(Editor’s note. I have beating the drums on transperineal biopsies being named the top biopsy to prevent avoidable deaths by biopsy. A Norwegian researcher estimates that 3,000 men globally, including 2,000 in the U.S., die from sepsis caused by prostate biopsies. Doctors internationally have mobilized to stop transrectail bopsies. A couple of new studies have been published, but researchers have reached an impasse because the findings conflict. I suspect the debate will drag on while more men will die. So I suggest that patients support groups and concerned physicians take matters into their own hands and vote with their biopsy choices. Sign my petition: https://chng.it/skqzPrHrsNThat’s the short version. Here’s the long version. HW)
By Howard Wolinsky
Since the American Urological Association adopted its guidelines taking a neutral stand on transrectal (TR) prostate biopsies 2023, an estimated 2,000 men have died sepsis caused by a prostate biopsy.
I’ve said it before, and I’ll say it again: Men need not die from prostate biopsies.
I know some, maybe many, urologists don’t believe it and are skeptical that switching to transperineal (TP)l biopsies, which entail pushing the needles through the sterile perineum, the area between the testicles and the anus, will make a difference. TRs push needles through the germy rectum, which critics see as the source of sepsis..
In 2023, as a consumer reviewer, representing myself and the AnCan Foundation’s Virtual Support Group for Active Surveillance, I told the AUA that they were ignoring a blaze engulfing the house (of prostate biopsies), and it was high time for American urologists to call the fire department. I urged the AUA to follow the example of the European Association of Urologists, which in 2021 made TP biopsy the preferred approach, doctors in the Norway, United Kingdom, Netherlands, Australia and other countries dropped TR biopsies.
EAU focused on the risks of sepsis, which can kill, cause strokes, and lead to loss of limbs, and encourage better management of the use of antibiotics to prevent a rise in antibiotic resistance. I laid out the debatein Medscape.
Daniel Lin, MD, vice chair of the AUA panel, told me the AUA required strong evidence--level A1--in its guidelines to justify a major change in its guidelines to justify altering the standard of practice. They wanted to weigh the results of randomized studies, the champagne of research, before adopting a dramatic change.
Fortunately, such studies were in the works. That was the good news.
Two studies have now come out in highly respected journals from top researchers. And, frankly, from this patient’s point-of-view, we’re no better off than we were before.
Bidan Mian, MD, professor of surgery at Albany Medical College, principal investigator of the ProBE-PC study, the firstsingle-center randomized trial on TP vs.TR with 763 patients, said, his study found no difference in infectious or noninfectious complications between transperineal and transrectal biopsies.
His study in the Journal of Urology concluded in February: “Among men undergoing transperineal or transrectal prostate biopsy, we could not demonstrate any difference in the infectious or noninfectious complications. Both biopsy approaches remain clinically viable and safe.”
Then, Thursday, lead author Jim Hu, MD, MPH,urologic oncologist at NewYork-Presbyterian and Weill Cornell Medicine, and senior author, Edward “Ted” Schaeffer, MD, PhD, chairman of urology at Northwestern University in Chicago, came out with firstmulticenter randomized comparison of TR and TP in JAMA Oncology. They found an advantage to TP over TR.
The PREVENT Randomized Clinical Trial involved a similar number of patients (742) and came to a different conclusion.
A “Who’s Who” of researchers from 10 centers were involved, coming from New York Presbyterian Weill Cornell Medicine Hospital,l Northwestern, Memorial Sloan Kettering Cancer Center, UConn, Health Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, MedStar Georgetown University Hospital, Michigan Medicine (University of Michigan), University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine in Cleveland, Ohio, and Icahn School of Medicine at Mount Sinai, New York.
As I put it my article in Medscape Thursday: TP and TR “are in a dead heat for diagnosing prostate cancer, but none of the participants who received TP developed infections while 1.6% of the TR group did. The TP method involves passing a needle through the perineum.”
Hu told me: “This study is significant because the transrectal biopsy approach requires preventative antibiotics and an enema to be given beforehand, and even with these precautions, infectionsoccur in up to 5-7% of transrectal prostate biopsy, based on retrospective data. We examined patient outcomes after first-time prostate biopsy, and we demonstrated no infections after transperineal biopsy and 1.6% after transrectal biopsy with targeted prophylaxis.”
"Our study shows a very low 0% infection risk, without the need for preventative antibiotics, which can potentially save lives," he said.
(A few weeks ago, I noted this lstudy was coming.)
Hu told me he thinks his study merits revisiting biopsy guidelines.
A spokeswoman said NCCN had no comment. (Schaeffer, senior author of the Hu study, is chairman of NCCN’s prostate cancer panel.) An AUA spokeswoman said its guidelines are scheduled for review in 2025 and will be amended if sufficient evidence exists.
Will this issue drag on?
I suspect that this issue will drag this on and there will be a call for further research--while the fire keeps burning, and men--unnecessarily--keep dying. The heat from this fire is undermining the structure of the house of biopsies.
