diagnostics really landed right on my lap. I never thought that would be the area that I would dedicate the past 7 to 8 years of my career to focus on.
What is the PrecisionPoint system and how does it work?
The PrecisionPoint Transperineal Access System is the first FDA-cleared class 2 medical device specifically designed for performing a transperineal prostate biopsy. My challenges were to create a device and a method to perform this transperineal approach in an office setting under local anesthesia in a very time-sensitive fashion and also in a resource-clean fashion, meaning trying to use most of the existing supplies and equipment that a urologist currently has. We also wanted this to be compatible with our MRI ultrasound fusion platforms, and we wanted the procedure to be so safe that you could avoid the use of any antibiotic prior to the biopsy. This device will allow the urologist with their own hand control to anchor into the perinium through 2 small punctures in the perineal anatomy. Through these 2 small punctures, we can manipulate the device with the methodology to sample the entire prostate, both anterior apical and the posterior regions, where we find the vast majority of our cancers.
Is there anything else you feel providers should know about this topic?
If you look around the world, the European Association of Urology (EAU) has already changed its guidelines to include the recommendation of the transperineal approach for a biopsy as a first line approach. This is a very, very big change for a body of that size. So, in Europe, this movement of going to the transperineal approach has been, very successful, and most of the urologists are finding ways to get into this space rapidly. In the US, the movement has been a little bit slower; however, the attention to the transperineal approach has been found in all of our peer-reviewed journals. Pretty much on a monthly basis, you’ll find another manuscript about the transperineal approach. This is a generational change in how we’re going to do our prostate biopsies. I think it’s really time for us to do the right thing for our patients. The company that I developed around this product has been committed to traveling all through the country and the world, helping to train institutions and urologists both at our training facilities and at their own institutions. It’s an exciting change because it solves a couple of important problems. Some urologists will say, “I don’t really have an infection problem, I’m doing fine there,” but on the other hand, we need to look at the diagnoses of prostate cancer. We need to do a better job sampling the prostate and we feel strongly that the transperineal approach accomplishes these 2 very important goals.
Shortly after receiving a transperineal prostate biopsy, retired college professor Dr. Jim Kidd was diagnosed with prostate cancer – despite being told he was cancer free after undergoing a transrectal prostate biopsy.
Listen to the interview on Tri-State Today’s website (scroll to 38:30 to hear Dr. Kidd’s story in an interview with @Amanda Mangan, host of Tri-State Today): https://bit.ly/3zVlyTg
Transcript of Interview with Dr. Jim Kidd
Amanda Mangan: Welcome back into the program. I’m your host, Amanda Mangan and you know, we cover a wide variety of topics on the show. And several years ago, I had done a story on Dr. Matthew Allaway who’s a urologist at the University of Pittsburgh Medical Center’s, Urology Associates in Cumberland, and he created a safer and better biopsy approach called the Precision Point Transperineal Access System for helping to diagnose prostate cancer. And on the line with me is Dr. Jim Kidd, a retired college professor. And thank you so much for taking the time. I really appreciate it. So first off, tell me about how your experience started with this new procedure that was put forth by Dr. Allaway.
Dr. Jim Kidd: Okay. All right. Be glad to. A little bit of background is that I had been diagnosed well after the fact after his biopsy with sort of advanced prostate cancer. It began a couple of years ago. I had been watching my PSA over the years and then it and I in fact had a transrectal biopsy that didn’t show anything. The doctor said there was no evidence of cancer. That was about three years ago or so. So I went along and then had an appointment with my family doctor and he wanted to check my PSA and it had jumped to 20, which is fairly high. And he said, you know, we need to take another look at this. So in the meantime, I’d been looking at different procedures to check for prostate cancer and the different approaches.
Dr. Jim Kidd: And primarily the ones that are used, I found out on the east coast are transrectal. And I was not real pleased with that because I realized that there was a tendency to, or at least the possibility of having some kind of infections. When you go through an organ, that’s not the cleanest in the world. You can expect that occasionally there’s going to be some, some difficulties some infection that can take place. And I came across the perineal approach and I’m in Virginia. And so I thought, well, see if I can find a doctor that does that. And I happened to hit on the Dr. Allaway’s website and on his website this described it, of course what his approach would be. And then it said that he had trained doctors in different places. And I could inquire about that.
Dr. Jim Kidd: So being in Virginia, I looked for doctors in Virginia and found out that he had trained a doctor at the university of Virginia, but they were not up and ready to start that he said the training, in fact, a side issue. I found out that this year they have instituted his approach, I think, in their biopsies of the prostate, but at that time that wasn’t available. And so I called him and he said that at that time he said, I don’t think they started yet. He said, but if you want to come up here, he said, I had a cancellation. I may have called on a Friday and he said on Monday, he had a cancellation and he said, I would be pleased to do it. And I jumped at that.
Dr. Jim Kidd: And so my wife and I drove up to Cumberland and he looked at the information that came from UVA besides the fact that I’d had earlier biopsy that didn’t show anything. And then before I had contacted him, I also had an MRI and the MRI didn’t show anything, , there was no cancer that was obvious or was to be seen on the MRI. So that gave me some hope. And I went to see Dr. Allaway and he said, well, I’m looking at your information here that they sent me. He said, I don’t know that I think you have cancer or not that we’re gonna take a look. And so I went through the procedure, which is very benign. And as far as I was concerned, I was I usually, when I’m having those procedures, I say, at least put me under with twilight’s sleep or whatever they call that drug.
