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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.
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.
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.
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.
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.
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.
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.