Hu and Bian disagree on whether the new study is last word based on randomized research.
Hu said: “Do I consider our study a definitive one? Yes, (it is) the first to demonstrate a significant difference in favor of transperineal biopsy, but on top of that, it is performed without preventative antibiotics as compared to the targeted antibiotics used in the [transrectal] group”
He noted that the JAMA Oncology study only covers patients undergoing first-time biopsies.
His group also is conducting a randomized trial in patients who are undergoing subsequent biopsies. “The second study is for patients on active surveillance and with prior negative biopsy. Retrospective data suggested that men undergoing repeat biopsy are at increased risk of infection. The second study has the same study design and together, these randomized trials will be the only multicenter studies with infection as the primary outcome.”
Some critics believe organized urology is deliberately delaying implementation of a pro-TP policy in the financial interests of its members, who would have to spend $40k to set up TP in their practice and take time to be trained in the technique. Medicare pays the same in physician fees for performing TR and TP, which takes more time and generates more costs, including general anesthesia in about half the cases.
Common sense
Truls Erik Bjerklund Johansen, MD, professor emeritus of urology at the University of Oslo, Norway and emeritus consultant urologist at the Urology Department, Oslo University Hospital in Norway, was the lead figure in uncovering the risks from transrectal biopsies after proving one of his patients died from the urosepsis from a TR biopsy His work led EAU to favor TP over TR.
Johansen had performed. He presented his case to AUA, where he said he encountered disbelief, skepticism and cold shoulders.
But he stands by his estimate that 2,000 American men a year die from TR out of 2 million who undergo the procedure. “1/1000 patients undergoing TR biopsy will die from procedure-related complications, mainly urosepsis,” he told me.
Johansen said the issue isn’t as complicated as the guideline groups make it out to be.“European urologists realized they had a choice between a clean and a dirty method and chose the clean method. They also realized that antimicrobial resistance has become the greatest health threat to all. The best means to avoid resistance is to reduce unnecessary use of broad-spectrum antibiotics. You don`t need RCTs (randomized controlled studies) to realize this. Common sense and knowledge about (Dr. Ignaz) Semmelweis and the (2016 O`Neill) Review of Antimicrobial Resistance are enough.”
American urologists think they would know if their patients had died from sepsis. IBut that isn’t necessarily so. These deaths can emerge a month or more after the biopsies. So urologists may not know when a patient doesn’t show up for an annual exam that he died from sepsis caused by a biopsy.
The Norwegian patient’s daughter had urged an investigation be done, which became front-page news in Norway and led to men demanding TPs and eventually the policy change at EAU. I began campaiging on this in 2021 in articles and a petition calling for TR to be retired in the interest of patient safety. (IPlease sign petition (https://chng.it/skqzPrHrsN) if you agree we need to dump TR and save lives. Also, don’t make any donations to Citizen.org.) Urologist Hendrick Van Poppel, MD, policy chair of the EAU, told me that TR biopsies are tantamount to “medical malpractice” in Europe.
There also has been a big public outcry against transrectal biopsies in Australia, which led the government health plan, Medicare, to double fees for urologists who performed TP to encourage change. TRexit, an international group of physicians, has been calling for TR to go the way of the Tasmanian tiger.
American patients and urologists seem to have high tolerance of another public health disaster impacting us.
Rare TP biopsies
Unfortunately, TPs can be hard to come by in the U.S.
And it should be noted that they’re not perfect. Some patients complain about pain from TPs, and also, as the National Comprehensive Cancer Network, a leading guideline-writing organization for prostate cancer, there is increased risk for urinary retention.
But still, as the spouse of a patient who drove 1,400 miles to undergo a TP because none was available near home, put it, “What’s worse? Some momentary pain, or dying from sepsis caused by a transrectal biopsy?”
Richard Szabo, MD, a biopsy researcher and clinical clinical professor of urology at the University of California Irvine, said urologists should wake up: “The virtual absence of post-transperineal biopsy sepsis in retrospective studies should be a guide to clinicians wishing to spare their patients this dangerous complication.”
Danny Vesprini, MD, a radiation oncologist and head of Active Surveillance at Sunnybrook Health Sciences Centre at the University of Toronto, told a webinar I attended in 2022, “There should be no transrectal biopsies” because of the risk for sepsis.
Transperinal rate up, but small
The national rate for transperineal biopsies in the U.S is roughly 10%, up from 5% two years ago, according to urologist Matthew Allaway, DO, founder of Perineologic, developer of an updated, less-invasive system of transperineal known as PrecisionPoint. Doubling sounds like a big deal. But the numbers are so small.
Allaway is biased of course, but he believes Hu and Schaeffer’s multi’center study “trumps” Mian’s single center randomized trial.
TP rates among the educated readers of TheActiveSurveillor.com are a far different story than in the prostate cancer community at large.