Dr. Jim Kidd: Anyway, he went through that and then he said, I’ll let you know, in a couple of days. So in a few days, he called, he said, well, I’ve got bad news and good news. The bad news is that we did find it. And the good news is, at least now we can start looking at treatment to give you a little understanding of why he was able to find that, most transrectal and the MRI was not able to get to a place where this cancer was. It was deep and high around the back of the prostate gland, and it was hidden by the pubic bone. And so the MRI didn’t see it. And the typical transrectal biopsy, the needle and the way they do it is not able to very easily get to that site.
Dr. Jim Kidd: And with his Precision Point procedure I was totally amazed and pleased that he actually did find it. Cause you know, I would have gone on without that, with this or the idea that maybe it’s just an infection or something like that. But I had as of Friday, this week, I completed my 28 days of radiation and now we’ll wait for a couple months to see if the PSA goes down to where it’s supposed to be and there’s no increase in PSA over time. So I’m, you know, positive about what’s going on right now. You know, it was I guess you might say a life changer to have him find that when the other approaches, if I’d had another transrectal, I don’t think they would have found it either. So that’s kind of a background to where I am.
Amanda Mangan: And so realistically this is such a critical procedure.
Dr. Jim Kidd: Absolutely. And I might say with that, there is no one that I know of. I play a lot of golf with a lot of guys who are older and I’ve decided that if I ever hear, if any of them they’re going for a biopsy, I will encourage them to go with this approach no matter where they have to go to get it, don’t do any more transrectal biopsies, make sure that they are able to go completely into the place where cancers often the most aggressive cause it’s hard to get to. Yeah, you’re right. It’s extremely important that it’s done correctly.
Amanda Mangan: And it’s important to be your own advocate sometimes too. Right?
Dr. Jim Kidd: Absolutely. I’ve read everything I could get my hands on about these approaches and also about, you know, what are you looking to do if you find cancer read everything you can about your options and at least be informed about what the possibilities are. All of them have their pros and cons and you just have to make a choice to see what’s there.
Amanda Mangan: What was it like working with Dr. Allaway?
Dr. Jim Kidd: It was a pleasure. I feel like I almost have a friend now. I’ve kept him abreast of what’s happening with me. And he has encouraged me to keep letting him know how things are going. And I’m amazed. I know he’s a busy man. He’s going all over the world and all over the states teaching people about his approach, but he’s just a fantastic person who would take time to just know and understand what’s going on with these patients. So, yeah, he’s a hero in my mind.
Amanda Mangan: How are you feeling now?
Dr. Jim Kidd: I feel great. I’m also on a drug that reduces testosterone, which is what a cancer feeds on. So you have to first address that to make sure you’re not feeding it with testosterone. But the only side effects might be a little bit of fatigue or that kind of thing, but it’s something I can work on. I can get around, I play golf six days a week. And so nothing’s really created a major problem for me.
Amanda Mangan: Anything else about your experience that you really think folks need to know about?
Dr. Jim Kidd: What I think, well, as I said, my feeling is that I would be an advocate for anyone I know that that needs to have a biopsy, or needs to look at that to make sure you have the one that’s most efficient in finding cancer. As I said, overstatement, but typical transrectal is probably not the way to go. I think it’s old school and it is, I think with time it will not even be used. And that I look for that to happen just in a few years.
Amanda Mangan: And to know that Dr. Allaway is, is working in this procedure here locally. It’s just really incredible.
Dr. Jim Kidd: Yeah. And to know all the work that he’s doing across the country and, and in cancer clinics, I think it’s speaking with him about two weeks ago that he is, I think in the majority of the cancer clinics who are doing biopsies and as he told me, he says, UVA has started up their procedure with the perineal approaches. There’s no reason not to. I mean, if you look at the statistics of infection that comes from the older approach, why would you go that way? There’s no logic to that at all.
Amanda Mangan: And the whole purpose is to make things as simple and easy as possible, realistically.
Dr. Jim Kidd: Yeah. And he’s, he’s got a device that limits, I think the number of what do you call it? I’m trying to think what the word has got, but when they take bits and pieces out of the prostate to look at it you know, you can take quite a few and still not find it, but his approach allows you to take, I think, fewer pieces of tissue out of the prostate and and be more extensive and going into areas where it’s not very often examined. And that is an area apparently which can contain some pretty aggressive cancer.
Amanda Mangan: Anything else that you want to get out there for folks?
Dr. Jim Kidd: No, I’d say that’s it. I think you mentioned it, you know, read everything you can about not only the biopsy, but also your options in terms of the pros and cons and there’s pros and cons on all of them. But I would assume that most doctors would do that if you sit down with them. But it’s pretty extensive understanding. I tend to think that doctors and it’s, it’s not a negative, but they have their own particular view. And depending which doctor you go, you’ll hear, you know, maybe one approach or the other. But I think if you read the literature and you’re interested in that, you want to know what all your options are.
Amanda Mangan: Definitely. Definitely. Well, thank you for sharing your experience. I truly appreciate your time.
Dr. Jim Kidd: Well, no problem. I’m glad to get the word out
Amanda Mangan: Again. That is retired college professor Dr. Jim kid, who is a patient of Dr. Matthew Alloway, a urologist at the University of Pittsburgh Medical Center’s, Urology Associates in Cumberland.
We look forward to joining the urologic community in highlighting the latest advancements in urology care and research at the Mid-Atlantic Section of the AUA’s 79th Annual Meeting. For those attending, be sure to visit Booth #108 to learn about the PrecisionPoint™ Transperineal Access System.
