Uro-critic Vorstman: What's wrong with active surveillance for prostate cancer? What’s wrong with prostate cancer testing and treatment?

Happy Father's Day.

(Editor’s note: Uro-heretic Bert Vorstman, MD, wrote his first guest column here in May 2022. His essay, “Uro-Skeptic Vorstman Sounds Off: 'PSA Testing, Active Surveillance and More Damned Lies,” attracted over 3,000 readers, the most of any article to date. You can follow him at https://urologyweb.com/

(Vorstman’s motto is: ‘It's high time someone with balls stepped up to the plate and demanded that we return to scientific principles and stop the bullshit.” You and your urologist may challenge his provocative views. He provides links to his evidence.

(Personally, I support AS as the best option for low-risk prostate cancer who’ve undergone a biopsy. See below. Please feel free to sound off in the comments section above.)

By Bert Vorstman MD

Active surveillance is a monitoring program for low-risk prostate cancers that puts off “treatment” unless, in the unlikely event, that it progresses. But, how reliable is the program used to detect prostate cancer and progression? Or, does this active surveillance scheme merely spotlight again the abject failure of the prostate cancer testing and treatment program to help and protect the vulnerable?   

What are low-risk prostate cancers and are they real?

Both the Gleason 3+3=6 and the Gleason 3+4=7 are commonly categorized by urologists as low-risk prostate cancers. But, the genetic pathways of the grade 3 for cancer development and spread are inactive. Therefore, by definition, the pure grade 3 is NOT a cancer or, even a low-risk cancer. And, underscoring this reality is the fact that clinical studies indicate that the grade 3, as in the pure Gleason 3+3=6, follows a harmless course.

So, how did this cancer label for the grade 3 come about? Well, a long time ago, the grade 3 was thought to have some low-power microscopic appearances suggestive of a low-grade cancer. However, eventually it became apparent that these looks did not translate to cancer behavior for the Gleason 3+3=6. Yet, although urologists were well aware of this finding, they chose to continue with the deception instead of protecting victims from over-testing and over-treatment by relabeling the disease. As a consequence of this inaction, countless numbers of terrorized men continue to be fooled about the Gleason 6 and railroaded towards risky radical treatments that leave life-long complications and are without evidence for life extension. As well, this misleading cancer label has skewed prostate cancer statistics, invalidated virtually all prostate cancer treatment studies and resulted in the convenient denial or cancellation of innumerable life insurance policies.

(Bert Vorstman, MD)

How fast do low-risk prostate cancers grow?

Low-risk, favorable risk, well-differentiated, low Gleason grade, and low Gleason score prostate cancers grow very slowly. For these cancers, a mean cell doubling time of 479+/-56 days has been recorded. This rate of division means that it can take about 40 years or more from the time of a cell mutation for the growth to reach a tumor size of one centimeter (about half an inch) in diameter. Clearly, this incredibly slow cell division rate means that the diagnosis of a low-risk prostate cancer is not a treatment emergency and likely, will never require treatment. As well, it questions the urologist’s logic behind 6 monthly or even 12 monthly testing. 

Prostate cancer, multifocal disease, and field effects.

A common misconception about prostate cancer is that it’s only in one spot of the prostate. It may be a single focus of cancer, but prostate cancer tends to be a multifocal disease meaning that it can develop in more than one area of the prostate. Frequently, in 1-5 different parts of the prostate and, not necessarily at the same time or of the same grade. This multifocal nature of prostate cancer is due to the phenomenon of field effects. This means that much or all of the prostate tissue (more so in some individuals) has been prompted (by an unidentified mechanism) to become cancerous at some point in time. As a consequence, field effects can result in cancers occurring in various locations of the prostate, at some time and of an unpredictable grade. However, most cancers that do arise are low-risk.

Tests used for active surveillance.

The tests used by urologists for active surveillance are the same unreliable tests used for prostate cancer screening and detection. For the surveillance program, urologists commonly recommend six monthly PSA (prostate specific antigen) testing - including PSA derivatives and PSA kinetics, 12 monthly prostate exams and 12 monthly prostate biopsies to “check” Gleason grades and scores (and maybe, a 12 monthly MRI - if allowed by your insurance plan). Urologists believe that a change for the worse in one or more of these tests can indicate whether a low-risk prostate cancer is advancing. That is, evolving, upgrading or progressing and requiring treatment. However, there is no hard scientific evidence that the various Gleason grades themselves often evolve, upgrade or progress. And, more worrisome, not only are these unreliable tests also impacted by laboratory and observer error, the definitions used to determine when surveillance should be abandoned and treatment be initiated vary widely according to urologist and various “guidelines”.