I found in a small survey that about one-third of respondents had had a transperineal biopsy—more than three times higher than the general public—while 49% said their next biopsy will be transperineal vs. 10% who said it would be a transrectal. The rest were unsure.
What to do about biopsies? It’s in our hands
Hu said, “If TP is preferred, patients should seek out experienced physicians to provide the best outcomes. If patients do not find experienced urologists to perform transperineal biopsy, they should request targeted prophylaxis for transrectal biopsy.”
He noted that professional guidelines are “fundamentally recommendations of best practice. Our hope is that our findings will also be disseminated to patients themselves so they are armed with knowledge for advocacy.”
Vesprini suggested that patients who want transperineal biopsies tell their TP-resistant doctors: ‘I'm going to take my business elsewhere’ … I mean, it's a business.”
Szabo said: “I think honestly the way to get the needle to move is through influencing the laypeople. It's just -- things are popping up logarithmically. I'm just getting way more demand for the transperineal. People are just refusing transrectal more and more. It's still -- unfortunately a minority of American urologists who are really offering it.”
Time for patient action on TP to protect their lives.
It’s time for American patients to rise up as did those in Norway: Vote with your feet—and your prostate.
I also think this is also time for patient advocacy groups to take a stand on behalf of their constituents.
AnCan, the patient support platform, has led on this issue. Rick Davis, AnCan founder, told me that The Active Surveillor and I are “AnCan's official spokesperson on TP vs TR.” This makes it tricky for tricky navigation forra journalist (in Medscape, where I play it straight) vs. now when I am writing a commentary and am a spokesman for patients and an advocacy group.
Davis said, "AnCan has endorsed Howard Wolinsky and The Active Surveillor since the onset of his patient-centric campaign to have the AUA adopt transperineal biopsies as the standard procedure. Not only are TPs safer, but make ithey make it easier to identify anterior and occult lesions. AnCan has seen this make a difference to our participants, especially men with small amounts of hidden Gleason 4. Transperineal saves lives from more than just infections."
What to do? Look out after your safety. Watch this debate on TR vs. TP:
Sign my petition. Write to Medicare. Talk to your Congressional rep. Discuss the pros and cons of TR vs. TP with other patientsat support groups..Important: Ask your doctor what his/her prostate biopsy infection rate is and his/her stand on/experience with TP vs. TR. Don’t be surprised if you have to look for a new doctor,
Act like your life depends on it—because it actually does.
Still time to sign up for Sept. 28 ASPI webinar with Dr. Peter Carroll, AS pioneer
Peter Carroll, MD, MPH, of the University of California, San Francisco, one of the pioneers of Active Surveillance for low-risk prostate cancer, in the late 1990s, will be speaking to Active Surveillance Patients International at noon Eastern on Saturday Sept. 28, 2024.
His program is entitled “Active surveillance for prostate cancer – the past, the present, and the future.”
Carroll is the 2024 recipient of Active Surveillance Patients International’s Chodak Award honoring pioneers in the development of the Active Surveillance approach to managing lower-risk prostate cancer. The award is named for the late Gerald Chodak, MD, of the University of Chicago, he laid down the fundamentals for a more conservative approach to managing these patients. Chodak was ASPI’s first medical advisor.
Watch ASPI’s award presentation to Carroll, Mike Scott, of Prostate Cancer International, and Drs. Freddie Hamdy and Jenny Donovan, of the ProtecT Trial, at https://aspatients.org/awards/
The Active Surveillor is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.
Because healthcare is financially driven it's plagued with exaggerations and misrepresentations.
In fact, most everything in the prostate cancer arena is a falsehood because physicians have become disconnected from science. Virtually none of the current recommendations for prostate cancer can withstand the most basic of challenges - where is the irrefutable and reproducible evidence supporting the safety and benefits of that recommendation? Little wonder, only about 11% of medical treatments are of known benefit.
0 TP infections without antibiotic prophylaxis vs 1.6% TR infections with targeted prophylaxis (p=0.02). No difference in cancer detection 55% vs 52% for TP vs TR.
Wei Phin Tan, MD, MHS
@DrTanWP
·
1h
Exactly. Everyone should be switching to TP only.
@michaelabern
has shown a 10x higher risk of sepsis complications with FQ-resistant rectal flora, even when using targeted antibiotics.
Brian F. Chapin
@ChapinMD
Disagree. Lots to consider and these trials all show minimal difference. Logistics of TP can outweigh ease of TR in specific circumstances. First publication showed no diff, now with 1 more infection the world has changed? I would support TR and defend it every time.
(Urologist in Melbourne here). This train left the station many years ago in Australia, and no way patients would accept TR biopsy here nowadays. In fact, it was patient advocacy that led to the Government increasing the reimbursement for TP biopsy a few years ago (and decreasing the funding for TR). Now, here in Victoria (where Melbourne is, about 7m people), more than 95% of all prostate biopsies are TP. In my centre (Peter MacCallum Cancer Centre), I banned TR biopsy in 2010 when I took over here. I personally last did a TR biopsy in 2007. None of our urology trainees have ever seen a TR biopsy.
