(Author’s note: Scroll down to see the first installment in this series.)
In my first installment on the Transperineal Biopsy (TPbx), I noted its history- the prevalence of the procedure for years before a drift back towards the TRUS bx. And we’re circling back to TP as possibly becoming a best practice: less risk of infection; friendlier in the office with local anesthesia (LA); the ability to choose general anesthesia (GA) for the procedure in an OR in a hospital; the possibility of no antibiotics administered before or after; less pain (still, a sensitive subject); and, most importantly, complete coverage of your prostate, including the anterior - where a large percentage of significant cancers are missed by a TRUS bx. I have mentioned that TP biopsies have been more prevalent in Europe; in fact, they are the standard of care in several countries and on the Australian continent. The US lags behind. More about that later. And although I’ve cited this 2020 abstract elsewhere in my blog, it might be a good time to revisit it. Click on:
“TREXIT 2020”: WHY THE TIME TO ABANDON TRANSRECTAL PROSTATE BIOPSY STARTS NOW
A program from the non-profit Active Surveillance Patients International in April 2021 on this subject featuring, among others, Rick Popert and Matt Allaway, can be viewed on ASPI’s YouTube channel: .
All Transperineal Biopsies Are Not The Same
Prevalent until the invention of the freehand (FH) technique has been the grid-based (GB) method. I’ve found some simple-to-understand text and accompanying videos to get you up to speed on the two techniques. A short and sweet article from The Journal of Urology with easy-to-understand explanations distinguishing between (GB) and (FH) transperineal biopsies can be found here.
Click on:
Freehand versus Grid-Based Transperineal Prostate Biopsy: A Comparison of Anatomical Region Yield and Complications
Conclusion: “Compared with GB TPbx, FH TPbx demonstrates an equivalent cancer yield with no risk of sepsis, a significantly reduced risk of urinary retention, and reduced anesthesia needs. The higher number of cores with ≥GGG-2 PCa involvement in the FH group suggests that FH transperineal biopsy can sample the prostate better than GB-transperineal biopsy can. "
For those of you more oriented towards visual presentations, watch this supplementary video to the above study from John Davis, one of the study authors (from The Journal of Urology, October 2021, copyrighted by American Urological Association Education and Research, Inc.)
A report from the Patient-Centered Outcomes Research Institute (PCORI) gives us a review on a trial expected to be completed in March 2025. Click on:
Comparing Two Types of Prostate Biopsy
And check out an online article from the Mayo Clinic from 2019, an excerpt of which follows:
“At Mayo Clinic's campus in Rochester, Minnesota, urologist Derek J. Lomas, M.D., Pharm.D., has chosen to discontinue routine use of the transrectal approach to prostate biopsy and now performs transperineal prostate biopsy. Dr. Lomas gained extensive experience with the technique during his fellowship training in London. Mayo Clinic is one of a few centers in the region that perform high volumes of transperineal biopsy….” [Note: this may have changed during the past three years]. “…..This approach helps to accurately diagnose threatening infectious complications associated with prostate biopsy. It provides good diagnostic yield and is particularly well-suited for patients with previous infectious complications," says Dr. Lomas." "There are several different techniques by which we can perform transperineal biopsy," says Dr. Lomas. "The choice of technique is based on whether a fusion or a systematic biopsy is needed and if the patient is in the clinic or under sedation.
"The first technique uses a device called a stepper, which is used to cradle the ultrasound probe and provide a guidance grid for biopsy needle insertion. Urologists who have performed brachytherapy for prostate cancer would be familiar with this device. The downside of this approach is that each biopsy of the prostate requires a skin puncture, which limits the utility of this approach in the clinic where we are using local anesthesia only. This technique may still be used, but an excellent skin block is paramount."
Mayo Clinic urologists also employ the freehand approach, using the needle access guide. "In this approach, only one or two skin punctures are needed for each side of the prostate," says Dr. Lomas. "Through a needle access guide placed through the anesthetized skin of the perineum, the biopsy needle can be reintroduced for multiple biopsies without repeat puncture of the skin. The biopsy needles are guided by an ultrasound probe in the rectum. This approach allows for improved patient comfort in the clinic setting.”