The PSA and random prostate biopsy hoax.  

Shockingly, it's already been established that both the PSA and prostate exam (the prostate exam has been abandoned by many European urologists) are highly unreliable when used to screen for prostate cancer. So why would these tests now be trustworthy for active surveillance?

The PSA has a false positive rate of 78 percent as it is not specific for prostate cancer but more reflective of benign prostate enlargement. In fact, many low-risk cancers are detected by chance because the PSA was elevated by the enlarged prostate and not the cancer. More concerning, the important 10-15 percent high-risk, potentially deadly prostate cancers often make a little or no PSA and can go undetected.

Yet, incomprehensibly, despite the knowledge about the PSAs many flaws the FDA (Food and Drug Administration) gave PSA testing an approval for prostate cancer screening in 1994. In contrast, the USPSTF (United States Preventive Services Task  Force) gave PSA-based prostate cancer screening a “D” grade in 2012 as “the benefits did not outweigh the harms”. Disturbingly, this important ruling was quickly challenged and watered down to an ineffectual “C” grade in 2018 by self-interested urology groups. An astounding misguided response when their own studies published in 2009 had already concluded that PSA testing failed to save significant numbers of lives. 

The prostate needle biopsy is another grossly unscientific test also associated with potential bleeding and sepsis complications. The ultrasound-guided 12-core prostate needle biopsy (whether transrectal or transperineal) samples blindly and randomly about 0.1 percent of the prostate - when the volume of the 12 cores are measured against the volume of an average size prostate. This means that the diagnosis and management of prostate disease is established on the basis of a ridiculous 0.1 percent sampling while the status of the 99.9 percent rest of the prostate remains unknown. Since many prostate cancers are multifocal, it is hardly surprising that this 0.1 percent hit-or-miss sampling from one biopsy to the next misses or detects cancers. If it misses or finds a similar cancer by chance somewhere it gives the impression of stability. If it hits cancer (that was likely missed previously), that is of a different grade and score it gives the impression of so-called cancer evolution, upgrading, or progression. Clearly, relying on this inaccurate test to “manage” prostate cancer is a gigantic mistake.

“Fusion” MRI/ultrasound imaging for prostate biopsies.

Unlike the grossly unscientific 12-core random biopsy sampling 0.1 percent of  the prostate, the MRI is able to evaluate the whole prostate. The beauty of this process is that the MRI can ignore low-risk disease and eliminate a lot of needless and risky prostate biopsies. The non-contrast MRI of the prostate by an expert radiologist is the most reliable screening tool to detect the 10-15 percent of high-risk, potentially deadly prostate cancers that are responsible for the 30,000 or so deaths in the U.S. annually. Any areas suspicious for high-risk prostate cancer (PI-RADS 4 or 5 classification) can then be targeted with an MRI-guided needle biopsy for confirmation of disease. Nonetheless, not all prostate MRIs are equal. In fact, most MRI studies of the prostate are now conducted employing “fusion” studies. This fusion study is the product of a combination of an MRI and an ultrasound image. However, the process requires a number of steps that may increase the chance of mistakes. And, adding to these errors is the fact that not all MRI and ultrasound equipment, software, methodology, and physician’s interpretive skills are equal. Additionally, the MRI PI-RADS classification for prostate cancer, like the Gleason grading and scoring system, is complex and prone to errors of interpretation. Unsurprisingly, the jury is still out on the safety and benefits of this fusion study. If it targets and detects mostly the less common potentially deadly high-risk cancers it will be a winner. But, if the study is combined with the absurd random 12-core biopsy and detects mostly low-risk disease, this fusion study will be another loser in a long list of prostate cancer test failures.

Physician arrogance, medical injustices, and dereliction of duty. 

The fundamental role of physicians is a commitment to healing using the best of their ability, keeping patients from harm and injustice and being accountable to that commitment. In stunning contrast, the accepted practices of prostate cancer testing and treatment document a shocking lack of safety, a high degree of potential harm, and no scientific evidence for significant life-extension. 

PSA testing has a false positive rate of 78 percent and is highly unreliable (as are tests incorporating a PSA); PSA testing fails to save significant numbers of lives; the 12-core needle biopsy is risky and associated with an incredible sampling error; the Gleason 3+3=6 fails to behave as cancerous; the Gleason grading and scoring system is complex and associated with a significant incidence of interpretive errors by pathologists; prostate cancer surgical treatment fails to save significant numbers of lives and is associated with many positive margins and limp and leaking complications; the 10-year survival, whether treated or not, is about the same while the 15-year survival is about the same irrespective of the type of treatment. 