My argument (trials notwithstanding) - why put the needle through the poo when we can put it through the skin?? It's nuts. Just because it's convenient (for urologists), is not a good reason. Plus we need to preserve antibiotics as they won't be with us forever.
Check out our podcast (search GU Cast) for episodes discussing this.
A Washington State reader responded to my commentary with a Vive la resistance!
He said: Hear, hear.
Dan Lin told me why not TP when I asked. Paraphrasing: too expensive to retool. (I'm guessing—also a pain to retrain.) Paraphrasing: infection rate just fine (implicitly because of antibiotics).
Still no biopsy for me. High PSA, but I learned about PSA density. I have a very large prostate. MRI I insisted on showed only a tiny equivocal lesion. (My radiologist) said good decision not to get a biopsy.
Dragged my heels on getting an ablation for urinary problems. Hard to find someone to do aquablation instead of a knife job. Problems abated despite not being ablated. Glad I waited.
Vive la resistance!
He aded this:
He asked Daniel Lin, MD, his former urologist, about TR vs. TP.
He said Lin, who is tops in the field, told him: (1) Urology departments have limited budgets and there are competing demands for resources; (2) UW infection rates are very low. Implicitly, therefore 1+2 = no compelling need to redirect expenditures toward new devices and idling perfectly adequate equipment or use new funds for the change.
Dale Bryant, a patient advocate, a Wisconsin transplant to British Columbia, is a good friend even though he is a Green Bay Packer fan. Go Bears. Dale is a leader in the Tri-Cities Prostate Cancer Group: https://www.tricitiesprostate.com/ He has set me straight at times when I needed it.
But he agrees that something has to be done by organized urology about the risks posed by transrectal biopsies. Worldwide, 3,000 men die per year rom transrectal biopsies, according to a leading Norwegian researcher. Good to have Dale in the foxhole.
The prospect of annual transrectal biopsies--which were common until a few years ago--were among the reasons he underwent a radical prostatectomy.
Here's more of what he says:
Hi Howard
Great article about transperineal biopsies, one of my personal issues that really disturbs me about the state of urology and Prostate Cancer. What seems like such a small percentage who suffer sepsis through transrectal biopsies gets magnified by every one of these damn things a guy has to have done. This was one of the factors that weighed into my decision for a radical prostatectomy 6 + years ago. I did not like the odds of staying on AS and having to have almost annual biopsies. After 5 years of annual biopsies (or almost annual biopsies), one's odds of contracting sepsis in the process approach or exceed 10%. I did not like those odds at all. With transperineals, the odds are basically nil of contracting sepsis, and with a much better level of accuracy given the hard to reach places they can get to in a prostate as opposed to transrectals.
Your following segment truly captures the reality of why doctors have not abandoned transrectals altogether:. Separate from the cost of buying the equipment, I think the real reason is that they don't want to take time away from their practice to learn a new trick, even one that will save lives. Kind of sad commentary on people we put a lot of trust in!
Some critics believe organized urology is deliberately delaying implementation of a pro-TP policy in the financial interests of its members, who would have to spend $40k to set up TP in their practice and take time to be trained in the technique. Medicare pays the same in physician fees for performing TR and TP, which takes more time and generates more costs, including general anesthesia in about half the cases.
Thanks for keeping up this important fight, Howard.
A couple weeks ago Bill Manning, the new executive director of Active Surveillance Patients International, and I led a support group for men with low-grade prostate cancer on active surveillance.
Two guys spoke up AGAINST transperineal biopsies. They said the pain was excruciating.
I pointed out they could have gone under anesthesia and also that some men find the pain is temporary. Also, again, the best estimates are that 2,000 U.S. men/year DIE from sepsis. Death from a biopsy aimed at finding a cancer that in many cases is no danger,
My good friend Jim Goodacre, another veteran AS patient, recalled this meeting in the following note:
Hi Howard: Remember in our seminar we had at the PCRI meeting in L.A. You were the moderator and one of the guys in the audience said that the TP Biopsy, he had was really painful and if he had his choice to do another one, he would do a TR Biopsy the next time.
Damn--too bad the TP Biopsy is a lot more painful. It is painful for the TR Biopsy I can't imagine more pain than that.
I am no stranger to handing pain since I have had 14 kidney stones. An interesting fact to find out is the men who died because of sepsis was it their first biopsy or was it a repeat biopsy.
I wonder if you can handle a TR biopsy without infection then what is the odds you will have a problem with the repeat biopsies.
I have never heard why the men who got sepsis got it to begin with? Why didn't the antibiotics work on the men who died? If antibiotics work on 98% of the men what is the reason it didn't work on the 2% of the men? Is there a test to determine if antibiotics will work on you before you take the antibiotics? Inquiring minds wants to know?
