What's The Truth About Prostate Cancer?

Is the cure worse than the disease?

(Editor’s note: Dr. Bert Vorstman and author/investigative reporter Ron Piana like to, as Dr. B. says, “to rattle the cages.” They’ve written three of the top 10 most-read articles that have appeared in The Active Surveillor over the past three years. They’re back again here with this commentary on prostate cancer in the aftermath of the case of President Joe Biden and his Gleason 9 (Great Group 5) cancer.

(I call Dr. Vorstman, the “uro-heretic” because of his stands on his profession. He’s teaming up with Ron Piana, co-author with Richard Ablin, PhD, of “The Great Prostate Hoax: How Big Medicine Hijacked the PSA Test and Caused a Public Health Disaster,” the expose of the approval of the PSA blood test. Buckle up, and be prepared for a wild ride. If you disagree with Vorstman and Piana, please comment, but let’s be civil. Warning: The authors present controversial views. Discuss them with your personal physicians. Also, I am happy to print rebuttals.—Howard Wolinsky)

By Bert Vorstman MD, Ron Piana

What is the truth about prostate cancer? The recent media kerfuffle about Joe Biden's prostate cancer diagnosis and whether or not he had his PSA tested simply spotlights the many controversies that have poisoned the prostate cancer narrative with misleading information.

Given that only about 11 percent of medical treatments have proven benefit, most published medical research is false and healthcare is largely financially driven; it raises serious concerns about the dependability of prostate cancer recommendations. Guidelines for prostate cancer screening and treatment that the prostate cancer industry passionately upholds to be standard-of-care and life-saving but supported by hazy and contradictory evidence.

The marketing claims about prostate cancer.

Claims about the so-called benefits of prostate cancer detection and treatment have been widely promoted by the urological community. Postings such as, get screened before it’s too late; get checked every few months; early detection allows early treatment; early detection can lead to less aggressive treatments; early detection may lead to improved survival; get treated before it spreads; treatments are supported by “clinical studies”; FDA-approved; follows medical guidelines; standard practice; standard of care; gold standard and endless other puffed-up one-liners.

But why does the prostate cancer industry heavily market prostate cancer screening when most prostate cancers are outlived and the treatments are commonly worse than the disease itself?

What is prostate cancer?

Prostate cancer is a disease where prostatic cells have become abnormal, divide uncontrollably, have the ability to invade locally and possibly spread to other parts of the body to potentially cause death. However, the vast majority of prostate cancers do not cause death.

(Bert Vorstman, MD, (top) and author Ron Piana.)

The Gleason classification system.

Prostate cancer typically exhibits several patterns of growth when viewed under low-power microscopy. [Dr. Donald] Gleason chose the two most common patterns of growth seen on a slide and grade each of these two patterns of growth from 1 to 5 with 5 being the most disorganized and aggressive. He then added these two Gleason grades for a Gleason score. For example, if the first most common pattern was judged to be a grade 3 and the second most common pattern was also judged to be a grade 3, then 3+3 = 6 or a Gleason score of 6.

Advantages and disadvantages of the Gleason grading/scoring system.

Advantage of the Gleason grading/scoring system.

To better predict the behavior of the prostate cancer (adenocarcinoma) detected.

Disadvantages of the Gleason grading/scoring system.

The Gleason classification system is complex and dependent upon the knowledge and subjective judgment of the pathologist. Errors of interpretation are possible; studies have shown that grade misclassifications and disagreements between pathologists are common; multiple pathologists can deliver a different diagnosis for the same biopsy; even the same pathologist reading the same slides at another time may offer a different diagnosis; the Gleason score fails to accurately predict the clinical behavior of the particular cancer detected; the diagnosis may not represent the true state of affairs existing within the prostate because less than 1 percent of prostate tissue is sampled with the needle biopsy and most prostate cancers are multifocal.

Multifocal nature of prostate cancer.

Prostate cancer is multifocal (two or more independent lesions) in about 80 to 90 percent of cases. This means that several distinct tumor areas can exist within the prostate gland rather than as a single isolated tumor. Although it was believed at one time that the biggest lesion or so-called index lesion harbored the most aggressive grade of cancer, this has been shown not to be true. Typically, the growths in the prostate vary in size, are genetically distinct and exhibit varying rates of progression.