Read the article in its entirety here: https://prostatecancerinfo.org/40clV9O
My own fTPbx was performed with the PrecisionPoint Transperineal Access System (PPTAS) invented by Dr. Matthew Allaway, a urologist in Cumberland, Maryland.
Dr. Allaway is the Founder and CEO of Perineologic and strongly believes in providing an integrative approach to the treatment of urologic disorders. Many of his philosophies and attitudes regarding patient care resulted from his own personal battle with cancer, including his decision to become a urologist.
Dr. Allaway has been a practicing urologist at Urology Associates in Cumberland, Maryland for more than 20 years, with a special focus on prostate cancer and female urology. Many of the techniques and approaches he uses on a daily basis have resulted from ongoing clinical challenges and the need to improve the quality of care delivered to patients. These convictions contributed to his establishment of Perineologic and development of its first product, PrecisionPoint™.
He completed his residency in urology and surgery as well as his internship at West Virginia University. Dr. Allaway earned his Doctor of Medicine degree in osteopathic medicine from Midwestern University and his Bachelor of Science degree from Illinois Benedictine College. - from Perineologic.com
The doctor, who acknowledges that he's a "big adopter" of Active Surveillance, was growing weary of the risks associated with the transrectal biopsy. He described his thought process before inventing PPTAS: "why do we teach a method of biopsy [transrectal] where you don't even sample half the gland? [The reason] for that was research cited from decades ago that said.... 'there's just 5% of disease to worry about in other areas. I knew this was wrong, and I said we must sample the whole prostate properly."
The risk of infection in a transrectal biopsy - not often explained to a new patient who receives the biopsy for the first time - often in his urologist’s office - has always been on every patient's mind when choosing whether or not to have repeat biopsies during the Active Surveillance management protocol. And it certainly weighed heavily on Dr. Allaway's mind. "......The infections, of course, [created] a horrible situation....how can this happen in the modern era we live in? And [consider] the number of men who had low-risk disease, and on active surveillance...... the patients [were saying] 'you're absolutely never going to touch me [with that] biopsy again.'"
While Dr. Allaway approached outside sources to have his concerns addressed, they were met with skepticism. With the belief that "the urologist can do what they're skilled at doing, which is understanding prostate anatomy and knowing how to navigate around and get the needle in the right spot" he was steadfast in his belief that sampling the entire prostate made the most sense. "I don't want to be a microbiologist. I don't want to be an infectious disease doctor. I don't ...…want to use antibiotics at all.....I knew there was only one way to do this: to go through the perineum."
Expressing his dismay with the grid stepper technique, which he felt could cause too many complications, he recalls being "completely immersed with trying to create the very best possible biopsy." And thus, PPTAS came into being. "This is a procedure [which] can be done in the office safely, comfortably, and effectively."
Before I spoke with Dr. Allaway, I had done my research and had concluded that the only biopsy I would want was the PrecisionPoint. My first concern (remembering my first excruciating 12-core transrectal biopsy on a table in my first urologist's office five years ago) was PAIN. Would the local anesthetic for a transperineal biopsy be the same as administered for a TRUS?
Local anesthesia is not unique to PPTAS or other TP biopsies. We all know too well that a prostate biopsy is not the most comfortable procedure. As I stated above, many men choose to forego it on their AS protocols - instead, to rely on the results of a regularly scheduled 3T MRI, which has a false negative rate of around 15% - as of this writing. But the prostate biopsy is our only definitive tool to diagnose prostate cancer. Thus, reviewing some of the science and data on local anesthesia (LA) is worthwhile for those choosing a TP biopsy in an office setting.
A study in 2022 out of Australia confirms the viability of local anesthesia for a TPbx. Click on:
Outpatient transperineal prostate biopsy under local anesthesia is safe, well-tolerated, and feasible.
Conclusion: "TPB under LA in the outpatient setting is a safe and feasible practice. Our study adds to the current literature supporting the use of TPB under LA with high csPCa detection rates. It shows excellent patient tolerability while minimizing complications....."
I have been told that local anesthetic techniques are constantly improving. That is good news for those who wish to be mildly sedated but not wholly unaware of their surroundings. Doctors are exploring various sedation methods in an office setting, aware that our healthcare system is overburdened by the costs of having procedures in hospitals. And patients, as well, are forced - if they choose the OR - to find a friend or family member to meet them after they have recovered from general anesthesia when the biopsy is completed. Ergo, less of a burden on the patient as well.