Well, Jim, it is possible screen men with rectal swabs to see if they have antibiotic-resistant bacteria. If they do, special steps can be taken to provide IV antibiotics.
As Dr. Hu said,if you don't TPs available in your community, amnd many don't, this techique can make this TR biopsy safer.
This happened to me eight years ago. I had diverticulitis and taken heavy-dose antibiotics, which made me vulnerable to sepsis and other infections. So I had IV antibiotics. as a prep along with an enema and an antibiotic chaser, I came out fine.
A TP would have done the trick. And my urologist now does them.
Let's Move the Needle and save lives. Happy to hear from Dr. Jeremy Grummet, a long-time advocate for transperinal and a leader in the TRexit movement from Australia. With his permission, I reprint his note:
Hi Howard,
Thank you for your advocacy on this.
Prostate biopsy is not a sexy topic, but is arguably one of the most important topics in prostate cancer, given the sheer volume of these procedures done globally.
It was 2017 when I gave my Moving the Needle talk at the AUA plenary in Boston, debating the prominent Dr Ben Davies.
Ben has since converted to TP biopsy. (He would be a great person to talk to about this.)
Dr Hu’s RCT shows what we have seen in practice for well over a decade.
The most telling point of their RCT is the lack of sepsis in TP biopsy without ANY antibiotics.
Try doing a TRUS biopsy without any antibiotics and you’ll eventually end up with a dead patient.
So now the only way to do a “safe” TRUS biopsy is by giving “targeted prophylaxis” which means taking a rectal sample and seeing what bugs are living there. But this is far from foolproof as well, as there are numerous different flora residing in the rectum, and some can be missed on sampling.
The obvious question then is, why not avoid the rectum ENTIRELY, which is what a TP biopsy does, and you can forget about rectal flora and antibiotics? You can also forget about adding to the development of superbugs, which is what unnecessary use of antibiotics inevitably leads to.
It’s a no-brainer and has been for years.
Having watched the inertia on this in the US for years now, while the rest of the world has moved on, the cynical part of me wonders if the lack of guideline change there is due for reasons more financial/political than medical…
Feel free to use any of the above publicly.
Cheers
Jeremy
A/Prof Jeremy Grummet
MBBS MS FRACS
Urologic Surgeon and Prostate Cancer Specialist
Director of Urology
Alfred Health, Monash University
Former EAU Guidelines Prostate Cancer Panel Member
Dr. Hu tells me one more positive randomized trial will do the trick.
But I think we patients need to vote with our feet and prostates--avoid transrectals. If you are worried about pain, consider general anesthesia. At the very least, if you have no choice but transrectal, ask that you be screened for nasty bacteria and ask for antibiotics. Time to rise up.
Howard, another home run. So many in the USA are totally unaware of Trans perineal biopsy. The AUA needs to update the guidelines and urologists have to be trained in the procedure.
Jim, Thanks foir your comments. I don't understand why organized urilogy doesn't take this seriously, If Dr. Johanson is right, 2,000 US men and 1,000 others internationally are dying annually. How can urology just shrug its shoulders collectively and say 'Oh, well.' US men, especially, need to protect themselves and ask questions and take action.
that the trans-rectal prostate biopsy is licensed medical malpractice is old news. My urological colleague Anthony Horan MD underscored the dangers and lack of science surrounding the trans-rectal prostate biopsy in his book The Big Scare, published in 2009 and in his revised edition, The Rise and Fall of the Prostate Cancer Scam, in 2019. Anthony detailed the deaths from sepsis after trans-rectal biopsies and the fact that death certificates are unreliable. Everyone, including urologists, need to read these books.
In summary;
> how urologists are OK with the passage of a needle through a dirty rectum is beyond comprehension
> how urologists are OK with a 12-core sample size that biopsies randomly and blindly about 0.1% of the prostate is beyond comprehension - especially when prostate cancers tend to be multifocal
> both the trans-rectal and trans-perineal biopsy techniques are associated with gross sampling errors since only 0.1% of the prostate is sampled
> understanding the multifocal nature of prostate cancer and the incredibly small biopsy sample size makes a mockery of the upgrading and progression phenomena - these cancers were simply missed by the initial 0.1% sampling
> how these biopsy techniques can be deemed standard-of-care by physicians is beyond comprehension
> how these biopsies can be recommended in their AUA guidelines for prostate cancer is also beyond comprehension
Finally, and here’s the kicker;
> PSA testing/screening fails to save significant numbers lives
> treatments fail to save significant numbers of lives - at 15 years NO treatment had similar survival rates as surgery or radiation but without all of the complications routinely associated with treatment - the links to all these articles are in the blogs you published.
We have a doctor-created epidemic of overdiagnosis and overtreatment.
Dr. Johanson, based on his research in Norway, estimates that 2,000 men a year are dying in the US and 1,000 more in other countries from sepsis caused by transperineal biopsies.