That is, of different Gleason grades and scores or aggressiveness. Rarely, two independent cell lines/Gleason grades can exist within the same tumor. And, rather than a new higher grade cancer being due to an upgrading of an existing Gleason grade (there’s no evidence that it can), upgrading refers to the development and detection of a new independent higher grade disease. And, more lesions may indicate a greater risk for the development of higher-grade disease in the future. A situation which is due to the phenomenon of field effects.

Field effects and prostate cancer.

Field effects or field cancerization is a scenario where tissue has been triggered by some unknown agent to become premalignant and cancerous at some point in the future. Field effects are responsible for the possible development of additional cancers of unpredictable grade in the future. A risk that may be greater for those with an increased number of prostatic lesions. In fact, the association of field cancerization with multifocal prostate cancer has significant implications for prostate cancer diagnoses, needle biopsies, focal therapy and recurrence.

Are all prostate cancers equal?

No, not all prostate cancers (or prostate cancer diagnoses) are the same or equal. The problem with the all-inclusive prostate cancer label is that it gives one the impression that all prostate cancers are alike and that all are potentially life-threatening. In contrast, most prostate cancers are outlived because they tend to grow sluggishly taking 479 +/- 56 days for cell division. This rate of cell division means that it can take 40 years or more from original mutation for the cancerous growth to reach about one centimeter (half an inch) in diameter.

The Gleason 3+3=6 lacks the hallmarks of cancer.

Years ago, the grade 3 cell within the Gleason 6 was labeled as a cancer purely on the basis of its low-power microscopic appearance. A mischaracterization that caused (and still causes) the overtreatment and life-altering side-effects in countless unwitting men.

In contrast, despite the grade 3 exhibiting some minor biochemical features (which can be exhibited in benign cells) and some ability for perineural invasion (the ability to occupy the small spaces surrounding the tiny nerves within the prostate and which can be exhibited in non cancers), the molecular pathways for cancer development and spread in the grade 3 cell are inactive. Therefore, because the grade 3 within the Gleason 6 lacks the genetic features to behave as cancerous, the grade 3 cell within the Gleason 6 is a false cancer.

There are a number of troubling clinical scenarios that result from the failure of urologists to address the fact that the grade 3 (as in the Gleason 3+3 = 6) is a false cancer. Urologists can continue to promote fear and doubt; patients will continue to be exploited and suffer from emotional distress, unnecessary treatments, physical harm and financial burdens; prostate cancer support groups can continue to recycle misinformation to get funding; prostate cancer statistics will remain inflated and the life insurance industry can terminate or deny the life policies of individuals misdiagnosed with cancer.

This exposure to falsehoods and health dangers underscores a gigantic failure of physicians and the American regulatory apparatus (such as the FDA) to protect patients from harm and injustice. Wrongs where public health has been swindled to the tune of $12.6B by those with financial conflicts of interest in the business of prostate cancer.

Which prostate cancers are potentially deadly?

Essentially, it’s the 10 to 15 percent of high-grade prostate cancers that are responsible for the 30,000 or so U.S. deaths annually. Increasing age is associated with an increased incidence of prostate cancer, a greater incidence of higher grade cancer and a more advanced presentation. And, certain inherited gene mutations such as the BRCA 1/2 (especially BRCA 2) carriers and African-American men may have a greater risk of developing high-grade, aggressive cancer. These high-grade and metastatic prostate cancers tend to have much quicker growth rates and may explain why these particular men are more likely to die of prostate cancer.

Are prostate cancer statistics believable?

Prostate cancer is extremely common, mostly silent and mostly outlived. In fact, the prevalence of autopsy-detected prostate cancer is about 21 percent across all ages and these cancers are typically small in volume, low-grade and without symptoms.

Regrettably, the frequency of this cancer is exploited through the marketing of fear-based statistics such as 1 in 8 men will be diagnosed with prostate cancer in their lifetime and that it's the second leading cause of death in men after lung cancer.

However, the fact that prostate cancer statistics include the false Gleason 6 cancer as well as mostly sluggish growing low-grade cancers that are outlived, inflates and exaggerates the incidence of meaningful prostate cancer.

