‘Great Biopsy Debate': Is 'Big Urology' ready for biopsy reform? Porsche vs. Honda biopsies?

My admittedly biased commentary on transperineal biopsies. Your views?

By Howard Wolinsky

Two leading urologists conducted an excellent debate on August 29  on transperineal vs. transrectal biopsies at a webinar sponsored by the AnCan Virtual Support Group on Active Surveillance.

Dr. Deborah Kaye, of Duke University, favored transrectal biopsies. Dr. Arvin George, of the University of Michigan, argued for transperineal biopsies. Both put up spirited and well-reasoned positions and rebuttals.

Please view the program and reach your own conclusions.

This was a debate mainly designed to educate patients and their families and potentially their doctors on transperineal vs. transrectal biopsies.

Before the debate, we took a snapshot of what type of prostate biopsies the approximately 150-member audience had undergone.

Most only had transrectal biopsies (69%). Sixteen percent had undergone transperineal biopsies—and in some cases also transrectal biopsies.

Actually, that’s a high number for TPs. Nationally, only 5% of the 2 million men a year who have prostate biopsies follow the transperineal route, which is not widely available in the United States.

So this is not a typical audience.

Actually, we don’t know if the debaters’ arguments swayed the audience. But it was clear that nearly half (48%) wanted their next biopsy to be a transperineal vs. 22% who said transrectal is the way they’re going next time. Thirty percent had no preference or were unsure.

This gives us a sense of which way the biopsy winds are blowing. And I suggest the winds are blowing in favor transperineal biopsies.

I arranged the debate and served as moderator. I tried to maintain neutrality in that role. I hope I succeeded.

But for full disclosure: As an advocate for active surveillance for men with low-risk to favorable intermediate-risk prostate cancer, I also am an advocate for transperineal biopsies (TP). But if no TP is available, when appropriate, I recommend transrectal with warnings about potential risks.

Just so you know my bias.

I had six biopsies in my first six years on active surveillance. I had no problems. Have I been dancing between the raindrops? Have I been lucky?

I haven’t had another in the past six years, and my urologist doesn’t think I’ll ever need another biopsy because my PSA levels are stable.

But I feel I can see the future.

American urologists may not be ready for it, but I expect a transperineal future in the name of patient safety though it may take a while for the docs to accept reform. 

Wishful thinking? Not really.

The European Association of Urologists (EAU) last year made transperineal biopsies the preferred biopsy in Europe and also Australia. In fact, veteran urologist Hein Van Poppel, chairman of the EAU’s new policy office, told me in a recent interview that transrectal biopsies in effect are considered “malpractice” in Europe--I should note that dramatic position vehemently rejected by both Kaye and George.

Van Poppel told me the EAU’s position basically comes down to safety issues and concern about microbial resistance caused by overuse of antibiotics as in the case of prostate transrectal biopsies, or antibiotic stewardship.

The EAU decision came on the heels of the widely publicized case of a Norwegian man who died from a transrectal biopsy.

(Death by biopsy was front page-news in Norway.)

Van Poppel is consulting with the European Council for Europe-wise guidelines, which then would be adopted on a country-by-country basis.

The AnCan debate covered the issues that the American Urological Association likely will tackle in reviewing its 2017 position on biopsies, favoring transrectal biopsies and mentioning older techniques of transperineal biopsies secondarily as acceptable.

Let’s hear from Drs. Kaye and George. I’ll be throwing in my views, too. It’s my newsletter so I can do that.

Kaye’s arguments boiled down to:

--Transrectal biopsies are tried and true and do the same job as transperineal in detecting prostate cancers, maybe better, so why change things? In other words, if it ain’t broke, why fix it?

--Transperineal biopsies are more costly. They take up more of the urologist’s time and reimbursement levels for urology fees are the same. Kaye compared transperineal biopsies to fancy Porsches while transrectal biopsies in her mind are a more practical Honda Civics.

Transperineal Porche?

Transrectal Honda Civic?

--Transperineal biopsies, which push needles through the anesthetized area between the scrotum and the anus, are more painful than simply pushing needles into the prostate through the rectum.