Sadly, a major reason for the many angles is that the business of prostate cancer is ruled mostly by opinions, exaggerations and misrepresentations. The current recommendations for prostate cancer testing and treatment have only unleashed an embarrassing public health disaster. A catastrophe that could be corrected if physicians would support their recommendations with irrefutable and reproducible data.
The AUA demand for guidance by randomly-controlled trials is bullshit. If the AUA cared to gather evidence, there is now a sufficient proportion of TP biopsies that simply obtaining data on patient hospitalization and death after all biopsies would settle the question with only a few months of data. If the data are anonymized, they could be gathered from practices and their associated hospitals as an epidemiological research project.
Suggestion: Get in touch with Dr. Harvey Risch of Yale University. He is a top tier medical epidemiologist who showed great good sense during the Covid events. Dr. Risch might be willing to advise how to proceed with an epidemiological research approach to the TR vs TP question.
Because healthcare is financially driven it's plagued with exaggerations and misrepresentations.
In fact, most everything in the prostate cancer arena is a falsehood because physicians have become disconnected from science. Virtually none of the current recommendations for prostate cancer can withstand the most basic of challenges - where is the irrefutable and reproducible evidence supporting the safety and benefits of that recommendation? Little wonder, only about 11% of medical treatments are of known benefit.
So the debate starts again: https://x.com/ChapinMD/status/1838034659852140706
Jim Hu
@jimhumd
·
Sep 19
Final results of
@theNCI
RCT of Transperineal vs Transrectal Prostate Biopsy
From jamanetwork.com
Jim Hu
@jimhumd
·
Sep 19
0 TP infections without antibiotic prophylaxis vs 1.6% TR infections with targeted prophylaxis (p=0.02). No difference in cancer detection 55% vs 52% for TP vs TR.
Wei Phin Tan, MD, MHS
@DrTanWP
·
1h
Exactly. Everyone should be switching to TP only.
@michaelabern
has shown a 10x higher risk of sepsis complications with FQ-resistant rectal flora, even when using targeted antibiotics.
Brian F. Chapin
@ChapinMD
Disagree. Lots to consider and these trials all show minimal difference. Logistics of TP can outweigh ease of TR in specific circumstances. First publication showed no diff, now with 1 more infection the world has changed? I would support TR and defend it every time.
Thanks, Dr. Murphy.
Australia has shown the way on transrectal biopsies--and. you certainly have a strong position on pushing through the skin rather then the "poo."
Also, I find it interesting. that you say enough is enough--and not to fuss about randomized trials. Is common sense enough?
What can we US patients do to protect ourselves--especially since transperineals can be hard to come by in most communities in the US.
Howard Wolinsky
(Urologist in Melbourne here). This train left the station many years ago in Australia, and no way patients would accept TR biopsy here nowadays. In fact, it was patient advocacy that led to the Government increasing the reimbursement for TP biopsy a few years ago (and decreasing the funding for TR). Now, here in Victoria (where Melbourne is, about 7m people), more than 95% of all prostate biopsies are TP. In my centre (Peter MacCallum Cancer Centre), I banned TR biopsy in 2010 when I took over here. I personally last did a TR biopsy in 2007. None of our urology trainees have ever seen a TR biopsy.
My argument (trials notwithstanding) - why put the needle through the poo when we can put it through the skin?? It's nuts. Just because it's convenient (for urologists), is not a good reason. Plus we need to preserve antibiotics as they won't be with us forever.
Check out our podcast (search GU Cast) for episodes discussing this.
A Washington State reader responded to my commentary with a Vive la resistance!
He said: Hear, hear.
Dan Lin told me why not TP when I asked. Paraphrasing: too expensive to retool. (I'm guessing—also a pain to retrain.) Paraphrasing: infection rate just fine (implicitly because of antibiotics).
Still no biopsy for me. High PSA, but I learned about PSA density. I have a very large prostate. MRI I insisted on showed only a tiny equivocal lesion. (My radiologist) said good decision not to get a biopsy.
Dragged my heels on getting an ablation for urinary problems. Hard to find someone to do aquablation instead of a knife job. Problems abated despite not being ablated. Glad I waited.
Vive la resistance!
He aded this:
He asked Daniel Lin, MD, his former urologist, about TR vs. TP.
He said Lin, who is tops in the field, told him: (1) Urology departments have limited budgets and there are competing demands for resources; (2) UW infection rates are very low. Implicitly, therefore 1+2 = no compelling need to redirect expenditures toward new devices and idling perfectly adequate equipment or use new funds for the change.
Dale Bryant, a patient advocate, a Wisconsin transplant to British Columbia, is a good friend even though he is a Green Bay Packer fan. Go Bears. Dale is a leader in the Tri-Cities Prostate Cancer Group: https://www.tricitiesprostate.com/ He has set me straight at times when I needed it.
But he agrees that something has to be done by organized urology about the risks posed by transrectal biopsies. Worldwide, 3,000 men die per year rom transrectal biopsies, according to a leading Norwegian researcher. Good to have Dale in the foxhole.