Dr. Matthew Allaway of Perineologic On The 5 Things Everyone Needs To Know About Cancer An Interview With Savio P. Clemente
More people are surviving cancer than ever before. Living with cancer is a reality, and we can still do most of the things we love to do while undergoing treatment.
Cancer is a horrible and terrifying disease. There is so much great information out there, but sometimes it is very difficult to filter out the noise. What causes cancer? Can it be prevented? How do you detect it? What are the odds of survival today? What are the different forms of cancer? What are the best treatments? And what is the best way to support someone impacted by cancer?
In this interview series called, “5 Things Everyone Needs To Know About Cancer” we are talking to experts about cancer such as oncologists, researchers, and medical directors to address these questions. As a part of this interview series, I had the pleasure of interviewing Dr. Matthew Allaway.
Dr. Matthew Allaway was born and educated in Chicago, Illinois before moving to Cumberland, Maryland 20 years ago with his wife. His practice and research have focused on prostate cancer diagnostics. He is also the founder and president of Perineologic, an innovative medical device company focused on developing and delivering technology to improve the safety, precision, and efficiency of healthcare options primarily in the field of urology.
Thank you so much for joining us in this interview series! Before we dive into the main focus of our interview, our readers would love to “get to know you” a bit better. Can you tell us a bit about your childhood backstory?
Science was always a subject of interest growing up. I became fascinated with the function and design of the world around me and was curious about what happens in the human body when affected by a serious disease or condition. I could appreciate how all of our organs work in harmony and how well our bodies can heal themselves in the best circumstances.
What or who inspired you to pursue your career? We’d love to hear the story.
A mentor of mine growing up, Dr. David Goldberg, influenced me at many levels and is likely the reason I went into medicine. We shared an enjoyment of learning about how systems in the body worked and how to fix them when damaged or impaired. As a radiologist, he was always intrigued by new technology and how to apply new scientific techniques to his work. I admired how much he enjoyed his career. If I could be as happy in this profession as he was, life would be great.
This is not easy work. What is your primary motivation and drive behind the work that you do?
Being able to help patients heal themselves from disease states is very satisfying. I really feel that I am able to make a difference. To be able to help tens of thousands of patients with an innovative medical device and surgical method has a very strong appeal. These life experiences continue to motivate me on a daily basis.
What are some of the most interesting or exciting projects you are working on now? How do you think that might help people?
Together with my team at Perineologic, we have been at the forefront of a generational shift on how prostate cancer is diagnosed, transitioning from the transrectal to the transperineal approach. The domestic and international urologic communities are now certain that the transperineal approach offers a better and safer prostate biopsy and that this approach will become the new standard of care. The concept of using an intuitive anatomic pathway, the perineum (the patch of skin between the rectum and genitals), will likely expand into treatments for a multitude of male and female urologic pathologies.
For the benefit of our readers, can you briefly let us know why you are an authority about the topic of Cancer?
I have spent that last seven years researching and developing a richer understanding of the prostate gland. More specifically, I have developed an appreciation of how and where prostate cancer develops in this multi-lobe and zoned organ. I have also been able to work side by side with some of the very best minds in urology. Sharing knowledge with others who are all trying to answer important questions about prostate cancer has given me a unique life perspective.
I used my experience as a urologist to invent the PrecisionPoint™ Transperineal Access System as a safer and more precise approach to performing prostate cancer biopsies. This is a disruptive technology in the urology sector because it simplifies prostate biopsies while also reducing the risks associated with the traditional approach. Historically, prostate biopsies are performed using the transrectal approach (inserting a needle through the rectum). But with PrecisionPoint we use the transperineal approach, which means clinicians insert a biopsy needle through the perineum (the skin between the rectum and scrotum) rather than through the rectum. The PrecisionPoint biopsy can be performed under local anesthesia in an office setting and involves only two needle sticks, whereas the traditional transrectal approach involves about 12 needle sticks. Most importantly, the transperineal approach with PrecisionPoint results in nearly 30% better cancer detection rates and a nearly 0% infection rate (compared to about a 5–7% infection rate with the transrectal approach). The transperineal approach with PrecisionPoint also reduces the risks of other complications including pain, bleeding and urinary retention. Patients are seeing the direct benefits of PrecisionPoint after years of hearing about the inconveniences, side effects and dangers associated with traditional prostate biopsy approaches. Developing the PrecisionPoint system has been extremely rewarding.
Ok, thank you for all of that. Let’s now shift to the main focus of our interview. Let’s start with some basic definitions so that we are all on the same page. What is exactly cancer?
Cancer is cellular growth gone haywire. All cells in our body have function and purpose, their ultimate expression is pre-determined and controlled by the human genome. When these cells lose their self-control mechanisms, they grow like a runaway freight train. This is how I see cancer.
What causes cancer?
Cancer is caused by damage, to one degree or another, that escapes our immune systems’ checks and balances.
What is the difference between the different forms of cancer?
Unregulated growth of cells is the common thread of cancer. However, how fast and where they will spread can vary from cancer to cancer. Some types of cancer grow slowly and may need minimal treatment while other types are aggressive and can spread quickly to other organs and areas of the body.
I know that the next few questions are huge topics, but we’d love to hear your thoughts regardless. How can cancer be prevented?
Every day, our immune system discovers cells that have become defective and risk cancerous spread. We need to maintain a very healthy immune system as it is our main defense system against disease. The healthier our immune system is, the better it can do its job. We also need to reduce the amount of destructive compounds that threaten to damage the genome resulting in rogue cellular behavior. Prevention starts with a respect for our bodies and thinking about what we put in them.