George argued in summary:

--Transperineal biopsies do a better job of detecting cancers because they can be more easily deployed to hard-to-reach areas within the prostate. So more cancers are found with TP.

--Transperineal procedures are safer because they avoid sepsis, which may kill up to nearly 2,000 American patients per year, and cause other infections requiring expensive hospitalizations.

--Increased pain levels are a red herring. Pain levels are heightened momentarily as local anesthesia takes hold. Besides, general anesthesia can be performed in an operating room--though that clearly increases costs.

(I think Kaye may have overstated this point. Anecdotally, most patients I know who have had both said the pain is comparable and not a big deal—though some patients find the thought of pain intolerable and ask to be knocked out with TP.)

Let’s look at this in more detail. Again, please listen to the debate and decide for yourself.

Kaye said TP is  “trendier and cooler, but it is more painful. It is more expensive. It has equivalent cancer detection rates. It’s less efficient. It’s not generalizable across practices. In comparison, transrectal has improved patient experience, it’s less expensive. It has comparable infection rates and cancer detection. It's more efficient and more sensible all around.”

She used her memorable car comparison.

Kaye said: “For me, I like to compare (TP)  to a Porsche versus a Honda. Yes, the transperineal is equivalent to a Porsche Carrera 911 and the transrectal is comparable to a Honda Civic. Yes, I would a lot of the time like a Porsche Carrera more often than a Honda Civic until it gets time to fix it. Overall, the Honda Civic just makes more sense. The TRUS (transrectal ultrasound) biopsy is the gold standard. It’s endorsed by the American Urologic Association.”

It’s a fun analogy. Very memorable. But does it hold up? Also, note: AUA in 2017 endorsed transrectal but in 2023 will be reviewing its guidelines. More on this shortly.

In her introduction, Kaye said: “My opponent is likely to argue that infection rates are so much lower with transperineal over transrectal but it’s just simply not the case. Old transrectal biopsy techniques, yes, infection rates were fairly high, between 5-6%. But now, current transrectal biopsy techniques should limit infections to less than 1%.

“In fact, some series demonstrate infection rates of 0-0.1% using techniques such as augmented prophylaxis and needle disinfection. … Data from my opponent’s own institution demonstrate post-infectious hospitalizations of .63%, so very, very small. There is a lot of data to suggest that infection rates are incredibly low with new techniques on the transrectal approach.”

She said that efforts to prevent infections from transrectal have been having success, including using rectal swabs to determine if the patient has any antibiotic-resistant organisms and responding with appropriate, targeted antibiotics.

Kaye noted: “There are studies that demonstrate no differences in infection rates between transperineal and transrectal. Once again, my opponent will probably stress all the differences in infection rates between the two techniques, but it just isn’t true based on the data.”

She said: “My opponent is also probably going to argue that transperineal biopsies are better for antibiotic management. Transperineal biopsies use fewer antibiotics than transrectal biopsies. Unfortunately, that is just simply incorrect. Antibiotics are still being used regularly for transperineal biopsies. There is a theoretical benefit, but we know it hasn’t been met yet.”

George countered that if a severe infection occurs, especially sepsis but other infections near the prostate as well, patients can land in the hospital, which is not only potentially life-threatening but very costly. He cited new research from Norway and Germany showing that antibiotics are not necessary for transperineal procedures—though it is true that some urologists with an abundance of caution still use antibiotics.

He urged the audience to be aware that admissions for infections after a prostate biopsy in multiple studies where they’re doing transperineal biopsies was 0.056%. “Virtually, you eliminate the risk of an infectious hospitalization,” he said.

George said: “0.09% of men who undergo a prostate biopsy will die from that prostate biopsy. Now, this is a morbid statistic about that and even though this number seems exceedingly low, if we take into consideration two million people undergoing a prostate biopsy per year, that is almost 1,800 men dying from a prostate biopsy annually. And the vast majority of these are most likely due to an infection or sepsis. Even though this rate is low, it should be an absolute never event especially given the fact that we have the tools to virtually eliminate infections and also infectious hospitalizations or sepsis.

