In 2018, a 68-year-old Norwegian stonemason named Roar Gulbrandsen died after undergoing a routine transrectal biopsy.
When the cause of death was determined to have been a massive, preventable infection, Gulbrandsen’s daughter, Agnes, helped lead a campaign to abandon transrectal biopsies in favor of transperineal biopsies ― a safer but at the time less widely employed approach.
The result: Severe infections, including sepsis, and deaths have all but disappeared since the shift, according to a new study presented last week at the European Association of Urology (EAU) 2023 Congress in Milan.
Dr Truls Bjerklund Johansen
“We have shown that switching to transperineal biopsies can bring deaths and infection rates to zero,” Truls Bjerklund Johansen, MD, who’d performed the biopsy on Gulbrandsen and worked with the man’s daughter to change national practice, told Medscape Medical News.
Bjerklund Johansen, professor emeritus of urology at the University of Oslo, and his colleagues found that annual deaths in Norway that were linked to transrectal prostate biopsies fell nationally from fewer than 20 in 2017 to zero in 2021–2022 as transperineal biopsies caught on in that country. Their figures were based on follow-up data from 99,196 biopsies from the period of 2008–2017 and 36,550 biopsies from 2017–2022 reported to the National Norwegian Patient Registry.
The national rate of severe infections, including sepsis, resulting in hospitalization dropped from 6.8% in 2017 to 0.5% in 2022. In Oslo County, where the transrectal biopsies had been phased out earlier than in the rest of the country, no cases of infections or deaths occurred in 2021 and 2022.
Twenty annual deaths after transrectal biopsy in Norway, which has a population of 5.5 million people, corresponds to 1230 deaths in the United States, Bjerklund Johansen noted.
The Zeroes Speak for Themselves
Prostate cancer experts hailed the new findings.
“I think the zeroes speak for themselves,” said Jeremy Grummet, MD, a urologic surgeon at Monash University, in Melbourne, Australia. “These data are all in line with the literature. Transrectal biopsy is untenable and should be stopped.”
Many centers now offer transperineal biopsy under local anesthesia, “so clinicians can’t blame a need for general anesthesia,” Grummet added.
Richard Szabo, MD, a urologist at the Southern California Permanente Medical Group in Orange County, who has published on biopsy issues, said that not only is transperineal biopsy safer than the transrectal approach, as the new data and other studies demonstrate, the method is more accurate when coupled with MRI/ultrasound fusion targeting, too. “It’s thought that this increased accuracy is largely due to better sampling of the anterior prostate and more efficient sampling of the peripheral zone,” Szabo said.
“Given the increased safety and accuracy reported in the literature, more and more patients are demanding a transperineal biopsy instead of a transrectal biopsy. The American Urological Association guidelines on prostate biopsy are presently being revised and may soon join with the EUA in recommending the transperineal over transrectal approach,” he added.
Bjerklund Johansen said it is important for all urologists to disclose complications and infections to patients when proposing biopsies or other procedures. He said these numbers have swayed Norwegian patients to switch to doctors who perform transperineal biopsies.
Policies are changing.
The Norwegian System of Patient Injury Compensation, a public agency that handles malpractice claims, regarded Roar Gulbrandsen’s death to be a complication of transrectal biopsy and compensated his family. Agnes Gulbrandsen said she received about $12,000, which covered funeral expenses.
The EAU in 2021 recommended that urologists switch to transperineal biopsies from transrectal biopsies. Hein Van Poppel, MD, policy chief for the association, told Medscape that transrectal biopsies are considered “medical malpractice” in Europe.
In 2022, the Norwegian Health Directorate ordered urologists in the country to stop performing transrectal biopsies. At Oslo University Hospital, physicians and nurses are now undergoing obligatory training in diagnosing and treating sepsis, according to Bjerklund Johansen.
Szabo said transperineal biopsies not only avoid infections but also demonstrate a significant increase in accuracy in the diagnosis of prostate cancer when coupled with MRI/ultrasound fusion targeting.
“It’s thought that this increased accuracy is largely due to better sampling of the anterior prostate and more efficient sampling of the peripheral zone,” he said. “Given the increased safety and accuracy reported in the literature, more and more patients are demanding a transperineal biopsy instead of a transrectal biopsy.”
Another advantage of transperineal biopsies that clinicians often miss, Grummet added, is that it does not require “big gun prophylactic antibiotics, as there is for TR biopsy. In fact, many of us are using no antibiotics at all because it is so easy to sterilize the perineal skin.”
US Lagging
The American Urological Association has not made a push for adoption of transperineal biopsies in the United States. Some American urologists are being retrained in transperineal methods.
Many urologists have resisted change because the shift requires roughly $40,000 for equipment, as well as time off for retraining, according to urologist Matthew Allaway, DO, founder and CEO of Perineologic, a transperineal system maker based in Cumberland, Maryland. Allaway said urologists also have resisted switching until insurers boost reimbursement for transperineal procedures, which require a few more minutes to perform than the transrectal method.
Only about 10% of biopsies in the United States are performed transperineally, Allaway said. An AUA spokesperson said new guidelines on biopsies will be presented at its annual meeting in Chicago in late April.
The sources in this story have disclosed no relevant financial relationships.
European Association of Urology (EAU) 2023 Annual Meeting. Presented March 11, 2023.
Howard Wolinsky is a Chicago-based medical freelancer and a patient diagnosed with low-risk prostate cancer who has been on active surveillance since 2010. He is the editor of the Substack newsletter, TheActiveSurveillor.com.
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