We need to understand what a healthy and balanced diet looks like. This will help all the cells of our immune system thrive and will minimize cellular damage to healthy organs. I am not only referring to diet, but the thoughts we have and how we react to the stress of life. Our psychological state will have certain negative or positive impacts on our risk of cancer.
We also need to understand genomic markers that we are born with that predispose us to cancer. Determining who is at risk earlier in life followed by creating more precise medical care and screening will result in better cancer prevention.
How can one detect the main forms of cancer?
Patients need to understand their bodies and listen. Most patients with good self-awareness will be able to tell their doctors something is wrong. It is important for patients to share any symptoms or changes in their bodies they have noticed with their doctors as they can be important clues that we can use to make a diagnosis.
Cancer can also be detected when a patient undergoes standard exams and tests during visits with their primary care physicians. For example, many men over age 50 will undergo a digital rectal exam and prostate-specific antigen (PSA) blood test during their yearly physicals. If either of these tests deliver abnormal results, their doctor may recommend further testing to find or diagnose prostate cancer.
A prostate biopsy is often the next step. There are two pathways to access the prostate for tissue samples — via the rectum (transrectal) or the perinium, the area between the anus and scrotum (transperineal). The PrecisionPoint system uses the transperineal approach, which is shown to be a better, safer and more precise method for prostate biopsy.
Cancer used to almost be a death sentence, but it seems that it has changed today. What are the odds of surviving cancer today?
This varies quite a bit as we compare types and grades of cancers to each other In general, patients with cancer are living longer with their cancers than ever before. Although cure rates have improved from many cancers, our ability to provide effective long-term treatments to patients who are unable to be cured has been an area of tremendous growth. As we improve our understanding of cancer, we will likely see more curative treatments in the future.
Can you share some of the new cutting-edge treatments for cancer that have recently emerged? What new cancer treatment innovations are you most excited to see come to fruition in the near future?
In general, treatments that target specific cellular pathways and minimize collateral damage are the most exciting cutting-edge innovations. Developing a better understanding of the human genome and the ability to screen for mutations will potentially lead to treatments that can be administered when the cancers are in their earliest stage and thus most vulnerable to effective treatments. I am also excited about the development of more accurate imaging modalities, which allow us to better asses the stage of different cancers in patients and help streamline cancer care.
Healing usually takes place between doctor visits. What have you found to be most beneficial to assist a patient to heal?
It is important for cancer patients to have a strong support system with access to nutrients and spiritual health to help with healing.
From your experience, what are a few of the best ways to support a loved one, friend, or colleague who is impacted by cancer?
In my experience, the best way to support someone you know who is impacted by cancer is not to ask how you can help, but to take action and do something special for them.
What are a few of the biggest misconceptions and myths out there about fighting cancer that you would like to dispel?
A general rule of thumb is that if it sounds too good to be true, it probably is. Ask your health care provider to research a treatment you have read about. Let them use their knowledge and experience to help you understand some of those treatments. The biggest myth is that we hold the cure for cancer but the pharmaceutical industry is keeping it from us so that they can make money on other treatments that do not cure. My priority as a health care provider is my patients and to ensure that they have access to available treatments as quickly as possible that may be able to improve their health and quality of life.
Thank you so much for all of that. Here is the main question of our interview. Based on your experiences and knowledge, what are your “5 Things Everyone Needs To Know About Cancer? Please share a story or example for each.
Cancer is not universally fatal. Prior to 1985, most men with testicular cancer died. Now more than 97% are cured! I would not be alive if it were not for the advancements in the treatment of testicular cancer.
Cancer treatments are not as toxic as they have been in the past. About 20 years ago, a patient with metastatic kidney cancer would certainly pass due to their disease. Now we have patients with metastatic kidney cancer living an additional 10 years with a very reasonable quality of life.
More people are surviving cancer than ever before. Living with cancer is a reality, and we can still do most of the things we love to do while undergoing treatment.
Screening is key. Screening is the best medicine, because the earlier we find cancer, the earlier we can treat and potentially cure it. Life after cancer treatment is as important as prevention. In the past, we were so excited to “cure” a patient, we failed to know how best to care for patients who may have a long life ahead of them after cancer.
You are a person of great influence. If you could start a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. 🙂
We need to shift our way of thinking from: not what can we do, but what should we do.
How can our readers further follow your work online?
More information about our work at Perineologic and the PrecisionPoint system can be found on our website, www.Perineologic.com or on our Twitter feed, @perineologic. Thank you so much for these insights! This was very inspirational and we wish you continued success in your great work.
The Daily Record announces 2017 Innovator of the Year winners
By Daily Record Staff 17 August, 2017
The Daily Record has announced its 2017 Innovators of the Year ̶ 26 individuals and companies who have created new products, services or programs that have had a positive effect on business, industry or the community.
Nominees were asked to complete an application that explained their innovation and the impact it has made on Maryland. The nominations were judged on four basic criteria: originality, power, challenge and value. For this year’s honorees, their innovative achievements took place between January 2016 and July 2017. “Innovators are constantly creating, improving and creating again. They make a huge difference in people’s lives, in the economy and in the success of our region,” said Suzanne Fischer-Huettner, publisher of The Daily Record. “The Daily Record is pleased to recognize this year’s Innovators of the Year and their passion, creativity and drive that result in new products and processes that have a positive impact on Maryland and beyond.”
The winners will be honored at an awards event Oct. 18 at the American Visionary Art Museum in Baltimore. For a complete list of honorees and event information, please visit the Innovator of the Year website.