(My two cents: I have written about death by prostate biopsy before. Urologists simply don’t believe it. In “No More Men Need to Die From Transrectal Prostate Biopsies— A movement toward transperineal biopsies” in MedPageToday, I wrote last year: “The old maxim holds that doctors bury their mistakes. In the case of deaths by transrectal biopsies, mistakes often may be buried under a misleading cause listed on death certificates. Doctors don't often link deaths from septic shock to transrectal biopsies performed a few days earlier.” Urinary tract infection makes it on the death certificate. But no one explores the likely cause of the infection—a transrectal biopsy.)

George warned about bacterial resistance, especially to the antibiotic fluoroquinolone, widely given to men undergoing biopsies,

He said: “They are a category of antibiotics that urologists tend to lean on because it does have a favorable profile in regard to its ability to penetrate the tissue and work well in dense tissues and also that it concentrates highly in the urine. But as providers, we’re really victims of abusing this antibiotic ubiquitously. We use antibiotics such as Ciprofloxacin or Levofloxacin and what has resulted is that we keep driving more and more antimicrobial resistance. You may have heard of the term superbug? That’s essentially what we’ve been generating. We throw more antibiotics at the problem and we end up in the same scenario that we started in.”

Antibiotic-resistant bacteria also can add to deaths in the long run, he said.

(Me again: Kaye warns about costs. So far, the class-action lawyers haven’t latched on to this issue. But they are always on the outlook for the next asbestos. Will transrectal biopsies be next after their Camp Lejeune campaign is done? Stay tuned.)

Kaye said, “Not many people want to be laying in the doctor’s office with stirrups with a probe up their rectum a long time, so having a fast and efficient biopsy technique is much better for patient care.”

She added that if men find transperineal biopsies “miserable,” it will be harder to maintain them on AS because they can undergo serial biopsies over the years.

Kaye takes a practical approach to making a switch to transperineal, which was designed for office settings but also can be performed in a hospital OR, where the patient goes under general anesthesia.

She said: “Transperineal is not generalized with most practices. Frequently, clinicians will use sedation such as nitrous oxide. They frequently need clinical OR suites that aren’t readily available in many practices across the country. And also require specialized staff. So, once again for the same result, a patient has to be more inconvenienced, go somewhere other than the typical doctor’s office, undergo risks of anesthesia and/or sedation, and take off more time from work with a transperineal biopsy approach.”

(My view: European and Australian urologists have made the switch. Why can’t American urologists? There are obstacles. Money is a big one. It can cost $40,000 for a urology office to get set up for TP. In addition, TP uses more of the urologist’s limited time while reimbursement is not increased.

(Also, Australia’s national Medicare health plan pays urologists a higher rate for performing transperineal biopsies, doubling the fees. Aussie patients argued the extra pay is in the interest of promoting patient safety. Advocates for transrectal often point out that TRUS uses less doctor time and fits better into their workflow. Should those arguments trump patient safety?)

George said: “I know that Dr. Kaye stressed the sedation and the non-office aspect of it, while I don’t see that as a tremendous benefit from a patient perspective, maybe there could be arguments from a provider perspective. There is the ability now to routinely perform it under local anesthesia. And virtually all my biopsies are done with a local anesthetic, the transperineal biopsies especially.”

He showed an image of a man undergoing a TP, “You can see that this person is rock still. They are extremely comfortable during the procedure,” he said. “They’re not jumping about. They’re not flinching at all. The local anesthetic that we use is extremely, extremely effective. So, we give some anesthetic to the skin first ... in addition to local anesthetic closer to the prostate. That bright area that you are seeing there is the needle going in and allowing us to give local anesthesia directly to the prostate.”

You should listen to the point and counterpoint and come to your own conclusions.

Several in the audience asked where they can find a urologist who offers transperineal procedures. Good question.

I know a guy from New Mexico who drove 1,200miles or so to Rochester, Minnesota, just for a transperineal biopsy. We all can’t or won't do that.

