Encouraging news for prostate cancer and a better way to biopsy
After 15 years, prostate cancer–specific mortality was low regardless of the treatment assigned…
For the 1610 patients with localized prostate cancer who were followed for death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy in this study, it made little difference whether they had active monitoring, surgery, or radiotherapy.
A study recently published in The New England Journal of Medicine offers reassuring data for men with localized prostate cancer. The authors followed 1643 patients to evaluate the comparative effectiveness of treatments. 545 were randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to undergo radiotherapy.
The authors state:
“At a median follow-up of 15 years (range, 11 to 21), we compared the results in this population with respect to death from prostate cancer (the primary outcome) and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy (secondary outcomes).”
Low prostate cancer–specific mortality regardless
Even though a third of the subjects had intermediate or high-risk disease at diagnosis, the great majority did well:
“Follow-up was complete for 1610 patients (98%). A risk-stratification analysis showed that more than one third of the men had intermediate or high-risk disease at diagnosis. Death from prostate cancer occurred in 45 men (2.7%): 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (P=0.53 for the overall comparison). Death from any cause occurred in 356 men (21.7%), with similar numbers in all three groups. Metastases developed in 51 men (9.4%) in the active-monitoring group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group. Long-term androgen-deprivation therapy was initiated in 69 men (12.7%), 40 (7.2%), and 42 (7.7%), respectively; clinical progression occurred in 141 men (25.9%), 58 (10.5%), and 60 (11.0%), respectively. In the active-monitoring group, 133 men (24.4%) were alive without any prostate cancer treatment at the end of follow-up. No differential effects on cancer-specific mortality were noted in relation to the baseline PSA level, tumor stage or grade, or risk-stratification score. No treatment complications were reported after the 10-year analysis.”
Quoted in Medscape, the authors, led by Freddie C. Hamdy, MD, from Oxford University the United Kingdom state:
“Radical treatments (prostatectomy or radiotherapy) reduced the incidence of metastasis, local progression, and long-term androgen-deprivation therapy by half as compared with active monitoring. However, these reductions did not translate into differences in mortality at 15 years, a finding that emphasizes the long natural history of this disease.”
Medscape also quotes Peter Albers, MD, a urologist at Düsseldorf University in Germany and chair of the EAU's Scientific Congress Office:
“The fact that the greater progression of disease seen under active monitoring didn't translate into higher mortality will be both surprising and encouraging to urologists and patients…Active monitoring and biopsy protocols today are much more advanced than at the time this trial was conducted, so it's possible we could improve on these outcomes still further. It's an important message for patients that delaying treatment is safe, especially as that means delaying side effects as well.”
Naturally, each case should be managed on an individual basis with a comprehensive evaluation of the risk factors and the biological landscape unique to each patient. The authors of the study conclude:
“After 15 years of follow-up, prostate cancer–specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer.”
A safer and more effective way to biopsy the prostate
If a biopsy is necessary, it’s time to demand a transperineal instead of a transrectal biopsy.
The Annual EAU (European Association of Urology) Congress is Europe’s biggest urological event and presents the latest in science and education in various formats. The comprehensive program of the 38th Annual EAU Congress that took place in March included an importance advance in prostate biopsy that was spearheaded by the committed daughter of a Norwegian stonemason and the Norwegian Health Directorate. As reported in Medscape:
“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.”
They quote Truls Bjerklund Johansen, MD, who'd performed the biopsy on Gulbrandsen and worked with the man's daughter to change national practice:
“We have shown that switching to transperineal biopsies can bring deaths and infection rates to zero.”
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 to zero, and the national rate of severe infections, including sepsis dropped to 0.5%. And in Olso County where transrectal biopsies had been phased out earlier, there were zero cases of infections and deaths.
Medscape also quotes Jeremy Grummet, MD, a urologic surgeon at Monash University, in Melbourne, Australia:
“I think the zeroes speak for themselves. These data are all in line with the literature…[And] 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. 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.”
More accurate too
Medscape also quotes Richard Szabo, MD, a urologist at the Southern California Permanente Medical Group in Orange County, who has published on biopsy issues:
“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."
The U.S. is lagging behind
Medscape notes that in the European Union:
“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.”
How could it be more blatantly obvious that passing a needle into the prostate through a clean perineum is preferable to a needle that’s gone through the rectum teeming with bacteria?
But in the U.S., only about 10% of biopsies in the United States are performed transperineally. Though some American urologists are being retrained in transperineal methods, the American Urological Association has not made a push for adoption of transperineal biopsies in the United States.
Urologist Matthew Allaway, DO, founder and CEO of Perineologic, a transperineal system maker in Maryland, stated to Medscape that there are costs of equipment and time off for retraining; and that “urologists also have resisted switching until insurers boost reimbursement for transperineal procedures, which require a few more minutes to perform than the transrectal method.”