27 Winners Announced at the 19th Annual Medical Design Excellence Awards (MDEA) Award Ceremony
Winners selected for groundbreaking work in the medical technology field
NEWS PROVIDED BY UBM Americas 13 Jun, 2017, 17:58 ET
NEW YORK, June 13, 2017 /PRNewswire/ — The Medical Design Excellence Awards (MDEA), recognizing the technological achievements of medical device manufacturers, announced the 2017 winners at its annual awards ceremony on the evening of June 13. Produced by the Medical Device and Diagnostic Industry (MD+DI), the MDEAs have recognized innovation in medical product design and engineering. Awards are granted across nine categories, announcing gold, silver and bronze medal winners in each category, in addition to naming the best in show and revealing the 2017 readers’ choice winner. The MDEA ceremony was sponsored by Philips-Medisize held in conjunction with Medical Design & Manufacturing (MD&M) East, which is taking place this week at the Jacob K. Javits Convention Center in New York, NY. To learn more about the MDEAs, please visit: mdeawards.mddionline.com
The MDEAs also awarded the prestigious Lifetime Achievement Award to Dr. Robert E. Fischell for his prolific contributions to the medical technology industry. Dr. Fischell is known for founding 15 public companies, and has developed over 200 U.S. and foreign patents, including groundbreaking work on heart pacemakers, defibrillators and coronary stents, and more.
“We believe that it is important to recognize those who are improving the lives of others through their innovative work through the MDEA’s,” said Jamie Hartford, editor-in-chief of MD+DI and director of content for Medtech Brands in UBM’s Advanced Manufacturing Group. “We are honored to celebrate these 27 award winners for their contributions to the industry.”
The winners are chosen by an impartial panel of judges comprised of clinicians, engineers and designers with years of experience in the industry. Judgement is based on five criteria, including design and engineering innovations, functional innovations, benefits to overall healthcare, benefits to patients, and competitive landscape. The 2017 MDEA Winners are as follows:
Digital Health Products and Mobile Medical Apps Gold: The Levo System–Otoharmonics Silver: TowerView Health Medication Management–TowerView Health Bronze: InPen Smart Insulin Delivery–Companion Medical Inc.
Drug-Delivery and Combination Products Gold: Neulasta® Onpro®–Amgen Silver: Halo Closed System Transfer Device–Corvida Medical Bronze: Probuphine–Braeburn Pharmaceuticals
ER and OR Tools, Equipment, and Supplies Gold: Savi Scout–Cianna Medical, Inc. Silver: PrecisionPoint Transperineal Access System–Corbin Clinical Resources, LLC Bronze: Signia Powered Stapling System–Medtronic plc
Gastrointestinal and Genitourinary Devices Gold: Dakota™ Nitinol Stone Retrieval Device with OpenSure™ Handle–Boston Scientific Corporation Silver: Eclipse System bowel control therapy–Pelvalon Bronze: Resolution 360™ Clip–Boston Scientific Corporation
Implant and Tissue-Replacement Products Gold: I-Ring–Beaver-Visitec International Silver: RIGIDLOOP™ Adjustable Cortical Fixation System–DePuy Synthes Companies Bronze: Belvedere Lateral Plating System—NeuroStructures
Nonsurgical Hospital Supplies and Equipment Gold: Gavi–Genea Biomedx Silver: Envella Air Fluidized Therapy Bed–Hill-Rom, Inc. Bronze: ivWatch Model 400–ivWatch
Radiological, Imaging, and Electromechanical Devices Gold: Geri–Genea Biomedx Silver: EyeOP1–Eye Tech Care Bronze: Hologic Affirm Prone Biopsy Table–Hologic Corp.
Rehabilitation and Assistive-Technology Products Gold: Linx–Endolite Silver: OASUS – Open Area Support System–Enliten, LLC Bronze: Eargo–Eargo
Testing and Diagnostic Products and Systems Gold: SAMBA–Diagnostics for the Real World Ltd. Silver: ePlex–GenMark Diagnostics, Inc. Bronze: FreeStyle Libre–Abbott Laboratories
by Michael A. Sawyers (Cumberland Times-News, Mar 1, 2017)
CUMBERLAND — As the use of a prostate-biopsy device invented by a Cumberland physician expands around the world, it is likely there will be fewer and fewer post-procedure infections.
“We can humbly say that since going to this technique we have had zero infections at our center,” said Dr. Matthew Allaway of Urology Associates on Williams Road.
Each year, there are 1.2 million prostate gland biopsies in the United States. There are are about 500 annually at Urology Associates.
Instead of guiding the sampling needle through the rectal wall, where fecal coliform bacteria can become attached and be transferred, Allaway’s device allows for an alternate or transperineal route to the prostate gland, not simply reducing subsequent infections, but avoiding them.
With this method, the pathway to the prostate is in front of the rectal wall, not through it.
“Some locations (using the transrectal approach) were seeing infection rates as high as 6 percent following biopsy,” Allaway said. “And these are life-threatening infections that almost always require hospitalization of two or three days. The usual case is that 36 hours after the biopsy there is a fever with chills and shakes.”
A year ago, when the Cumberland Times-News published a story about the device, clearance was being awaited from the Food and Drug Administration.
That clearance came a few months later.
“Following that article, we got calls from men in New York and Tennessee who wanted to come here for their biopsies,” Allaway said.
And, since FDA provided clearance, 5,000 devices — officially called Precision Point Transperineal Access System — have been manufactured and some are in use in various parts of the country.