This disgraceful and unacceptable list of ineffective and harmful practices exposes the brazen intellectual dishonesty of urology leaders. Masquerading as “standard-of-care,” this medical injustice of false hope and false promises has made a mockery of the AUA guidelines, the FDA regulatory machine and caused a public health disaster. 

What’s wrong with active surveillance for prostate cancer? Everything.

Active surveillance is a program where a risky, non-life-saving treatment is delayed while unreliable, potentially harmful tests are used to monitor your low-risk prostate cancer. A misguided program where undependable and unsafe medical practices are blended together in the hope of delivering something more reliable and safe. Unsurprisingly, there is no irrefutable and reproducible evidence of life-extension to support the continuation of these deceitful recommendations. Advice that simply represents another prescription for nonstop licensed medical malpractice in the prostate cancer arena. 

Read more - These books should be required reading for any patient or physician (particularly academic urologists and urology residents) entering the prostate cancer arena.

The Great Prostate Hoax by R. Ablin and R. Piana.

The Rise and Fall of the Prostate Cancer Scam by A. Horan M.D.

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From 'poster child' to 'problem child'?: Evolution of an AS patient

By Howard Wolinsky

I found Dr. Bert Vorstman’s essay above unsettling. What about you?

He rejects the PSA testing and Active Surveillance that have been the center of my care since I was diagnosed with very low-risk prostate cancer in December 2010.

Since then, I have heard from some of the top experts in the world that I probably would not even be diagnosed with prostate cancer these days with the use of MRI scanning.

Others—unlike Vorstman—say I should continue PSA testing but steer clear of MRIs and biopsies unless my PSAs start rising rapidly. That’s the approach I have taken—with the approval of my urologist—since 2017.

Dr. E. David Crawford, of the University of California, San Diego, a prostate testing guru, told me too many patients like me are on AS. He said his fellow urologists should be looking for serious cancers, not for patients to put on AS. He favors routine testing of PSAs without explicit patient approval to find dangerous prostate cancers.

AS is evolving. It’s not the same as in 2010 when MRI scans were just being introduced. It’s not the same from five years ago when geonomics was catching on.

Today, AI (artificial intelligence) and Polygenic Risk Scores (PRS) seem like buzzwords. But AI diagnostics has its food in the door. Loads of studies on PRS are in the publication pipeline.

As it is, urologists take different approaches to AS, with different intervals for PSAs, MRIs and biopsies.

In 2017, I was invited to be the first patient to speak to the American Society for Clinical Oncology Genitourinary Cancer Symposium. Dr. Freddie Hamdy, a leader in the ProtecT trial and Head of the Nuffield Department of Surgical Sciences at the University of Oxford, sat next to me on the stage, He told me he believded AS had a future but not for patients like me. He said AS should mainly be for men with favorable intermediate-risk Gleason 3+4, who need to be monitored.

Crawford in essence told me I was part of the problem, not the solution.

It was very deflating. I went from hero in my mind—a conscientious objector to the War on Cancer—to zero, someone who should never have been diagnosed to begin with. In a decade-plus, went from “poster boy for AS” in the eyes of my UChicago urologist to AS “problem child.”

I understand the message, but I still believe AS was the best strategy for me back in 2010 and that it makes sense now for those who have gotten on the biopsy bus and been diagnosed to stay on AS.

I still think AS saved me. Once you get tagged as a cancer patient, you can’t unring the bell unless you seek treatment.

Thirteen years later, even the doctor who in 2010 tried to rush me into his OR has patients on AS. It’s a sign of the evolution of urology practice—with more data to support AS and patients pushing for change.

Only 6-10% of us with low-risk disease in 2010 went on AS. Now it’s 60% in the U.S., saving thousands of prostates per year. But this still lags behind 90%+ uptake in Sweden, UK and Michigan.

My personal AS program also has evolved over time. I used to have several PSAs per year and an annual biopsy. I now have a PSA once a year. I haven’t had a MRI or biopsy in six years. AS, like auto mileage, varies.

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I asked Dr. Vorstman some questions.

HW: Should men just skip PSAs? 

Dr. Bert Vorstman: The PSA has a false positive of 78% and detects mostly low-risk disease.

[He added these observations:]

—Low-risk disease grows incredibly slowly.

—Urologists' own studies concluded that PSA testing fails to save significant numbers of lives.