Aside from the concerns about overblown prostate cancer statistics, the information delivered by the vast majority of prostate cancer treatment studies is also troubling: inclusion of subjects with the bogus Gleason 6 cancer; participants with sluggish- growing low- and intermediate-risk cancers as well as the comingling of patients with various Gleason grades, Gleason scores and tumor volumes. And, departing completely from sound scientific methodology so as to negate results, is the arbitrary use of testosterone suppression or androgen deprivation therapy (ADT) in certain participants - a treatment which itself can produce life extension. As well, because most prostate cancers grow sluggishly, studies with short five or ten-year follow-up periods will obviously be inconclusive. And, because most, if not all, prostate cancer treatment studies are founded on unsound scientific principles, claims of treatment success can be largely dismissed.

Screening for prostate cancer.

Prostate cancer screening uses primarily the digital rectal exam (DRE) and the PSA (prostate specific antigen) blood test for early detection of prostate cancer when supposedly it is readily treatable. However, in order for screening tests to be useful they should have high sensitivity and specificity, be safe and acceptable to patients, readily available, cost-effective, and be able to detect the disease in its early, asymptomatic stage in order to allow complication free treatment with scientific evidence for life extension. But, do prostate cancer screening tests meet these criteria?

The prostate exam.

The prostate exam or digital rectal exam (DRE) is highly unreliable. For this test the physician puts a gloved and lubricated finger into the rectum to judge whether the prostate feels normal or abnormal as some cancers are known to feel hard. Although this check takes only a moment, it can be uncomfortable or even painful for those who have an anal fissure, hemorrhoids, or who have some anal stenosis after hemorrhoid surgery.

And, because this exam depends on a judgment by the practitioner, different doctors will have different opinions about the feel of the same prostate. As well, prostate nodules need to be about 1 cm in size before being routinely detectable while abnormalities towards the front of the prostate (being further from the finger) are likely to go undetected unless significantly larger. And, conditions such as benign prostate nodules, chronic prostatitis, granulomatous prostatitis, tuberculous prostatitis and prostatic calculi or stones can also feel hard and mimic prostate cancer. As a result, not only is this exam unreliable and prone to observer error but, subjecting patients to yearly prostate exams to determine if any changes can be detected is clearly illogical when most prostate cancers take many years to get to 1 cm in size. Little wonder some physicians are abandoning the DRE.

The PSA test.

The PSA blood test is also highly unreliable. It has a 78 percent false positive rate; it can fluctuate throughout the day, day by day and from lab to lab because they use assays calibrated differently; the specific label for the prostate specific antigen is a bare-faced lie as the test is not specific for the prostate or for prostate cancer; it's so-called limits of 0 to 4 ng/ml as being normal are made up and meaningless; most PSAs are raised because of BPH or benign enlargement of the prostate - big prostates generate “big” PSAs; the PSA tends to rise with age because the prostate tends to enlarge with age; most screen-detected prostate cancers are discovered because the PSA was elevated by the benign prostatic enlargement and not the cancer; the PSA is easily raised by numerous benign processes (such as sexual activity, prostatitis, urinary tract infection, prostate exam, cystoscopy, recent biopsy, catheter and so on); an elevated PSA doesn't mean you have prostate cancer; a normal PSA doesn't mean you don't have prostate cancer; the lowering of a PSA doesn't mean you have less or no cancer - the PSA is lowered by various drugs such as 5 alpha reductase medications, statins and thiazide diuretics; the PSA cannot distinguish between aggressive and non-aggressive cancers; and, not only are PSA levels not reliable indicators of tumor volume but some potentially deadly high-grade prostate cancers may produce little or no PSA and go undetected.

Does PSA-based testing save significant numbers of lives?

Not only do the DRE and PSA tests fail to meet the criteria necessary to be effective screening markers but, urologists' own studies have determined that PSA testing failed to save significant numbers of lives. This fact has been confirmed by others. Yet, despite the PSA test being highly unreliable, failing to meet the criteria of an effective screening tool and failing to save significant numbers of lives, the urology community labeled the study as standard of care and even helped engineer an FDA approval for the test in 1994. An approval that was a gigantic healthcare misstep in men’s health since so-called elevations of this PSA test invariably leads to more risky testing, unnecessary procedures and is without scientifically proven evidence for delivering life extension.

There are many other prostate cancer markers promoted as being useful. PSA derivatives such as the free PSA, percent free PSA; the Prostate Health Index (PHI); PSA density; PSA velocity/kinetics/PSA doubling time; age-related PSA levels; pro PSA; PCA3; PTEN genome test; urine markers; indexes; scores; spit tests and others.