Twenty-five physicians have come to Cumberland to be trained to use the device. They work at hospitals such as Johns Hopkins, Cleveland Clinic, MD Anderson Cancer Center in Houston and Rush University in Chicago.
Training typically lasts two days.
Allaway sometimes travels to other hospitals to provide training.
Dr. Mohammad E. Allaf, of the Brady Urological Institute at Johns Hopkins Hospital, sent Allaway a Tweet describing how well the device had worked and saying it would become the new standard of care for prostate biopsies.
The world headquarters of Perineologicwill open soon at 183 North Centre St. in Cumberland.
Allaway, president of the company, along with his wife, Kelli Allaway, chief financial officer, and John M. Hart, chief operating officer, have been frequent fliers to destinations where they describe the device to health care professionals.
“Our next trip is to New Jersey, but we have recently been to Ruby and Mon General hospitals in Morgantown and the Charleston Area Medical Center,” Hart said. “There are 100 meetings a year that we should be sending someone to for marketing and sales.”
The group’s trip planner includes visits to California and Kaiser Permanente, the biggest health system in the country, as well as to London and the 14,000-member European Urology Association and to Boston and the American Urology Association with 20,000 members.
A visit to Wales is in the rearview mirror.
Clearance to market the device internationally is anticipated in April, Hart said.
The device is being manufactured at Bridgemedica near Boston.
“We found out that FDA clears only 5 percent of the medical devices it evaluates,” Matthew Allaway said. “And Bridgemedica said the FDA clearance for our device was the fastest they had seen.”
Hart said potential markets include the United Kingdom, Ireland, Italy and Australia.
Manufacturing is the only aspect of the company that won’t take place in Cumberland.
“Distributing, marketing, sales and design will all take place here,” said Kelli Allaway. The group anticipates employing 10 to 15 individuals.
Not only does the device provide a safer route to the prostate, but results in a better cancer diagnosis, according to Matthew Allaway.
“We can sample the entire prostate, which couldn’t be done using the old method,” he said.
A (WARNING) graphic demonstration video is available on YouTube. As of mid-February it had been viewed more than 1.3 million times.
Hart said the company reached out first to the medical industry’s thought leaders, anticipating that the word would be spread to practitioners.
“But we want a public awareness, as well,” Matthew Allaway said. “We want a man who needs a biopsy to know that this new, healthier way exists.”
Doing a tissue biopsy of the prostate to detect cancer typically entails sending an ultrasound-guided needle about a dozen times through the rectum to collect specimens from the walnut-sized gland that sits under the bladder. The test carries an infection risk because the needle can take bacteria from the bowel into the prostate, bladder and bloodstream. Source: BSIP/UIG Via Getty Images
by Jason Gale
Doctors are changing their approach to prostate biopsies as evidence mounts that the danger of complications from the procedure may outweigh its usefulness identifying some cancers.
An increasing incidence of potentially lethal, difficult-to-treat bloodstream infections tied to prostate biopsies has become so serious that urologists are reassessing when, how and even if they do the procedure.
To reduce the risks, doctors are turning to a longer, costlier — but ultimately safer — approach to detect tumors that entails avoiding the bacteria-laden rectum. And though global evidence is scant, in Australia data shows doctors are scaling back their reliance on biopsies altogether. In the U.S., doctors say anecdotal evidence also suggests prostate biopsies are probably decreasing.
“People have started to sit up and say, ‘hey, maybe we need to rethink what we’re doing,’” said Nathan Lawrentschuk, an associate professor of surgery at the University of Melbourne and a urologist at Melbourne’s Austin Hospital.
The response reflects the growing threat of bowel-dwelling bacteria that even the world’s most powerful antibiotics are unable to snuff out. It’s also adding to the debate about the importance of diagnosing prostate cancer. While it’s one of the most common malignancies of men, tumors are slow-growing in most cases and treatment often causes impotence and incontinence.
Doing a tissue biopsy of the prostate to detect cancer typically entails sending an ultrasound-guided needle about a dozen times through the rectum to collect specimens from the walnut-sized gland that sits under the bladder.
The test carries an infection risk because the needle can take bacteria from the bowel into the prostate, bladder and bloodstream. The 15-minute procedure, usually performed in a doctor’s office under local anesthetic or light sedation, can be dangerous if the bacteria are resistant to antibiotics given at the time of the biopsy. Bacteria that escape into the bloodstream can cause sepsis, a condition that can lead to multiorgan failure and death.
“Greater recognition of the infectious risks of biopsy has led us to be much more careful about who we select for prostate biopsy,” said Stacy Loeb, assistant professor of urology and population health at New York University. “All patients should be evaluated for risk factors for resistant bacteria and infection, and should be counseled about the risks and benefits of proceeding to biopsy.”
The most common reason to perform a biopsy is an abnormal result from PSA screening, a blood test for a protein produced by prostate cells known as prostate-specific antigen. The test is controversial because, while it may signal the likelihood of prostate cancer, it can’t definitely detect it. Nor can it distinguish among benign tumors, slow growing cancers and deadly malignant ones. That’s led many doctors to question the wisdom of using PSA screening results to make treatment decisions.
“The risk of sepsis has made all of us think a little bit longer before recommending a biopsy,” said David Bell, head of urology at Dalhousie University in Halifax, Nova Scotia, adding that he tends to avoid the transrectal approach in repeat biopsies.
