The movement to make transrectal biopsies go extinct: The Man behind TRexit
By Howard Wolinsky
Back in the early 20-teens, Associate Prof. Jeremy Grummet, MD, then a junior consultant in urology at The Alfred Hospital, Monash University in Melbourne, Australia, recalls men who had undergone transrectal biopsies frequently becoming septic.
“It would be an unusual week if there wasn’t at least one patient who was in hospital with sepsis after a prostate biopsy. It wasn’t noticed. It was, ‘Oh, this is just what happens,’” he said.
“I thought that was crazy because we’re the doctors, and we’re causing the sepsis. It’s what we call iatrogenic or doctor-caused. I saw these guys on the ward. They were genuinely suffering in terms of their extremely high fevers, feeling absolutely horrid, and having uncontrollable shakes or rigors.”
Like most doctors who are now critics of the transrectal biopsy, a routine procedure since the late 1980s, Grummet cared for a patient who landed in an intensive-care unit with transrectal biopsy-caused sepsis and nearly died.
“I thought this was insane. He was a perfectly well man prior to the biopsy that I did on him,” he said. “And, to add insult to injury, the biopsy result was negative. He didn’t even have prostate cancer.”
Grummet has been one of the leaders of an international movement called TRexit, or transrectal exit, to end the use of the transrectal approach by 2022 and to improve stewardship of antimicrobial agents, a crutch often used to treat or prevent sepsis that experts now worry causes antibiotic-resistance and in future will leave no defenses against dangerous infections.
(See “TRexit 2020: Why the time to abandon transrectal biopsy starts now,” https://www.nature.com/articles/s41391-020-0204-8)
This group contends that transperineal biopsies — pokes through the easily sterilized skin of the perineum — as a safer alternative. Grummet has conducted research showing that when TP is performed, infections and sepsis virtually disappear. (https://pubmed.ncbi.nlm.nih.gov/27987032/)
Doctors in Australia, Norway, the Netherlands, and the United Kingdom have been leaders in dumping transrectal biopsies in the name of patient safety.
Grummet said that in his state of Victoria and much of Australia, transrectal biopsies have gone the way of the Tasmanian tiger.
It can take a public outcry in the media to persuade the public to vote with their feet and pressure doctors to switch to safer procedures.
Grummet said the Sydney Morning Herald in 2013 (https://www.smh.com.au/healthcare/prostate-biopsy-blamed-for-preventable-superbug-deaths-20130924-2uc8r.html) warned of the risks of transrectal biopsies and abuse of antibiotics.
Patients began selecting urologists who performed transperineal biopsies over those who didn’t.
Grummet said change does not come or easily or quickly for physicians set in their ways.
“You have to learn a new procedure. It’s a change to our routine,” he said. “Once you get into a slick routine, where you’re very efficient, and you can plow through cases quickly, you don’t want to change it. And no one likes to muck with that.
“But, if patients say, ‘Do you do transperineal biopsy?’, and you say no, and they go to another doctor, that will change your practice in a heartbeat. I think that was a large part of what happened here in Australia, and it was very effective.”
Australia’s national health plan, Medicare, recently implemented a policy in which doctors are paid more for performing transperineal biopsies and are docked for performing transrectal biopsies.
Grummet said, “Reimbursement is a great way of changing practice. It really forces peoples’ hands. It’s the same stick really as patients threatening to see other doctors because it’s a loss. When it all boils down, it’s a loss of income for all practitioners. It’s a pretty powerful incentive. If the evidence base supports it, well, then I’m in favor of it.”
In January, the European Association of Urology (EAU) announced new guidelines making transperineal biopsies the preferred approach.
Grummet serves on the EAU Prostate Cancer Guidelines Panel. And USANZ (the Urological Society of Australia and New Zealand) endorses the EAU Guidelines.
Truls E. Bjerklund Johansen, MD, who led the movement in Norway to make transperineal biopsies the preferred approach, serves on the EAU Infection Guidelines Panel. (See “Death by Prostate Biopsy”: https://howardwolinsky.medium.com/death-by-prostate-biopsy-5b5bb9c0bf5a)
Grummet said the inference of the EAU guidelines is that transrectal biopsies are substandard because of the risk of sepsis and because they require “a heavy-handed use of antibiotics, which completely goes against everything that WHO and Center for Disease Control and Prevention say about the need to avoid unnecessary use of antibiotics at all times, particularly the fluoroquinolones, which are typical antibiotic use for transrectal biopsy prophylaxis and certainly the carbapenems, our last line of defense. We do not want to be using them unless strictly necessary.”
How are things going with a TRexit USA?
Slow motion at best. But there are some signs of change.
Johansen said he presented the case against transrectal biopsies in 2019 at the American Urological Association meeting. Based on his research in Norway, he estimates that 2,000 American men a year — out of 2 million biopsed — die from sepsis. The connection between transrectal biopsies and deaths from sepsis are often buried deep in death records.Urologists don’t make the connection between their biopsies and sepsis deaths that occur days later.
Johansen said his American colleagues greeted him with skepticism.
There is plenty of denial still going on. Many otherwise progressive urologists have their heads firmly buried in their rectums on this issue.
