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TREXIT


CHICAGO — While the UK struggles with its Brexit from the European Union, another kind of leave-taking is underway — and on time so far — in the nation's urology community.

"Trexit" is a "complete and clean break" from transrectal prostate biopsy in favor of transperineal (TP) approaches for diagnosing or monitoring prostate cancer, write British physicians in an abstract presented here at the American Urological Association (AUA) 2019 Annual Meeting.

The biopsy initiative is serious stuff, but the Trexit innovators could not resist being cheeky about their country's geopolitical limbo, suggested lead author Luke Stroman, MD, Guy's Hospital, London, UK, where the campaign started.

"Yes, 'clean break' is a play on the fecal matter of the transrectal approach but also on the phrase politicians have been using that Britain should have a clean break from the EU," he told Medscape Medical News.

Stroman explained that passing biopsy needles through the rectal wall on the way to extract tissue from the adjacent prostate gland carries the risk of triggering sepsis.

Sepsis risk is much lower with TP approaches, which are performed percutaneously, but logistical issues have limited uptake by urologists, he said.

So the London team performed a feasibility study of a TP-only biopsy strategy among 678 consecutive men with suspected (78%) or actual prostate cancer (22%) at Guy's. No men underwent transrectal ultrasound (TRUS) guided biopsy.

The TP-only biopsy strategy, which was facilitated by the novel PrecisionPoint Transperineal Access System (Perineologic), was indeed feasible, Stroman reported at the meeting. TP biopsy provided low complication rates, including 0.16% for sepsis (that required hospital admission and intravenous antibiotics).

Also, urologists in the study carried out 58% of TP biopsies under local anesthesia, which enables an in-office procedure and would be a boon to wider adoption of the method.

Step one of Trexit was this feasibility study, which started as planned at Guy's on September 1, 2017. The hospital has not performed a TRUS biopsy since that day.

Step two was to implement the TP change in nearby hospitals and the entire Southeast London Cancer Network before March 7, 2019, a couple of weeks ahead of the now passed Brexit deadline.

Mission accomplished, said Stroman. "We challenged ourselves to beat the time of Brexit and we did," he said.

Step three of the Trexit project is to enact the switch at various — and then all — centers throughout the UK, which hopes to be the first country to fully retire TRUS biopsies. There is no target completion date at this time, but the effort is supported by a National Health Service innovation program.

However, Jan Philipp Radtke, MD, University Hospital Essen, Germany, told Medscape Medical News that the biopsy-method switch is not novel.


Multiple European medical centers have made the switch — some as long as 8 years ago, he said. The reported complication rates with TP biopsies are near zero. "They are very, very good," said Radtke, who comoderated the podium session that included the Trexit presentation.

In the United States, the PrecisionPoint system used in the new UK study has been FDA approved since 2016 and is in use at American centers, including Johns Hopkins in Baltimore, Maryland, MD Anderson in Houston, Texas, and Rush University in Chicago, Illinois, according to the company website.

Developed by urologist Matthew Allaway, MD, Cumberland, Maryland, the system does not require extensive training, said Stroman. "The learning curve has been quick," he said. After assisting on 14 cases, he went "solo," Stroman told the AUA audience.

Michael Gorin, MD, of Johns Hopkins, provided a casual but similar assessment in a 2017 tweet (@michael_gorin): "...In-office perineal bx with PrecisionPoint is easy peasy!"

The term Trexit is not currently being used outside the UK, said Stroman. It was coined by Tim O'Brien, MD, the incoming president of the British Association of Urologic Surgeons.

#Trexit also has a presence on social media, including Twitter, and coincidentally shares the same hashtag with calls for the impeachment of US President Donald Trump.


The AUA presentation also included some mention of politics, a rare event at a scientific congress. The session moderator, an American, had fun with British presenter Stroman.

"I notice Teresa May is not a coauthor on this," quipped Kevin Loughlin, MD, Harvard Medical School, Boston, Massachusetts, immediately after Stroman ended his talk, triggering audience laughs.

Device, Local Anesthesia Are Key
Historically, TRUS has been used to perform prostate biopsies, a process aided by the use of local anesthesia. It is still the most commonly used method.

TP biopsies, on the other hand, have required general or spinal anesthesia to allow patients to tolerate multiple needle passes through the perineal tissue.

However, in the new study, the novel PrecisionPoint tool allowed for local anesthesia, including in the office setting, by reducing the number of needle passes. The TP device was used with or without MRI fusion technology.

The Guy's Hospital team also used a single preoperative dose of antibiotics for each procedure. However, routine clinical use of the PrecisionPoint system would not require such prophylaxis, they say. The median age of men in the study was 60.5 years.

One of the 678 patients (0.16%) had sepsis requiring hospital admission and intravenous antibiotics, and the same numbers were reported for UTI and hematuria with clot retention. A total of four patients (0.5%) had urinary retention. No patients with retention needed surgery. Vasovagal episodes occurred in seven (1%) patients, although six of 395 (1.5%) of these were following local anesthesia. No complications were classified as Clavien 3 or higher.

Local anesthetic was used for the biopsy in 395 patients (58%), of whom 168 (42%) underwent the procedure in the outpatient clinic.

Biopsy under general anesthesia was completed in 205 patients (30%) and under IVS in 78 patients (11%). Systematic biopsies and systematic biopsies with additional targets were both completed in about 40% of the patients. And limited targeted biopsies were done in only 19%.

US researchers are also looking at the two approaches to prostate biopsy. In a feasibility study presented as a poster at the meeting, Alexa Meyer, MD, and colleagues from Johns Hopkins University, are evaluating TP (with the Precisionpoint system) and TRUS biopsies in an ongoing prospective cohort study. Early data from the study suggest cancer detection rates of the two approaches are the same, they report.

The authors and moderators have reported no relevant financial relationships.

American Urological Association 2019 Annual Meeting. Presented May 6, 2019. Abstract PD64-03