One of the workarounds which have been suggested is the use of nitrous oxide - a mild sedation that wears off after several minutes upon the procedure’s conclusion. You and your doctor should discuss what would be most comfortable for you if you had the procedure in an office setting. I’ve known several patients who chose that setting - in different locations nationwide. One reported “no pain at all,” while another reported some discomfort. Several factors are in play here - the urologist’s experience and each individual’s threshold for pain. It’s similar when I read other accounts online, from “easy as pie” to “painful.” Again, I have been assured that discovering new methods for administering local anesthesia (LA) and improving current methods are ongoing. Hey, how long does it take to perfect anything on this planet? I know that if I had been offered the option for my own biopsy to inhale nitrous oxide, I might have chosen an office procedure. I’m very familiar with the mild sedative effects of the same since, over my lifetime, I’ve availed myself of nitrous for several dental and periodontal visits—different strokes for different folks. Frankly, I was happy to be asleep now that I think back on it. And I was fortunate to be met at the hospital by a fellow support group member.
To buttress the fact that continuing studies are taking place relative to transperineal biopsies and local anesthesia, check out these from clinicaltrials.gov. I found the following trials are still recruiting (as of March, 2023):
Evaluation of Transperineal Biopsy Under Local Anesthesia
Actual Study Start Date: March 22, 2021
Estimated Primary Completion Date: June 2025
Estimated Study Completion Date: June 2025
and the TRANSLATE trial: “The TRANSLATE randomised controlled trial aims to evaluate local anesthetic transperineal biopsy (LATP) versus transrectal ultrasound-guided (TRUS) prostate biopsy, in the evaluation of previously biopsy-naive men being investigated for clinically significant prostate cancer (based on an elevated age-specific PSA, or abnormal digital rectal examination, or MRI-visible lesion). Men under investigation for possible prostate cancer and recruited to TRANSLATE will be randomised to receive either an LATP or TRUS prostate biopsy, with the primary outcome measure being detection of clinically significant prostate cancer (defined as any Gleason pattern 4 disease, i.e., any Gleason Grade Group >=2 disease). Secondary outcome measures include infection, other complications, tolerability, rate of re-biopsy, detection of clinically insignificant prostate cancer, and a full health economics evaluation.”
Make it stand out
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
If you want to participate in trials that have been announced and are “still recruiting," read the requirements for enrollment and look for a contact nearest to you. (As I’ve iterated in early posts, clinicaltrials.gov is one of the main “go-to’s” for researchers. The site allows you to plug in keywords, and you’ll most likely find a trial that you might be interested in - either for research or participation. To participate, choose the field “still recruiting.” If you’re searching for studies from which you can glean conclusions from an entire abstract from start to finish, choose “complete.” It’s that simple.
Now let's dive in to some of the questions I had before my own freehand TP (fTP) biopsy last September and questions which arose afterwards. Let me be clear that, from hereon in, I’ll be focusing on the freehand PrecisionPoint Transperineal Access System (PPTAS) biopsy which was, again, my third biopsy in September 2022, four years after my confirmatory biopsy.
Aside from PAIN and local and general anesthesia, I was additionally curious about bowel preparation and antibiotics - the latter prevalently used in transrectal biopsies, particularly the "black box" CIPRO. With transperineal biopsies, administration of antibiotics are normally left up to your urologist while the manufacturer of PrecisionPoint, Perineologic, is upfront about the device not requiring the administration of antibiotics before-and-after. Dr. Allaway and I circled back to his strong feelings about antibiotics, supporting the burgeoning evidence from studies of the dangers of over-prescribing antibiotics to the point where many become anti-biotic resistant, exposing patients to irreversible infectious conditions. This was certainly a factor in my pursuit of a practitioner and facility which utilized PPTAS. (I was not given antibiotics). However, I’ve known patients who, upon undergoing the PPTAS biopsy by urologists trained by Dr. Allaway’s team, were given antibiotics before-and-after. So, what gives? I discussed with Dr. Allaway' his intention around obviating the need for antibiotics and did my own research as well.
