Transperineal Biopsies – AnCan’s favorite Standard Bearer explains!
If you’ve been around AnCan’s prostate cancer programming, and for sure our Active Surveillance and Low/Intermediate Groups, you are certain to know AnCan moderator and medical journalist Howard Wolinsky. He has campaigned on many issues impacting men like him with very low, low and intermediate risk prostate cancer. The list is long – and included below!
Howard has three signature campaigns. He has worked ceaselessly to expand the number of men diagnosed with very low, low and low/intermediate risk prostate cancer who are treated with the active surveillance protocol. He is a founding member of the medical group advocating to rename very low grade prostate cancer something other than cancer. It recently dawned on us that AnCan, one of Howard’s ever present platforms, had never blogged on TPs.
TPs avoid the germy rectum and virtually never cause infections or potentially deadly and disabling sepsis, although nothing is 100%. The biopsy needle is placed through the perineum, the space between the rectum and the testicles. This is not only patently more hygienic avoiding all fecal material, but also allows access to posterior areas of the prostate that cannot be reached with the TR protocol. Here’s an excellent short video to better explain.
Over 800 people—fellow patients and some leading physicians—have signed his petition to phase out transrectal biopsies. Wolinsky called on Medicare and Congress to intervene after a scandal in Norway caused the European Association of Urology to take on the issue in 2021 when a Norwegian died from sepsis following a prostate biopsy. The policy head of EAU told Wolinsky that transrectal biopsies were tantamount to “malpractice” in Europe. Wolinsky moderated a debate on TP vs. TR at AnCan in 2022 AnCan also ran two webinars on the topic in 2022:
So what did the American Urological Association do?
You might expect some resistance to a major change in practice that’ would cost urologists time to be trained and up to $40,000 in equipment to set up this new approach. That’s what happened. Wolinsky, representing AnCan, as a consumer reviewer, told the AUA Early Detection Guidelines in 2023 that they should recommend transperineal biopsies as the preferred method. He said men were dying while they were debating which end of the egg is better to break first.
AUA still put TP on par with TR in its guidelines. A small step for men, as Neil Armstrong said on the first moon landing. The AUA is conservative and says it requires high levels of evidence from research before changing its guidelines—even though EAU counterparts consider TP their preferred method. Daniel Lin, MD, vice chair of the AUA committee, said in 2023 that randomized clinical trials would be the key to resolving the issue and several were coming in the next year.
Dr. Badar Mian’s single-center RCT at the University of Albany showed TR and TP essentially had the same results in terms of infections. It was widely criticized for not having enough patients to reveal rates for sepsis.
Dr. Jim Hu’s multi-center study based at Weill-Cornell “almost” showed a statistical benefit to TP in a paper presented last January. But no cigar. The study was expanded and it is clear that TP wins in this research. Hu told the recent AUA meeting about it, but won’t talk about the results until the study is published.
But TP, meanwhile, is in increasing demand. A poll of 145 AS-educated readers of TheActiveSurveillor.comfound that 36% had undergone a TP biopsy – far above the national average of 15% now and 10% two years ago. 54% of respondents expect to undergo transperineal procedures in their next biopsies.
None of this is say biopsies should be eliminated, just that they should be done as necessary and as infrequently as possible. A decade ago, urologists recommended annual biopsies. As their confidence in AS has increased, the frequency varies by practice: from every other year to three to five years as in Dr. Klotz’s practice in Toronto. Wolinsky’s own care as a peer in this Active Surveillance cohort has de-intensified with annual visits to his doctor, Dr. Brian T. Helfand | NorthShore He has not had an MRI or biopsy in eight years–though his doctor still considers Wolinsky on AS. At age 76, he is considering hopping off the AS train.
Just in case you think Howard is a one-track (or even three-track) pony, here are a few other issues he has undertaken on behalf of men living with very low, low and intermediate prostate cancer.
Where in the world is best for a radical prostatectomy?
Ever wondered whether medical tourism makes sense for a radial prostatectomy? After all, most of us are well aware that a RP comes with significant expectations for erectile dysfunction and incontinence. A recent paper in JCO Global Oncology analyses surgical outcomes in 10 countries covering almost 22,000 men, although by far the most (72%) come from Germany. Notably none are Scandinavian where we already know Active Surveillance (AS) for men with Low/Intermediate risk prostate cancer (PCa) is highest.
If you’ve been paying attention to our AS Mods, in particular Howard Wolinsky, you will already know that the US lags far behind when it comes to treating suitable men with AS. This study confirms 84% of men treated in the US were Stage 1 and 26% were Grade Group 1. Only the Barbers of Seville performed more aggressively treating 88% of T1 and 27% in GG1. The Brits were way out ahead treating just 13% of men with T1, 9% in GG1. G-d Bless the National Health Service and its cost saving measures.
