Transperineal vs. Transrectal Prostate Biopsy: Significant New Developments

In our BOB Tales newsletter last month, we told readers about BOB member “Lee” who shined a light on a serious problem associated with the standard transrectal biopsy procedure routinely performed around the world every day. This prompted several emails from members who had similar experiences. One informed us of a new and relatively unknown technology that virtually eliminates the sepsis infection problem. This piqued our interest, so we followed up on the lead. And we’re glad we did.

Our research revealed that about two million Americn men undergo conventional transrectal biopsies each year and up to 2,000 of them die from the procedure, mostly from sepsis infections, not to mention bleeding complications associated with the procedure. Hospitalization for sepsis costs between $9,000 and $19,000 per patient according to Richard Szabo, MD at the University of California, Irvine.

The Journal of Endourology reports “many centers around the world have adopted fTP-Bx (“free-hand” transperineal prostate biopsy) because it virtually eliminates sepsis, may improve detection rates of clinically significant prostate caner, and can be easily integrated into a normal clinic workflow using only local anesthesia.” The journal also reports that if all urologists in the U.S. abandoned transrectal biopsies for transperineal biopsies, “the potential savings in healthcare costs of complications would be significant.”

The PrecisionPoint™ Transperineal Biopsy

Deb and Bob met via Zoom with Dr. Matthew Allaway, a urologist and inventor of the PrecisionPoint™ transperineal biopsy device and procedure, along with Ken Knudson, CEO of his new company, Perineologic, and Evan Brasington, CCO. Following is what we learned from the meeting.

Over the past 18 years, Dr. Allaway has been caring for men, women, and children with a myriad of urologic conditions in the small town of Cumberland, MD. “As a urologist,” he said, “I treat a wide spectrum of conditions that span from urinary infections and kidney stones, to cancers of the kidney, bladder, and prostate using modern advancements to improve outcomes. I’m committed to contemporary screening methods for prostate cancer and the potential benefits of early diagnosis and patient-directed treatments.” 

The conflict he struggled with was accepting the known complications and limitations with the most important first step in the treatment of prostate cancer, the prostate biopsy. Once prostate cancer is suspected, either through an increase in PSA and/or confirmatory prostate MRI, a biopsy of the prostate is required to establish the diagnosis of prostate cancer. Almost two million prostate biopsies are performed in the U.S. each year. Dr. Allaway’s research and efforts have been devoted to developing a better, safer biopsy for prostate cancer.

The Standard Biopsy and Associated Risks

The current standard of care for a prostate biopsy is a transrectal ultrasound-guided (TRUS) biopsy. It requires the urologist to take samples of the prostate by passing a needle through the rectum of the patient in order to access the prostate. This procedure runs the risk of infecting the patient with fecal matter introduced into the prostate with each pass of the biopsy needle. Generally, patients are given antibiotics to reduce this risk, but due to societal overuse of antibiotics, up to 25 percent of bacteria are resistant to the antibiotics given.

The trans-rectal biopsy typically requires 12 needle sticks through the rectum to access the prostate for biopsy samples. Dr. Allaway said, approximately 1-6 percent of patients worldwide develop a serious sepsis infection requiring hospitalization. Some publications place the sepsis infection rates higher. One article from the Sperling Prostate Center reported TRUS biopsy caused infections as high as 7.2 percent. Another study published in the U.S. National Library of Medicine reported urosepsis following TRUS prostate biopsy to be even higher. “Sepsis is a serious complication of infection and between 12-25 percent of cases of sepsis are fatal,” said Dr. Allaway. “Other serious complications of the transrectal biopsy are injury to blood vessels of the rectal wall resulting in rectal bleeding. Less serious risks include temporary inability to urinate, pain, and erectile dysfunction. I decided these risks were unacceptable for my patients,” he told us.

His second concern with the transrectal approach was the limitations in sampling the entire prostate.  “Up to 30 percent of cancer is either not identified or mis-classified,” said Dr. Allaway, “Missing the cancer often leads to repeated biopsies in order to capture the cancer, exposing the patient once again to the complications. Misclassification could result in the patient being treated as having low-risk disease, when in fact, they harbor higher-risk disease that will need active treatment.”

A Better, Safer Biopsy

To address these risks, Dr. Allaway developed a device and surgical method called the PrecisionPoint™ Transperineal Access System (PPTAS) which allows the urologist to perform the prostate biopsy in a revolutionary way that eliminates the complications and risks associated with the transrectal method of biopsy. “This system uses a safer route for taking samples of the prostate by passing an access needle through the perineum or taint. From there, the prostate is sampled thoroughly with the patient experiencing only two needle sticks and little or no discomfort,” said Dr. Allaway. “The risk of infection using this approach is reduced to nearly zero and the complications of rectal injury are eliminated.” 

While his major focus was to eliminate the risk of infection, another equally important benefit of this approach presented itself. That benefit included better access to difficult-to-reach parts of the prostate gland during the biopsy, resulting in nearly 30 percent better cancer detection rates. “We’ve treated more than 3,000 patients in the Cumberland area with this method and have had patients visit us from around the world to have their biopsies in our clinic.”

The New Standard of Care?

The revolutionary PrecisionPoint method is quickly being adopted around the world. Twelve of the 15 U.S. News and World Report’s top-rated urology centers are using the PrecisionPoint Transperineal Access System. Additionally, 12 countries outside the U.S. are using the device and method. Many of the countries have made the commitment to eliminate the transrectal biopsy and use the PrecisionPoint biopsy as the standard of care. 

“We are working to make the PrecisionPoint biopsy the standard of care throughout the U.S. so that all men can have the benefits of a better, safer biopsy and relegate the trans-rectal biopsy to the medical archives,” Dr. Allaway said. “We’re expecting more than 40,000 prostate biopsies in the U.S. will use PPTAS technology in 2021.”

Educating Urologists and Patients

Men and their family members are becoming aware of the options and are requesting the transperineal approach. Unfortunately, over 90 percent of biopsies in the U.S. are still performed using the transrectal pathway. Many urologists simply are not aware of this transperineal option and therefore patients are not informed of their options. Outside the U.S., the transrectal method is being actively phased out and the European Association of Urologists have changed their guidelines, recommending that the transperineal biopsy be offered. 

“We intend to continue our mission by training urologists on the PPTAS, educating patients and working with insurance carriers, Medicare, and the American Urologic Association to offer the very best and safest biopsy.”

Transperineal biopsies are not new. They have been done before, but the procedure involved the use of a stepper device to penetrate the perineum 18 to 24 times and it required general anesthesia. And while this procedure resulted in far fewer infections, it was expensive, time consuming and therefore never gained wide popularity and use.

The PrecisionPoint technique uses a new device that is relatively simple to use, requires only two punctures of the perineum for multiple biopsy samples and can be done under local anesthesia. The procedure is done in roughly the same amount of time as the TRUS procedure and costs about the same with the addition of a $200 disposable PPTAS device.

One urologist we spoke with about the PrecisionPoint transperineal biopsy called it a “game changer.”

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