But, first, here is a "meta-analysis" of which Dr. Allaway is listed among the authors:
Role of Prophylactic Antibiotics in Transperineal Prostate Biopsy: A Systematic Review and Meta-analysis
See also this report of a randomized controlled trial - published in Lancet Infectious Diseases - where they randomized patients to transperineal biopsy with and without antibiotics and found no difference in infectious complications:
Antibiotic Prophylaxis versus No Antibiotic Prophylaxis in Transperineal Prostate Biopsies (NORAPP): a Randomised, Open-label, Non-inferiority Trial
Dr. Allaway's intention for patients undergoing PrecisionPoint biopsies is not to be administered antibiotics; however, he and other urologists know that others can conceivably develop arguments for antibiotics. In the end, it's up to the doctors. It could also be up to the institutions under which some urologists practice. It's debated, which is expected, as in any other practice and profession. But sometimes, doctors’ hands are indeed tied by institutions. This goes directly to your choice, the patient's choice. If you arm yourself with information and scientific data, such as the studies cited above, you can bring it to the table with your doctor, and a discussion can occur. After all, isn’t that the essence of shared decision-making?
Dr. Allaway's passion for eliminating antibiotics for PPTAS is evident:
“I've seen some groups using Meropenem, [an antibiotic] which covers ... very resistant [and infectious] strains.....and they say...well, we'll just give the patient a dose here and there...and my feeling is that this type of antibiotic can create much harm. I just can't accept that."
I looked up Meropenem on Dr. Google and found corroboration that it indeed is one of the more potent antibiotics around with a myriad of side effects. I'll leave it to you to investigate for yourself. The point is, Dr. Allaway underscores the overuse of antibiotics in general. Read this insightful piece from the Mayo Clinic:
Antibiotics: Are you misusing them?
And for good measure, read this from the CDC, which has completed statistical reports through 2021. The overuse of antibiotics — especially taking antibiotics when they're not the correct treatment — promotes antibiotic resistance. Period. prostat...nfo.org/40dyXUk
Given the penchant for the overuse of antibiotics in this country, Dr. Allaway (and others in the camp of supporting no antibiotic administration for PPTAS transperineal biopsies) admits that exceptions exist. "[In an instance where a patient ] had a - what we like to call a trans-fecal biopsy - within six months of a TP biopsy, I would recommend you consider giving him an antibiotic because a study out of South Korea showed that bacteria hide in the gland after a transrectal biopsy."
New Bacterial Infection in the Prostate after Transrectal Prostate Biopsy
Dr. Allaway continued: "...We're basically inserting bacteria into the patient's prostate that gets whisked up by the bloodstream. And so, theoretically, even if the patient has normal urine and no symptoms, if you go in [utilizing the TP technique], it would be like poking a hornet's nest."
While he's still not 100% convinced it would be absolutely necessary to administer antibiotics for the patient example he mentions above, I understand his care for patients and the principle of proceeding with caution. He admitted a bit of trepidation when he stopped administering antibiotics as it went against the grain of current practice. The ensuing meta-analysis and randomized trial (links above) gave him confidence and instilled the same in other prominent urologists performing the PPTAS biopsy.
" I [hadn't been] aware of anybody that was eliminating them completely....but it's always been my kind of m.o. in practicing that if I feel strongly about what's right for the patient, I'm going to do it."
He continued to describe his practice of ensuring no contaminants were present in the area where he began to perform the PPTP biopsies. And he set up a parameter of one year from a man's TRUS biopsy to feel comfortable enough to perform the PP without antibiotics. However, he demonstrates his keen understanding of when to make exceptions: "If the man had sepsis after a transrectal biopsy, then I would choose to cover him [with antibiotics]. And then there are rare examples, patients who tell me they have [for instance] a fresh knee or hip replacement, and [they] express fear about [having the area subject to] infection." He complies with the patient's wishes even though he may feel it's debatable.
This is a doctor who cares about his patients.
He cites "99% elimination [of TRUS biopsies] in Western Maryland," where he practices. "Transrectal has gone out the window; there hasn't been a single transrectal biopsy, and [in] roughly six and a half years, we've looked at the data, and we keep track of every single patient and every single core taken from every patient.....zero hospitalizations, zero sepsis...." He continues to cite less than 0.5% side effects such as urinary retention. And, since the inception of PPTAS, he states: "we went from, roughly 38% to now 70% [n cancer detection]."