These tests are commonly recommended to better understand the biopsy results and try to prevent over-testing and over-treatment of slow-growing low-grade cancers. However, there's no evidence that any of these markers, scores and indexes are accurate enough to estimate which prostate cancers are potentially deadly or may become deadly so as to alter care. As well, like the PSA test, there’s no scientific evidence that these other prostate cancer markers save significant numbers of lives.

Advantages and disadvantages of prostate cancer screening.

Urinary and sexual symptoms are not early warning signs of prostate cancer. Instead, urinary symptoms are due to benign enlargement of the prostate which is a normal part of aging as is waning sexual function.

Advantages of prostate cancer screening.

Early detection may allow earlier treatment which may reduce the risk of cancer spreading; knowing your status may be reassuring and may help reduce anxiety.

Disadvantages of prostate cancer screening.

The DRE and PSA screening tests are highly unreliable; both the DRE and PSA test fail to meet the criteria for being useful screening tests; the false positive rate for the PSA test is approximately 78 percent; high-grade cancers may produce little or no PSA and be missed; both the DRE and PSA tests are without scientific evidence for life extension; instead, abnormalities with the DRE and PSA tests invariably lead subjects to risky and undependable prostate needle biopsies.

What is prostate cancer detection?

Prostate cancer detection is the act of discovering cancer(s) using imaging, needle biopsy, pathological studies (the advantages and disadvantages of pathological studies using the Gleason grading and scoring system for prostate cancer were discussed earlier in this article) and staging techniques to determine if the cancer is localized to the prostate.

Prostate cancer imaging.

Non-contrast multi-parametric magnetic resonance imaging (mpMRI) of the prostate is the most reliable way to screen for and detect infrequent, significant potentially life-threatening types of prostate cancer. If a biopsy has already been performed the MRI should be delayed several weeks to let the inflammation associated with the tissue sampling settle so as to prevent imaging defects.

Advantages and disadvantages of prostate imaging.

Advantages of the non-contrast mpMRI of the prostate.

The mpMRI is now considered standard-of-care and the best screening and detection tool for high-risk, high-grade prostate cancer. It's a fairly reliable test but only with the right equipment and with experienced radiologists; gadolinium contrast has slight toxicity concerns and is not usually needed; the whole of the prostate can be evaluated; low-risk cancers can be ignored so that these cancers are not over-diagnosed and over-treated; high-risk/high-grade areas seen on the mpMRI are classified as PI-RADS 4 or 5 changes; mpMRIs are generally safe for patients with hip prostheses, penile implants, defibrillators and pacemakers but may need expertise to interpret.

Disadvantages of the non-contrast mpMRI of the prostate.

Not all MRI machines and software are equal and not all radiologists have sufficient knowledge to ensure that the technique followed is appropriate and or, have the experience to interpret the images successfully; images may be under read or over read to deliver false negatives and false positives; metal hardware in the body can make images difficult to interpret; although the mpMRI has a high sensitivity for detection of significant prostate cancer some studies have shown that a considerable number of clinically important lesions can be missed by radiologists; lesions need to be at some 5 - 10 mm in diameter before being consistently detectable; 5 - 10 mm is also about the size that can be accurately targeted for MRI-guided needle biopsy; granulomatous prostatitis can mimic prostate cancer; some high-grade prostate cancers may already be metastatic when only about 2 mm in size and likely undetectable on MRI.

Micro-ultrasound imaging.

Micro-ultrasound (microUS) is a high-resolution ultrasound technique.

Advantages and disadvantages of micro-ultrasound imaging.

Advantages of micro-ultrasound imaging of the prostate.

Cost effective; no “tube claustrophobia”; metal implants are not a problem; offers high resolution down to about 0.2 mm.

Disadvantages of prostate micro-ultrasound.

Limited view of anterior gland; visualization lacks functional imaging capability; observer error and interobserver variability; inability to reliably target small lesions for biopsy.

Prostate tissue sampling/tissue acquisition/needle biopsy.

There are several prostate needle biopsy approaches and in descending order of reliability are; the MRI-guided targeted biopsy, the fusion biopsy and the ultrasound-guided 12-core prostate needle biopsy - whether transrectal or transperineally.

Advantages and disadvantages of the prostate needle biopsy.

Advantage of the prostate needle biopsy.

Enables prostate tissue to be sampled.