Bell says he’s now more tolerant of a slightly abnormal PSA and looks for other supporting reasons to indicate a biopsy is necessary, such as when PSA increases rapidly over time or is especially high. Other factors to consider include whether a palpable nodule develops, or if the patient has African ancestry or has a family history of early-onset prostate cancer or death from prostate cancer.
In Australia, the number of prostate biopsies performed per capita has declined the past three years from a peak in 2009, government records show.
More than 800,000 prostate biopsies are done in the U.S. each year. There isn’t good quality data in the U.S. to track frequency trends, New York University’s Loeb said. Anecdotal evidence, however, suggests the “overall number of biopsies is decreasing,” Otis Brawley, chief medical officer of the American Cancer Society, said in an e-mail.
The declining biopsy rate in Australia reflects concern about infection, as well as the availability of alternative tools, such as magnetic resonance imaging (MRI), to identify patients most likely to benefit from it, said Mark Frydenberg, head of urology at Monash Medical Centre in Melbourne.
“The best way to minimize the risk is by not having a biopsy at all,” Frydenberg said. “If you do need a biopsy, then the decision rests between going down the transperinealroute or transrectal route.”
The perineum, the skin between the bottom of the scrotum and the anus, is a safer entry point because it can be cleaned with antiseptic, unlike the rectum, said Lindsay Grayson, Austin Hospital’s head of infectious diseases.
The lower risk of infections means urologists can take more core samples of the prostate, especially of the part of the gland that’s difficult to reach from the rectum, Frydenberg said.
On the downside, the procedure takes at least twice as long to perform, requires heavier patient sedation, six people in an operating theater, and equipment costing about $100,000, he said.
No studies have examined the infection risk from prostate biopsies globally. Instead doctors are trying to gauge the scope of the problem from studies emerging from North America, Europe and Asia.
The chance of being hospitalized within a month of a biopsy increased fourfold in Ontario in less than a decade, reaching 4.1 percent in 2005 from 1 percent in 1996, Robert Nam and colleagues at Toronto’s Odette Cancer Centre, wrote in a study published in the Journal of Urology in 2010. Almost three-quarters of the hospitalizations were infection-related.
“Given the recent spike in infection complications after prostate biopsy, the ideal method to diagnose prostate cancer must be pondered,” Matthew Gettman, professor of urology at the Mayo Graduate School of Medicine in Rochester, Minnesota, wrote in an editorial in the journal European Urology last May. “Despite local anesthetics, the whole procedure is barbaric, and it is surprising that the issue of infection has not come to light years ago.”
Infectious complications have typically occurred in 3 percent to 5 percent of prostate biopsy patients at Austin Hospital, Lawrentschuk said. Doctors have sought to curb rising rates of infection by using increasingly powerful antibiotics. The problem is resistance is building to even the broadest-spectrum drugs, forcing doctors to look for other ways to minimize risks. “That’s huge,” said Brawley, of the American Cancer Society.
“You do hear these anecdotal reports of deaths, but I have only heard of one in Melbourne in the last three or four years,” Lawrentschuk said. “In terms of sepsis and admissions to the ICU, they seem to be more common. Even if the sepsis rates aren’t higher, the stakes are higher because you are getting organisms that are trickier to treat.”
The Moffitt Cancer Center in Tampa, Florida, has revised its biopsy protocol over the past two years with the help of infectious disease physicians to minimize complications, said Wade Sexton, a urologist and director of the hospital’s urologic oncology fellowship program.
In addition to being as selective as possible with initial biopsies and repeat procedures, the center now performs rectal swabs on every patient undergoing a prostate biopsy within one month of the procedure to make better informed choices about what antibiotics to use based on any resistant bugs found, Sexton said.
“This is a step we’re taking to try to minimize the risks as best as possible until additional evidence becomes available,” he said. “Whether this approach is cost-effective remains to be determined.”
Patients who have traveled to South Asia, Southeast Asia and other regions where there is a high incidence of infections caused by multidrug-resistant bacteria are told to wait at least six months from their return to have a prostate biopsy, Lawrentschuk said. Where there is a more urgent need, travelers are given a different antibiotic — one from the last-resort class known as carbapenems.
Doctors are also testing fosfomycin, a broad-spectrum antibiotic discovered in Spain in 1969, for its ability to penetrate the prostate. Preliminary results of research carried out at Austin Hospital suggest it’s promising, Lawrentschuk said.
Alex Carignan a,*, Jean-Franc ̧ ois Roussy a, Ve ́ronique Lapointe a, Louis Valiquette a, Robert Sabbagh b, Jacques Pe ́pin a
a Department of Microbiology and Infectious Diseases, Universite ́ de Sherbrooke, Quebec, Canada; b Department of Surgery, Universite ́ de Sherbrooke, Quebec, Canada
Background: An increasing risk of infectious complications following transrectal ultrasound–guided prostate needle biopsy (PNB) has been observed recently in some centers. Objective: To delineate the risk factors associated with post-PNB bacteremia and/or urinary tract infection (UTI) and determine why this risk has risen over time.
Design, setting, and participants: A case–control study in a Canadian tertiary-care center. Cases were all patients who developed bacteremia and/or UTIs after PNB between 2002 and 2011; controls were randomly selected among patients who under- went a PNB without such complications.