I had an email discussion with a young urologist trained in one of the most prominent urology programs in the world. I had asked her to sign a petition I wrote to encourage the American Urological Association (AUA), the Center for Medicare Services, and commercial insurers to support a move from transrectal biopsies to transperineal biopsies.
A prominent past president of the AUA and a high-level executive of EAU along with other major figures signed my petition to urge change in the U.S. http://chng.it/7bQsWSfK
My friend politely declined: “In my clinic, sepsis rates are less than 0.5% post-prostate biopsy. I haven’t done a recent side-by-side comparison of transperineal vs. transrectal prostate biopsy risks, but I don’t think that transperineal is overall better nor feasible on a large scale. I have found transrectal biopsy to [have] minimal discomfort (if done thoughtfully and gently).”
Biopsies have been a frequent topic in my A Patient’s Journey blog on MedPageToday.com. (See “No more Men Need to Die from Transrectal Prostate Biopsies”: https://www.medpagetoday.com/special-reports/apatientsjourney/92201 and “Prostate Cancer Surveillance: Could I Be Done With Biopsies … Forever,” https://www.medpagetoday.com/special-reports/apatientsjourney/85971)
That’s because transrectal biopsies are a major concern for me and others on active surveillance for low-risk prostate cancer who face a series of biopsies to surveil our cancers.
I decided four years ago that I was getting off the biopsy train. Based on some British research, I was persuaded that mpMRIs would be the best way to monitor low-risk prostate cancer. My urologist disagreed at the time.
I told my urologist that unless doctors like him changed, they’d have a revolt on their hands on the part of men on AS. He basically said “tough,” that he needed a way to monitor these cancers, and targeted biopsies were the way to go, not standalone mpMRIs.
But he’s changed. He now agrees with my approach — at least for me. And if my PSA shoots up, I can undergo a transperineal biopsy with local anesthesia in his office because he just switched. It’s four years and counting since my last transrectal biopsy after six biopsies in six years.
I am a journalist. But over the years, I also have become a reluctant activist. This role doesn’t rest easy on the shoulders of an old-school journalist.
I have organized webinars on TP vs. TR for patient groups, including Active Surveillance Patients International (I am a co-founder) and a pioneering virtual support group I helped launch for AS-only from AnCan/Us Too.
The attendees — patients and their partners — are now questioning urologists about when they will switch to the transperineal approach. But even the most progressive urologists are resisting change, waiting for the AUA to endorse new guidelines and for reimbursements to be updated.
A support provider — I hate the word “caregiver” — who attended one of the sessions told me of a meeting she had with one of the biggest names in urology today.
The researcher said his hospital’s ORs are filled to capacity and have no extra time or capacity for TPs. Well, he seems to be unaware or ignoring the fact that the modern transperineal approach can be performed in an office setting, and advanced-practice nurses can perform them — at least in the United Kingdom.
He also told my friend that TPs are more painful than transrectal procedures — a subject that is much debated amongst urologists. She retired: “Probably not as painful as sepsis. He didn’t answer but grinned a bit.”
Meanwhile, the AUA is considering changing its early detection guidelines. A source on the committee told me AUA likely will shift away from TP eventually, but the process will not be overnight. Another source told me that the education side of AUA is preparing materials to train members about transperineal biopsies.
AUA could follow a template from EAU’s January 2021 position paper that states: “Available evidence highlights that it is time for the urological community to switch from a transrectal to a transperineal [prostate biopsy] approach despite any possible logistical challenges.” https://www.sciencedirect.com/science/article/pii/S0302283820308083
Christine Frey, a spokesperson for AUA, said: “The AUA is in its early stage of developing a clinical guideline on the Detection of Prostate Cancer and is reviewing the benefits/harms of transrectal v. transperineal biopsies as part of the guideline. While we cannot say yet what any recommendations will be in this space until the guideline is complete, rest assured this topic is being discussed and will be addressed in the forthcoming guideline.”
AUA is holding a debate on TP vs. TR at its annual meeting in September in Las Vegas.
Meanwhile, if Johansen’s numbers are right, about five American men a day die from sepsis caused by transrectal biopsies, a semi-elective procedure.This must not go on,
I believe transrectal biopsies eventually will become a relic from barbaric days in the past. I also believe that liquid biopsy will be the wave of the future, even for low-risk disease,
Meanwhile, patients need to let their urologists know that they would prefer transperineal biopsies in the interest of safety and health. The AUA needs to update its guidelines, and insurers need to look out for the well-being of their patients by reimbursing urologists more for performing transperineal biopsies.
Grummet said: “It’s been extremely gratifying actually to be involved in part of advances in prostate cancer diagnostics. It’s genuinely exciting when I walk in the ward today. I haven’t seen a prostate biopsy sepsis literally for years, whereas I used to see it probably every week.”
`That’s the way it’s supposed to be.
Howard Wolinsky is a Chicago-based freelance medical reporter. He has been on active surveillance for low-risk prostate cancer since December 2010. He has written A Patient’s Journey blog for MedPageToday for four years, His medical reporting has won awards from the National Press Club, the American Public Health Association, the American Bar Association, and the Association of Health Care Journalists. The Chicago Sun-Times twice nominated him for a Pulitzer Prize. His new book, “Contain and Eliminate: The American Medical Association’s Conspiracy to Destroy Chiropractic” is available at ContainandEliminate.com