—Where is the irrefutable and reproducible scientific evidence that we are saving significant numbers of lives for those with high-risk disease?

—There's no evidence that surgery (open or robotic) saves significant numbers of lives.

—The PSA simply steers men to risky and grossly unscientific hit-or-miss biopsies that are read by pathologists prone to errors of interpretation.

HW: Should men skip PSAs?

BV: Absolutely.

HW: Should they not go on AS?

BV: Yes. Stop PSA testing and active surveillance.

There is no irrefutable and reproducible scientific evidence for safety or benefits - we're not saving significant numbers of lives

It's hard for a physician to say - sorry, we made a mistake

Sadly, the history of medicine has recorded numerous examples of bad practices - even now it's estimated that a large percentage of so-called standard practices are without merit and a danger to health

We need to find a blood or urine marker that can detect the 10-15% high-risk prostate cancers early - before cells have spread into the marrow and find a treatment that actually is safe and saves significant numbers of lives.

We have to stop health robbery and be honest - stop the medical injustices.

………

Vorstman is a uro-heretic. I welcome his opinions. But I personally approach this cautiously and urge you to do the same. Don’t make any changes without a serious heart-to-heart with your own urologist.

Would my life have been better had I never been diagnosed with very low-risk prostate cancer? No doubt. I would have avoided a few anxious moments and would not have been branded an life insurance paraiah.

When I had my first PSA tests and biopsies, I naively believed I would not be diagnosed. I had danced between the raindrops up to that point in my life—age 63 then. My assumptions were wrong.

By the sheer luck of being the medical editor of a major metro newspaper, I found out about AS. I first saw a urologist who was pushing me to undergo a prostatectomy. In those days 90%+ of men like me underwent potentially life-changing aggressive treatments.

AS was my best option then. I’m sticking with my customized version of AS for now.

Breaking news: MUSIC wins ASPI award for AS advocacy

By Howard Wolinsky

On Friday, June 16, in Grand Rapids, Michigan, representing Active Surveillance Patients International (ASPI), I presented an award to the MUSIC (Michigan Urological Surgical Improvement Coalition).

(From left, Dr. Arvin George and DR. Kevin Ginsburg, co-directors of MUSIC’s prostate cancer program, Howard Wolinsky for ASPI, and Dr. Khurshid Ridwan Ghani, director of the Michigan Urological Surgery Improvement Collaborative.)

MUSIC has demonstrated in the state of Michigan how more than 90% of patients with low-risk prostate cancer can go on active surveillance and avoid more aggressive treatments with serious adverse effects. The national average is only 60%.

Kevin Ginsburg, MD, a prostate cancer leader at MUSIC and a urologic oncologist at Wayne State University, said: “We (MUSIC) are honored and thrilled to receive this award. Improving patients’ lives and patients are at the foundation of our efforts. Receiving this award from ASPI, a patient advocacy group, makes the award even more special!”

The ASPI Special Award is an original painting by Kathy Lockwood symbolizing how patients and physicians can work together to “First, Do No Harm,” (Hippocrates), and preserve patients' quality of life.

I congratulated MUSIC, funded by Blue Cross Blue Shield of Michigan, for advancing the cause of AS. But I also challenged MUSIC to find ways to keep patients on AS. About 50% of patients who go on AS drop out within five years of diagnosis.

Mark Lichty, chairman of ASPI, who could not attend the award presentation, said: “MUSIC has shown what can be accomplished in all types of urology practices, from academic to large and small private practices. It should be the model for the entire country.”

More on the award here. And more to come.

The ASPI Awards Committee soon will announce its second Chodak Award for physician pioneers in AS. Dr. Laurence Klotz, of the University of Toronto, was the first recipient in 2022.

ASPI on July 1: ‘Pissed Off: The Many Ways Urination Can Go Wrong’

By Howard Wolinsky

Dean Elterman, MD, an academic urologist at the University of Toronto, is presenting a free webinar, “Pissed Off: The Many Ways Urination Can Go Wrong” to Active Surveillance Patients International at 12-1:30 p.m. Eastern on July 1, 2021.

Click here to register: https://tinyurl.com/5d7ypd8k

He’ll cover the waterfront of topics, from BPH to incontinence to overactive bladder.

The session will be followed with a live Q&A.

(Dean Elterman, MD, University of Toronto.)

Elterman’s research interests include voiding dysfunction, benign prostate enlargement, and men’s health.

He is the medical director of the Prostate Cancer Rehabilitation Clinic at Princess Margaret Cancer Centre in Toronto.

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