Outcome measurements and statistical analysis: Crude and adjusted odds ratios and their 95% confidence intervals were calculated using logistic regression. Results and limitations: A total of 5798 PNBs were performed during the study period, following which there were 48 cases of urinary sepsis (42% with bacteremia). The incidence increased from 0.52 infections per 100 biopsies in 2002–2009 to 2.15 infections per 100 biopsies in 2010–2011 ( p < 0.001). Escherichia coli was the predominant pathogen (75% of cases). Among 42 patients whose post-PNB infection was caused by aerobic or facultative Gram-negative rods, 22 patients (52%) were infected by pathogens resistant to ciprofloxacin. Independent risk factors for post- PNB infection were diabetes, hospitalization during the preceding month, chronic obstructive pulmonary disease, and performance of the biopsy in 2010–2011. In 2010–2011, the minimal inhibitory concentrations for ciprofloxacin increased com- pared with 2002–2009 ( p < 0.03). The major limitation of the study was its retro- spective hospital-based nature, which hampered data collection on outpatient antibiotic prescriptions.
Conclusions: In the past 2 yr, ciprofloxacin resistance contributed to the increasing incidence of post-PNB infections in our center. Novel antibacterial prophylaxis approaches need to be evaluated. Crown Copyright # 2012 Published by Elsevier B.V. on behalf of European Association of
Urology. All rights reserved.
* Corresponding author. Department of Microbiology and Infectious Diseases, Universite ́ de Sherbrooke, 3001, 12th Ave. North, Sherbrooke, Quebec, J1H 5N4, Canada. E-mail address: Alex.Carignan@USherbrooke.ca (A. Carignan).
John Michael DiBianco, Jeffrey K. Mullins, Matthew Allaway
There is growing interest in the use of transperineal prostate biopsy due to the advantages of decreased infection risk and improved cancer detection rates. However, brachytherapy stepper units and templates may increase costs and operative time for the practicing urologist. We present the safety, feasibility and early outcomes of a single urologist’s experience with ultrasound guided freehand transperineal prostate biopsy as an alternative to transrectal ultrasound guided biopsy.
A retrospective review of all prospectively performed ultrasound guided freehand transperineal prostate biopsies between January 1, 2012 and April 30, 2014 was performed. Primary outcome measurements were safety and feasibility.
A total of 274 ultrasound guided freehand transperineal prostate biopsies were performed in 244 patients. Operative and total operating room use times were 7.9 and 17.5 minutes, respectively, with an average of 14.4 cores obtained during each procedure. The overall cancer detection rates for all procedures, those in biopsy naïve patients and those performed for active surveillance were 62.8%, 56.4% and 89%, respectively. New diagnoses of prostate cancer occurred in 41.2% of patients with 10% positive after a previous negative transrectal ultrasound guided biopsy. Complications (Clavien grade I or greater) including systemic infection, urinary retention and hematuria or pain requiring physician or hospital intervention did not occur.
The use of ultrasound guided freehand transperineal prostate biopsy for the suspicion or surveillance of prostate cancer is feasible and safe. The results were encouraging with respect to the primary outcome measurements. Ultrasound guided freehand transperineal prostate biopsy with the patient under local anesthesia is currently under investigation. Large, prospective, randomized, multiple operator studies to evaluate the comparative effectiveness of freehand transperineal prostate biopsy and transrectal ultrasound guided biopsy techniques are recommended.
To read more at Urology Practice Journal, click here.
Dr. Allaway discusses the PrecisionPoint system on the podcast Record.Talk.Listen. (Originally broadcast on June 5th, 2016.)
by Michael A. Sawyers (Cumberland Times-News, Mar 3, 2016)
CUMBERLAND — A Cumberland urologist is in great demand these days, traveling to places such as the Cleveland Clinic, University of Michigan and MD Anderson Cancer Center in Texas to explain a safer, more accurate prostate biopsy method he perfected and a new device to perform the procedure.
“I have been told by highly placed people that it could change the standard of care,” said Dr. Matthew Allaway, seated this week in his office at Urology Associates on Williams Road.
Instead of guiding the sampling needle through the rectal wall, where fecal coliform bacteria can become attached and be transferred, Allaway, in a few hundred patients, has used a transperineal route to the prostate gland, not simply reducing subsequent infections, but avoiding them.
With this method, the pathway to the prostate is in front of the rectal wall, not through it.
“Some locations (using the transrectal approach) were seeing infection rates as high as 6 percent following biopsy,” Allaway said. “And these are life-threatening infections that almost always require hospitalization of two or three days. The usual case is that 36 hours after the biopsy there is a fever with chills and shakes.”
In addition to being safer, the transperineal method is a more accurate detector of prostate cancer, according to Allaway.
Allaway has thus far used a free-hand approach to the transperineal method of prostate biopsy. He guides the ultrasound tool with one hand and the needle with the other. In May, that is likely to change.
“The free-hand method is tricky and can be intimidating (to physicians),” he said.
Allaway created a one-piece device that provides ultrasound imagery and needle penetration.
“We have the patent and are awaiting (Food and Drug Administration) approval that the device is safe to use,” Allaway said. “We expect a product launch in May.”
Allaway created a company to produce the devices. They will be manufactured in New Hampshire, but much of the other business related to the product will be Cumberland-based.
“We will train surgeons here to use the device,” Allaway said. “Sales, marketing and distribution will all take place here in Cumberland.”
Treating prostate cancer is vital, according to Allaway.
“We’ve never cured a person once the cancer has escaped the prostate, though we have been able to prolong lives,” he said.
Data from 2010-2012 show that 14 percent of men will be diagnosed with prostate cancer in their lifetimes.
Allaway’s next stop on his tour to explain how outcomes can be improved for those who have their prostates biopsied will be the United Kingdom.
A men’s health discussion with Dr. Allaway on the podcast Record.Talk.Listen. (Originally broadcast on November 1st, 2015.)