The prospect of annual transrectal biopsies--which were common until a few years ago--were among the reasons he underwent a radical prostatectomy.
Here's more of what he says:
Hi Howard
Great article about transperineal biopsies, one of my personal issues that really disturbs me about the state of urology and Prostate Cancer. What seems like such a small percentage who suffer sepsis through transrectal biopsies gets magnified by every one of these damn things a guy has to have done. This was one of the factors that weighed into my decision for a radical prostatectomy 6 + years ago. I did not like the odds of staying on AS and having to have almost annual biopsies. After 5 years of annual biopsies (or almost annual biopsies), one's odds of contracting sepsis in the process approach or exceed 10%. I did not like those odds at all. With transperineals, the odds are basically nil of contracting sepsis, and with a much better level of accuracy given the hard to reach places they can get to in a prostate as opposed to transrectals.
Your following segment truly captures the reality of why doctors have not abandoned transrectals altogether:. Separate from the cost of buying the equipment, I think the real reason is that they don't want to take time away from their practice to learn a new trick, even one that will save lives. Kind of sad commentary on people we put a lot of trust in!
Some critics believe organized urology is deliberately delaying implementation of a pro-TP policy in the financial interests of its members, who would have to spend $40k to set up TP in their practice and take time to be trained in the technique. Medicare pays the same in physician fees for performing TR and TP, which takes more time and generates more costs, including general anesthesia in about half the cases.
Thanks for keeping up this important fight, Howard.
Dale
A couple weeks ago Bill Manning, the new executive director of Active Surveillance Patients International, and I led a support group for men with low-grade prostate cancer on active surveillance.
Two guys spoke up AGAINST transperineal biopsies. They said the pain was excruciating.
I pointed out they could have gone under anesthesia and also that some men find the pain is temporary. Also, again, the best estimates are that 2,000 U.S. men/year DIE from sepsis. Death from a biopsy aimed at finding a cancer that in many cases is no danger,
My good friend Jim Goodacre, another veteran AS patient, recalled this meeting in the following note:
Hi Howard: Remember in our seminar we had at the PCRI meeting in L.A. You were the moderator and one of the guys in the audience said that the TP Biopsy, he had was really painful and if he had his choice to do another one, he would do a TR Biopsy the next time.
Damn--too bad the TP Biopsy is a lot more painful. It is painful for the TR Biopsy I can't imagine more pain than that.
I am no stranger to handing pain since I have had 14 kidney stones. An interesting fact to find out is the men who died because of sepsis was it their first biopsy or was it a repeat biopsy.
I wonder if you can handle a TR biopsy without infection then what is the odds you will have a problem with the repeat biopsies.
I have never heard why the men who got sepsis got it to begin with? Why didn't the antibiotics work on the men who died? If antibiotics work on 98% of the men what is the reason it didn't work on the 2% of the men? Is there a test to determine if antibiotics will work on you before you take the antibiotics? Inquiring minds wants to know?
James W. Goodacre II RHU, REBC,LACP
P.O.Box 22423
Carmel, Calif. 93922
Phone (831)626-9250 or (888)735-5010
jgoodacre@sbcglobal.net
www.jamesgoodacre.com
Well, Jim, it is possible screen men with rectal swabs to see if they have antibiotic-resistant bacteria. If they do, special steps can be taken to provide IV antibiotics.
As Dr. Hu said,if you don't TPs available in your community, amnd many don't, this techique can make this TR biopsy safer.
This happened to me eight years ago. I had diverticulitis and taken heavy-dose antibiotics, which made me vulnerable to sepsis and other infections. So I had IV antibiotics. as a prep along with an enema and an antibiotic chaser, I came out fine.
A TP would have done the trick. And my urologist now does them.
Howard
Let's Move the Needle and save lives. Happy to hear from Dr. Jeremy Grummet, a long-time advocate for transperinal and a leader in the TRexit movement from Australia. With his permission, I reprint his note:
Hi Howard,
Thank you for your advocacy on this.
Prostate biopsy is not a sexy topic, but is arguably one of the most important topics in prostate cancer, given the sheer volume of these procedures done globally.
It was 2017 when I gave my Moving the Needle talk at the AUA plenary in Boston, debating the prominent Dr Ben Davies.
Ben has since converted to TP biopsy. (He would be a great person to talk to about this.)
Dr Hu’s RCT shows what we have seen in practice for well over a decade.
The most telling point of their RCT is the lack of sepsis in TP biopsy without ANY antibiotics.
Try doing a TRUS biopsy without any antibiotics and you’ll eventually end up with a dead patient.
So now the only way to do a “safe” TRUS biopsy is by giving “targeted prophylaxis” which means taking a rectal sample and seeing what bugs are living there. But this is far from foolproof as well, as there are numerous different flora residing in the rectum, and some can be missed on sampling.