Disadvantages of the prostate needle biopsy.

Generally, for all prostate needle biopsy techniques, some areas of the prostate may be more difficult to access with the needle - particularly the anterior and apical regions of the prostate; only a small volume of tissue is acquired with each needle biopsy; some high-grade prostate cancers may already be metastatic before being detectable on imaging.

For the MRI-targeted biopsy - the lesion needs to be about 5 - 10 mm or so before it can be reliably targeted.

For the MRI-fusion prostate biopsy - many prostate biopsies are now done in the urologist’s office using an MRI fusion technique - a method where an MRI taken elsewhere at a previous time and of unknown quality is fused with the in-office ultrasound image taken with the trans-rectal probe.

However, the fusion technique has several disadvantages for detecting significant prostate cancer. It requires a number of steps and two different imaging techniques; there’s a lack of standardization for the process; patient discomfort is not uncommon; the ability and knowledge of the doctor to evaluate the imaging may be problematic; the target area needs to be large enough to be detected; surgeons need to be able to identify high-grade areas and have the skills to navigate the needle into the target area for biopsy.

For the ultrasound-guided prostate needle biopsy - this hit or miss biopsy technique is embarrassingly unscientific as it’s associated with a massive sampling error - when the volume of 12 needle biopsy cores is measured against an average sized prostate, only about 0.1 percent of the prostate is sampled. This leaves the doctor in the dark about the status of the 99.9 percent rest of the prostate.

And, since most prostate cancers are multifocal and not similar in size or grade, this needle sampling of minute amounts of prostate tissue can easily miss areas of significant cancer. An error that can readily explain the subsequent “appearance” of cancer upgrading or cancer progression. Additionally, the trans-rectal technique (when compared to the trans-perineal approach) is associated with significant potential septic events (sometimes needing hospitalization) and bleeding risks (sometimes requiring sigmoidoscopy to clip a bleeder). Other complications such as blood in the semen and erectile dysfunction are also common side effects of prostate needle biopsy.

Staging techniques for prostate cancer.

Imaging studies (and rarely, lymph node sampling) are used to stage or attempt to determine the extent of the prostate cancer diagnosed.

Advantages and disadvantages of prostate cancer staging.

Advantages of prostate cancer staging.

May determine if a prostate cancer is localized or has spread outside of the prostate.

Disadvantages of prostate cancer staging.

Staging is highly unreliable when using CT and bone scans as they are both relatively insensitive for detecting low-volume cancer spread; although more reliable, whole body MRIs to detect bony spread and PSMA PET–CT scans to detect soft tissue spread are also not foolproof as lesions need to be big enough to be detectable; some prostate cancers do not express PSMA leading to false negatives while other cancers and non-cancers can express PSMA leading to false positive scans; some high-grade prostate cancers may have already spread to the bone marrow before being big enough to be seen on imaging.

In fact, bone marrow aspiration studies using sophisticated staining techniques have identified cancer cells in the marrow of some whose high-grade prostate cancer was believed to be localized. These metastatic prostate cancer cells can lie dormant in the bone marrow for many years before some activate and spread to other parts of the body. This fact is the likely explanation for a semblance of cure after a prostate cancer treatment and the appearance of a biochemical recurrence (a rising PSA caused by residual prostate cancer cells but without imaging evidence for spread) or frank metastases years later. And, whether or not circulating tumor cells associated with specimen manipulation during radical prostatectomy can result in a seeding of the bone marrow is unclear.

Prostate cancer treatments.

Prostate cancer treatments include whole gland treatments using surgery (open or robotic assisted) or radiation (external beam, seeds/brachytherapy and proton beam); focal therapy options using cryoablation, high-intensity focused ultrasound (HIFU), laser and photodynamic therapy (PDT). Other options such as androgen deprivation therapy (ADT) or testosterone suppression, chemotherapy and so-called immunotherapy with agents such as Provenge are used to “control” advanced or metastatic disease. Treatment choices depend on the grade and score of the prostate cancer, stage, comorbidities and the patient’s age at the time of diagnosis.

The goal of focal treatments was to avoid the many potential complications associated with whole gland treatments. And, it was predicated on the belief that although prostate cancer was a multifocal disease, there was usually one main or index lesion (the bigger/dominant growth) and if only this area was treated that control or “cure” could be possible. However, recurrent disease was common after focal therapy as the index lesion did not always contain the highest grade cancer. As well as tumor recurrence, focal therapy is associated with other potential complications such as rectal fistula, urethral stricture, urinary incontinence and other urinary and sexual downsides.