It isn’t easy to find a TP doc because most U.S. urologists aren’t trained to do them. That is gradually changing. AUA meetings offer courses on TP.

A friend in Australia told me urologists here were recently asked to answer a survey on transrectal vs. transperineal biopsies.

A Canadian doctor told me that urology is like any other business. He said the customers (we patients) need to make our desires known about biopsies whatever they may be. If we want transperineal biopsies, we should vote with our feet--our hearts, minds, and prostates will follow along with business-savvy and safety-smart urologists.

The change to TP was made overnight in Norway after a newspaper expose of a man who died from sepsis triggered by prostate biopsy.

A major factor in the U.S. will be what the AUA recommends next year as it reviews its guidelines. That work has begun behind closed doors.

As advocates and patients, eventually, we’ll have an opportunity to have our voices heard. When the time is right, we should let the AUA know what we think.

What will the AUA do?

Your guess is as good as mine. Research findings on TP v. TRUS will play a big role. I suspect the dollars and cents and the logistics of reform also will be considered.

Mathias “Paddy” Bauler, a colorful and corrupt Chicago alderman and saloon keeper,  used to say: “Chicago ain’t ready for reform.”

Is “Big Urology” ready for biopsy reform?

A change will go down easier if AUA can lobby Medicare and reimbursement coders for increased pay for transperineal procedures. That’s a separate process from writing guidelines.

In the end, I hope AUA and urologists come down on the side of patient safety not the cost of running urology practices.

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Thanks to my transcriptionist Nancy for turning around the transcript of the debate so quickly.

Actually, Nancy has become an expert on AS and related topics. She said she loved the AnCan debate.

So I asked her opinion on who won.

She said: “​​I think transperineal is the winner but they need to improve a few things. It seems safer. But I was surprised to hear that transrectal is so close to TP regarding the infection rate.”

I’d like to hear what you think. You can respond via email or in the comment box on the newsletter’s web page.

I have not charged for subscriptions. But I do pay Nancy. So if you can, and if you feel inspired, please subscribe. No pressure.

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Active Surveillance 101 course launches at ASPI meeting

ASPI will be premiering the first of a new video series named "Active Surveillance 101" at noon Eastern on September 24, 2022.

Like 101-level courses in colleges, AS 101 is aimed at teaching the basics. In this case, it's the basics of active surveillance, close monitoring of low- to favorable intermediate-risk prostate cancer.

The program features conversations between actual patients and their partners/spouses and leading experts. The goal of this series is to reach all AS candidates, including those who have not yet been diagnosed with prostate cancer but have rising PSAs (prostate-specific antigen) blood levels and offer them an introduction to AS and help them formulate questions when they go to their family doctors, urologists, or oncologists.

Register here: ASPI SEPTEMBER ZOOM MEETING

The first episode features a couple, Nancy and Larry White, in a simulated office visit with Dr. Steve Spann, a top family physician and dean of the University of Houston College of Medicine. They discuss Larry's rising PSA and what it may mean.

In subsequent episodes, the couple visits Dr. Laurence Klotz, of the University of Toronto, the "father of active surveillance." Other episodes of AS 101 are being developed on biopsies, imaging, and DNA testing. Dr. Jonathan Epstein, the guru of Gleason scores from Johns Hopkins, has agreed to meet with Larry and Nancy, too.

AS 101 is sponsored by the Active Surveillance Coalition, which includes Active Surveillance Patients International, the AnCan Virtual Support Group for Active Surveillance, Prostate Cancer Support Canada, Prostate Cancer Research Institute, and TheActiveSurveillor.com newsletter. We encourage you to share this series with anyone you know who is dealing with this issue, including your family physician.

View the ASPI session on genetics

Men and their families can learn valuable facts from a cancer genetic test. While the use of genetics testing for cancers is still growing, the existing state of the art for prostate and related cancers is a powerful tool for identifying men and persons at risk. This 60-minute expert presentation features Robert Finch, MS, a certified genetic counselor, of Myriad Genetics,  and medical oncologist Michael Glode, MD. The video is available at https://aspatients.org/meeting/