SO…….What’s the Story with the Bowel Prep and/or Enemas?
While I did not bring this up in my conversation with Dr. Allaway, I knew from Perineologic's website that PPTAS is set up with the intention to not have the patient undergo any bowel preparation before the procedure.
As an aside, it has been my experience that this topic is not exclusive to biopsies. I remember a renowned nationally prominent Dr., who shall remain unnamed, vilifying the institution where I received my first prostate MRI. “You should have been advised to take an enema beforehand,” I remember him saying. He continued with words which suggested that the report from the radiologist might as well go in the trash. Since that time, I’ve known some patients who were asked to take something akin to the Fleet enema before an MRI; others not. Institutions differ. The machines differ. Radiologists differ. Do your homework. Find an experienced radiologist and find out the requirements beforehand. Enema? Contrast? (for another post….)
Where the biopsy comes into play, I’ve been asked until this past (third) PPTAS biopsy to give myself an enema. I double checked with the pre-op department several times at Brigham - “are you sure I don’t need to take an enema?” Because I remembered that four years previously, when I had an in-bore GB transperineal biopsy, I needed to give myself an enema several hours prior to my arriving at the hospital. But, for this PrecisionPoint biopsy at the same hospital, this past September, there was no such requirement.
There are, however, doctors who, even performing the PrecisionPoint biopsy, prefer the patient take an enema pre-biopsy. (I remember five years ago - for my first AND LAST transrectal biopsy, I was required to take an enema). I have made some inquiries, for this article, of other doctors and I've concluded that it's pretty much up to them. It also has to do with the equipment they use. If a patient prefers to not take an enema - and the doctor agrees - than the option remains open.
I hope this discussion around antibiotics, anesthesia, and bowel prep before undergoing a TP biopsy will give patients some guidance to make informed decisions with their doctors. I cannot emphasize enough how these issues are bandied about in patient support forums. And those who fervently oppose antibiotics often use that as a reason to postpone their biopsies. But now, with PrecisionPoint, there is data which supports that there is no need for them, with exceptions, as noted.
Dr. Allaway and I segue to a discussion on his rigorous procedures of training and certifying other urologists in the use of PPTAS.
The doctor tells me: “I don't want anybody to use the product unless they [really] know how to use it. Because if you don't understand how it was engineered and how you're supposed to navigate the anatomy, you could easily perform a bad transperenial needle biopsy.....if you don't know how to get the needle in the right spot....." He continued: "And [although] training is so expensive, [it is] important for us as a company. A doctor must be certified - signed off by me or one of our urology trainers. Our representatives are out in the field before you can buy a device....Quality is so important here. My goal is not just to sell as many devices as possible. My goal is to try to transform the technique... having it standardized so everyone gets the very best results."
Since PPTAS has hit the international prostate medical community as a near certain alternative to the TRUS biopsy, it has had its most tremendous growth in Europe. This is not surprising, since the European Association of Urology (EAU) included in their guidelines in 2021 their recommendation of the transperineal biopsy over the transrectal. The UK, Sweden, and more than a dozen countries have urologists trained in PPTAS.
(see summary on page 36 for European guidelines on prostate biopsies)
And with headlines like this, among other studies in Europe, who could blame them?
Transperineal Prostate Biopsy Is the New Black: What Are the Next Targets?
and from the british journal of urology:
Detection of Clinically Significant Cancer in the Anterior Prostate by Transperineal Biopsy
AND LET’S NOT FORGET ABOUT AUSTRALIA!
Australia dropped the reimbursement to physicians by 50% and increased payment for those performing transperineal biopsies 30%. The movement to make the transperineal biopsy the standard in Australia was driven by patients who simply felt it was a safer biopsy.
Progress has been slower in America. First, guidelines have not been as quick to embrace the transperineal method although there remains hope that the evidence will overwhelmingly support their inclusion in the not too distant future.
Finally, I leave you with a podcast you’ll want to listen to. Dr. Allaway chats with Dr. David Canes about PrecisionPoint, and “his journey towards changing the paradigms of prostate cancer diagnosis.” Access it here:
This concludes Part 2 of the Transperineal Series. The next installment will include issues around “coding” for insurance reimbursements to doctors in the US, additional thoughts and videos from Dr. Allaway.