Sexual dysfunction reported a fairly tight band between 40-53%. The happiest campers were those singing Waltzing Matilda in Oz, while the Brits were the loudest complainers, although Canada was slightly higher when weighted. US was in the middle.
Those Spanish toreadors caused the most urinary bother at 54% (33% when weighted) albeit 29% reported issues going in. The Italians only reported 1% after surgery and 10% before… either those Italian surgeons are true maestros, or the Signore are not being honest. USA was right around average at 9%.
The main caveats in the study are the huge variance in respondent numbers between countries with a heavy bias to Germany. The researchers also recognize that men in different countries may answer the survey referencing different standards. All told, this is the fist ever comparative study… and for me personally, I’d stick to the beaches and the Prado when visiting Spain!
There are a lot of numbers to plough through here, and a Mike Wyn deserves a big shout out for helping us get through them. If you want to dig into them yourselves, you’ll find the link at https://ascopubs.org/doi/pdfdirect/10.1200/GO.23.00420
Join us for this ‘ripped from the headlines’ webinar featuring a hot topic in the Active Surveillance community.
When world famous physician-scientist, leader of The Human Genome Project and former NIH Chief, Dr. Francis Collins, suddenly needs treatment for his prostate cancer that has accelerated from indolent to aggressive faster than a Formula 1 racer, many patients and medical professionals ask – whats up?
The NIH/NCI is considered one of the best medical institutions in the world. Did their active surveillance (AS) protocol fail or was Dr. Collins an anomaly? Do patients need to worry? … and is ‘cure’ really a possibility for Dr. Collins?
At short notice, AnCan Foundation, ASPI and The Active Surveillor have gathered together two world-renown urologists who curate their own AS cohorts. Drs. Peter Carroll and Laurie Klotz will discuss their views on the safety of pre-treatment AS for prostate cancer. Howard Wolinsky will moderate the discussion. AnCan’s own AS Support Group Moderators will be speaking after the presentation sharing their own thoughts
Watch here: (closed captioning is provided for this webinar, click the CC button at the bottom next to the gear.)
Special thanks to Bayer, Novartis, Johnson & Johnson, Myriad Genetics, Telix, and Blue Earth Diagnostics for sponsoring this webinar.
For information on our peer-led video chat PROSTATE CANCER VIRTUAL SUPPORT GROUPS, click here.
To SIGN UP for any of our Virtual Support groups, visit our Contact Us page.
What’s in a Clinical Trial? – Dr. John Antonucci’s Primer
On Tuesday, February 27 a squadron of AnCan specialists attempted the impossible: to condense the essence of arguably the best scientific meeting on genitourinary cancer research in the world into 1 hour of intelligible, useful information. A couple of hundred scientific poster and oral research presentations from the American Society of Clinical Oncologists annual GU meeting (GU ASCO24), made available and understandable to us AnCan’rs? You can view their attempt as well as the slides at https://ancan.org/patient-highlights-from-the-2024-asco-gu-conference/ and judge how they managed.
To prepare for the session, a basic understanding of research is very helpful. It starts when scientists comes up with a question. For example, “Does Lupron do any good?” They then design a study to answer the question.
Types of studies:
Not every study is an experiment. In an experiment, the scientist does something to the subjects, such as try a new drug, and compare them to a control group, which doesn’t get manipulated. In observational research, the scientist studies the subjects but doesn’t do anything to them.
Randomized controlled trials (RCT) are a type of experiment that are highly thought of. If you want to find out if Lupron is any good, you can find 2 groups of subjects with prostate cancer, give one group Lupron, and the other group a placebo (ie no medicine, although you still administer the fake dose). You have to be careful that the 2 groups match, because if you accidentally put most of the healthy patients in group A, they will do better but mess up your conclusion. This is the controlled part: you have to make sure both groups match except for the experimental manipulation. This is partly done by randomizing, assigning the subjects at random to the groups. At the end, you find out how long each group lived (or some other pre-established endpoint) and make a conclusion. This type of study is an experiment. It is also prospective: you create data as you go along which makes it a good study.
One of the several types of observational studies is the cohort study. Cohort studies follow groups to see how they do. For example, you could follow 1000 men over time, and see if the smokers get more prostate cancer than the nonsmokers. This could give a clue into what contributes to prostate cancer and how to prevent it. These studies are often prospective (looking into the future) but can also be look-back, or retrospective as well. A well-known cohort study in prostate cancer is the Canary Cohort that looks at low/intermediate Active Surveillance; or the Framingham Heart Cohort.