The obvious question then is, why not avoid the rectum ENTIRELY, which is what a TP biopsy does, and you can forget about rectal flora and antibiotics? You can also forget about adding to the development of superbugs, which is what unnecessary use of antibiotics inevitably leads to.
It’s a no-brainer and has been for years.
Having watched the inertia on this in the US for years now, while the rest of the world has moved on, the cynical part of me wonders if the lack of guideline change there is due for reasons more financial/political than medical…
Feel free to use any of the above publicly.
Cheers
Jeremy
A/Prof Jeremy Grummet
MBBS MS FRACS
Urologic Surgeon and Prostate Cancer Specialist
Director of Urology
Alfred Health, Monash University
Former EAU Guidelines Prostate Cancer Panel Member
Co-Founder, MRI PRO
www.drjeremygrummet.com.au
www.mripro.io
Thanks, SRS.
Dr. Hu tells me one more positive randomized trial will do the trick.
But I think we patients need to vote with our feet and prostates--avoid transrectals. If you are worried about pain, consider general anesthesia. At the very least, if you have no choice but transrectal, ask that you be screened for nasty bacteria and ask for antibiotics. Time to rise up.
Howard
Howard, another home run. So many in the USA are totally unaware of Trans perineal biopsy. The AUA needs to update the guidelines and urologists have to be trained in the procedure.
Ray Scalettar, MD
Thanks, Dr. Scalettar. I appreciate the support. Readers may not knkw Dr. S., but he's past chairman of the board of the American Medical Association.
Howard,
Great commentary! You are an amazing prolific writer and advocate!
I especially loved your Szabo quote. Really good pun about getting “the needle to move”. Brilliant!
Jim, Thanks foir your comments. I don't understand why organized urilogy doesn't take this seriously, If Dr. Johanson is right, 2,000 US men and 1,000 others internationally are dying annually. How can urology just shrug its shoulders collectively and say 'Oh, well.' US men, especially, need to protect themselves and ask questions and take action.
Hey Howard,
that the trans-rectal prostate biopsy is licensed medical malpractice is old news. My urological colleague Anthony Horan MD underscored the dangers and lack of science surrounding the trans-rectal prostate biopsy in his book The Big Scare, published in 2009 and in his revised edition, The Rise and Fall of the Prostate Cancer Scam, in 2019. Anthony detailed the deaths from sepsis after trans-rectal biopsies and the fact that death certificates are unreliable. Everyone, including urologists, need to read these books.
In summary;
> how urologists are OK with the passage of a needle through a dirty rectum is beyond comprehension
> how urologists are OK with a 12-core sample size that biopsies randomly and blindly about 0.1% of the prostate is beyond comprehension - especially when prostate cancers tend to be multifocal
> both the trans-rectal and trans-perineal biopsy techniques are associated with gross sampling errors since only 0.1% of the prostate is sampled
> understanding the multifocal nature of prostate cancer and the incredibly small biopsy sample size makes a mockery of the upgrading and progression phenomena - these cancers were simply missed by the initial 0.1% sampling
> how these biopsy techniques can be deemed standard-of-care by physicians is beyond comprehension
> how these biopsies can be recommended in their AUA guidelines for prostate cancer is also beyond comprehension
Finally, and here’s the kicker;
> PSA testing/screening fails to save significant numbers lives
> treatments fail to save significant numbers of lives - at 15 years NO treatment had similar survival rates as surgery or radiation but without all of the complications routinely associated with treatment - the links to all these articles are in the blogs you published.
What the hell are we doing?
Cheers, Bert
Bert,
Yes. There are many angles here.
We have a doctor-created epidemic of overdiagnosis and overtreatment.
Dr. Johanson, based on his research in Norway, estimates that 2,000 men a year are dying in the US and 1,000 more in other countries from sepsis caused by transperineal biopsies.
My petition is at https://chng.it/skqzPrHrsN
Howard
Yes agree Howard - there are many angles.
Sadly, a major reason for the many angles is that the business of prostate cancer is ruled mostly by opinions, exaggerations and misrepresentations. The current recommendations for prostate cancer testing and treatment have only unleashed an embarrassing public health disaster. A catastrophe that could be corrected if physicians would support their recommendations with irrefutable and reproducible data.
cheers, Bert
https://www.atriumsurgical.ca/transperineal-prostate-biopsy-for-prostate-cancer/
The AUA demand for guidance by randomly-controlled trials is bullshit. If the AUA cared to gather evidence, there is now a sufficient proportion of TP biopsies that simply obtaining data on patient hospitalization and death after all biopsies would settle the question with only a few months of data. If the data are anonymized, they could be gathered from practices and their associated hospitals as an epidemiological research project.
Suggestion: Get in touch with Dr. Harvey Risch of Yale University. He is a top tier medical epidemiologist who showed great good sense during the Covid events. Dr. Risch might be willing to advise how to proceed with an epidemiological research approach to the TR vs TP question.