A cross-sectional study can answer questions like, what percentage of 50-year-old men have had a PSA test? You have 500 fifty year old men answer the question, and get your conclusion. It’s at one point in time. (The opposite is a longitudinal study, following subjects over time.)
Qualitative studies don’t collect numerical data like the others. If you want to find out what life is like on Lupron, you interview lots of men on the drug and get the big picture. The opposite is quantitative, where numerical data is collected.
Naturally, it makes sense to have lots of subjects in any study so you don’t get fooled by chance. For instance, you could flip a coin twice, get heads twice, and wrongly conclude that all coin flips will be heads. So big studies are better than small ones. The number of subjects in a study is known as n. Small ‘n’smake results suspect.
The chosen study type depends on the question, the ethics, and the resources. Only an experiment, like an RCT, can make a cause-and-effect conclusion, because it’s randomized and has a control group. Other studies can discover correlation; that’s when two phenomena occur together but causation is unclear.
There are studies of studies as well: A Meta-analysis will review and combine several similar studies to make the results even more convincing. A Literature review will review many studies, pick the best, and create a summary for us.
Basic science research uses instruments like petri dishes and microscopes to study molecules or cells or tissues; these are in-vitro studies. Lupron started in basic science research. Then it progressed to animal or in-vivo studies. Treatments that look promising at this stage progress to human clinical studies.
Clinical Trial Phases
You will hear human clinical studies presented as Phase I, Phase II, or Phase III studies. According to the FDA, Phase 1 has 20 to 100 healthy volunteers or people with the disease/condition. It lasts several months and is to test for safety and dosage. About70% of drugs move to the Phase 2, where up to several hundred people with the disease/condition are studied for several months to 2 years looking atefficacy and side effects. Approximately 33% of drugs move to phase 3, where 300 to 3,000 volunteers who have the disease or condition are studies for 1 to 4 years to deeply look at efficacy and monitoring of adverse reactions.
A drug like Lupron, when it did well at all these phases, was then submitted to the FDA for approval. After approval it was still followed, in phase IV or post-marketing research, as it was given to thousand of patients. Keep the phases in mind if you volunteer to be a research subject.
Clinical tests One last thing. How do you measure if a test is any good? What if someone asks, “Is PSA any good as a test for prostate cancer?” There are two key measures to consider: sensitivity and specificity. Sensitivity asks, “If prostate cancer is present, how good is the test at detecting it?” This measures the test’s ability to identify those with the disease correctly. Specificity, on the other hand, asks, “If prostate cancer is absent, how good is the test at correctly identifying those without the disease?” This measures the test’s ability to identify those who don’t have the condition correctly. Both measures are crucial in evaluating the effectiveness of a diagnostic test.
Clinical tests can be either predictive–A predictive test is designed to predict the likelihood of a specific outcome or response to a particular treatment or intervention. –or prognostic–a prognostic test is used to estimate the likely course or outcome of a disease, regardless of treatment.
Your AnCan team looked at all those ASCO meeting presentations with an eye toward good study design, importance, whether it’s an experiment or not and if so what phase it is, is it prospective, does it have a large-n, and is it of interest to men in our group. Hopefully reading this will make it easier to understand the ramblings of our AnCan Mods.
Bang your drum… it could make you smarter and healthier!
I don’t want to work I want to bang on the drum all day I don’t want to play I just want to bang on the drum all day
–Todd Rundgren
Twice in the last several months, the topic of drumming came up in our AnCan Men Speaking Freely group and it generated some excitement both times. So this month’s invite will be on that topic.In my former practice whenever I have given a non-verbal treatment there is a big relief that no talking is involved. In bypassing the verbal and left-brain systems we gain access to a typically unused part of ourselves. I wonder if we can use this approach to cope with our serious illnesses and have a better life?
Our brains have a characteristic called plasticity, the ability to change. You may have heard of this regarding the little finger brain circuit of violinists; it grows as they become proficient. Drummers also have different brains than the rest of us. They have fewer, thicker nerve fibers between the two halves of the brain. They have more efficiently organized motor cortices. (Schlaffke, 2019). Because of this, drummers can do things that we can’t. They can coordinate the two sides of the brain better, and perform motor tasks with greater efficiency. They can play different rhythms with each hand and foot at the same time.
Schlaffke’s subjects had drummed many hours per week for decades. But Bruchhage’s (2020) subjects trained for only 8 weeks and showed several changes in the cerebellum plus changes in the cortex, showing not only cerebellar plasticity but also communication and coordination between the cerebellum and brain sensorimotor areas as well as areas for cognitive control.
Drumming is very complicated, which is why it’s unfair that the lead guitar and vocal guy gets all the girls (Greenfield, J. 2022).
For some reason, there is a close association between beat synchronization (integrating auditory perception with motor activity) and reading ability in children (Bonacina, 2021). Higher synchronization ability predicts better literacy skills. Maybe early intervention involving drumming can improve literacy in kids?
Cahart et.al (2022) showed that drumming can improve behavioral outcomes for autistic adolescents and elucidated some of the neurology involved. Does this mean it could help us?
Drums have been used for millennia for healing, inducing trance, and even psyching up soldiers.
We have learned that drumming is not just about waking up the right brain, but also about connecting the sides of the brain, and the cerebellum with the cortex. It can induce alpha brain waves. It can release endorphins. Even T-cells respond to drumming (Bittman). It induces present-moment experience, which we often work toward to deal with death anxiety. Interpersonal connections are made when people drum together. Despite the effort involved, it induces relaxation. I have come across papers describing drumming and music therapy for a wide variety of emotional problems and currently, there are 8000 music therapists in the US.
How about for us? We see above the possibility of reductions in anxiety, tension, pain, isolation, depression, and over-thinking the past and future. There are many studies of music therapy in ICUs, with patients on ventilators, easing hemodialysis pain, with positive results. Also, helpful with narcotic use, social integration, and depression. MSKCC uses music therapy.
With terminal cancer, there is data showing that music helps breathing, QOL, psychospiritual integration, reducing pain in chemotherapy, radiation, and helps pediatric breast and lung Ca patients (Ramirez 2018, Hilliard 2003, Burns 2015 Tuinmann 2017, Barrera 2002, Li 2011, Lin 2011). Atkinson (2020) found improvement with fatigue. I couldn’t find any studies focused only on Prostate Cancer.
Well, all this scholarly stuff is really unnecessary to anyone who ever banged a pot with a wooden spoon. Kids love it. Adults love situations where it’s OK to be wild and make noise, such as drumming circles and Pound classes. It’s just fun and feels good.
Dr. John Antonucci
Editor: Dr. John wrote this for our Men Speaking Freely Reminder on Dec 7, 2023. It’s such a perceptive, helpful and instructive piece, AnCan wanted to share it widely.
Last month’s Under 60 Stage 3 & 4 Prostate Cancer meeting was small, intimate and produced a true gem from Down Under to benefit all AnCan’rs …
For the life of me, I forget what raised the topic … maybe a Death with Dignity discussion – but Aussie AnCan’r, Steve Cavill told us about the ICE “In Case of Emergency” Checklist Document that he and his wife Leonie, who occasionally attends our Care Partners Group, have both completed. Steve and Leonie reside in the suburbs of Melbourne and are currently heading towards mid-Winter.
This ICE Checklist takes much, if not all, the difficulty out of placing your key information in one place. Like your vital passwords to your laptop, phone or bank accounts; names of key individuals in your life and more. You know .. all that information making it possible for someone to piece your life together if you’re suddenly no longer with us.
Frankly it’s information we should all compile no matter how old. With this checklist guide at hand to march us through it, there can be few excuses. Just remember, this version of the ICE checklist was created in Oz, so it may not be fully applicable Stateside. If one of our US volunteers has time to ‘Americanize’ it, I feel sure it will be greatly appreciated – we have very few solicitors in the US and a few too many attorneys!
Here’s the checklist document in Word format ICE Document Template Now do your part …. and a BIG THANK YOU, Steve Cavill!!
above all, to make biopsies safer. He started this campaign with an article entitled “No More Men Need to Die From Transrectal Prostate Biopsies” in MedPageToday on April 21, 2021. He has called for TR biopsies to be replaced by TP biopsies in his newsletter TheActiveSurveillor
Ever wondered whether medical tourism makes sense for a radial prostatectomy? After all, most of us are well aware that a RP comes with significant expectations for erectile dysfunction and incontinence. A recent paper in JCO Global Oncology analyses surgical outcomes in 10 countries covering almost 22,000 men, although by far the most (72%) come from Germany. Notably none are Scandinavian where we already know Active Surveillance (AS) for men with Low/Intermediate risk prostate cancer (PCa) is highest.
With terminal cancer, there is data showing that music helps breathing, QOL, psychospiritual integration, reducing pain in chemotherapy, radiation, and helps pediatric breast and lung Ca patients (Ramirez 2018, Hilliard 2003, Burns 2015 Tuinmann 2017, Barrera 2002, Li 2011, Lin 2011). Atkinson (2020) found improvement with fatigue. I couldn’t find any studies focused only on Prostate Cancer.