Prostate cancer surgery.

In 1904, Dr. H. H. Young from Johns Hopkins published his paper, “The Early Diagnosis and Radical Cure of Carcinoma of the Prostate.” Not only was there zero evidence in his paper for early diagnosis and radical cure but there was no evidence to support his claims about the procedure’s “simplicity, effectiveness and remarkably satisfactory functional results furnished.”

In contrast, two patients died and two patients were left totally incontinent of urine after prolonged hospital stays. Yet, despite these horrific results and a lack of evidence for life extension, some urologists believed that radical surgery could be curative and continued with more trial and error human experimentation to “optimize” the procedure. Exploring techniques to better control surgical bleeding and urinary incontinence, nerve-sparing modifications to decrease the post-operative incidence of erectile dysfunction and salvage surgery methods for those who had failed radiation treatment.

Years later robotics entered the surgical treatment landscape. The device was first investigated in Mexico because the rules for experimental surgery were more relaxed. Accordingly, a lowlevel study was done comparing laparoscopic gallbladder surgery to robotic cholecystectomy.

Yet, despite the fact that robotic gallbladder surgery failed to show clear benefits over laparoscopic gallbladder surgery, the FDA (Food and Drug administration) approved the tool for robotic cholecystectomy in 1999 on the basis that the device “demonstrated potential for future enhancements to surgery.”

However, when it became evident that there was no market for robotic gallbladder surgery (the laparoscopic approach was easier) the device company searched for a new disease to use their robotic tool.

Eventually, urologists were found who still believed that cutting out prostate cancer was curative. Needing little persuasion, these doctors worked with the device company to leverage the FDA’s 510(k) process and obtain an FDA approval for use of the tool for robotic-assisted prostatectomy in 2001. Remarkably, this approval was achieved without any supporting scientific data that the robotic tool was safe and effective for radical prostate cancer surgery.

Prostate cancer treatment complications.

Unsurprisingly, because there was no scientific data proving that radical prostatectomy was safe and effective, prostate cancer surgery is associated with many potential complications - many of which will also require treatment. Predictably, the FDA’s MAUDE (Manufacturer and User Facility Device Experience) division recorded a significant uptick in complications associated with the robotic prostatectomy. Yet, despite the many complications and the lack of scientific evidence for safety and benefits, physicians still gave robotic prostatectomy the stamp of standard-of-care.

The many complications associated with both open and robotic prostatectomy include; incomplete cancer removal or positive margins in 11 to 48 percent of patients; a biochemical recurrence (rising PSA after treatment and due to remaining prostate cancer cells somewhere) in 20 to 40 percent of patients within 10 years of treatment. Many of these patients with residual cancer will be treated with radiation to the prostate bed - the benefit of radiation or postoperative radiation remains unclear and is controversial. As well, radiation is also associated with urinary, bowel, sexual complications and a small incidence of second cancers. Alternatively, some patients will be treated with ADT which itself may extend life by slowing the doubling-time of high-grade and metastatic prostate cancer cells. But, ADT is also associated with several potentially significant side effects such as fatigue, hot flashes, hair loss, breast enlargement, impotence, mood swings, depression, bone marrow suppression and others. Additionally, the benefits of ADT are not indefinite as invariably, treatment resistant cells will emerge, progress and take over.

Prostate cancer surgery is associated with numerous potentially debilitating complications such as rectal tears, lymphoceles, anastomotic leaks, infection, bleeding, blood clots and depression. Then there’s the loss of libido and manhood, incomplete or total loss of erections, lack of emission, lack of ejaculation or ejaculating urine, pain on orgasm, infertility, shortened penis, penile pain, penile numbness, penile wasting, penile curvature and testicular pain. As well, there’s urinary leakage, bladder neck scarring, bladder stones and urinary tract infections. And, because the prostate is intimately connected to erectile and bladder function, it's not surprising limp and leaking complications are common after prostate cancer surgery. Treatment options are many and varied. For erectile dysfunction, medications, suction or vibration devices, penile shockwave, penile injections or penile implants. Treatment choices for urinary leakage include pads, penile clamps, catheters, pelvic floor exercises, medications, biofeedback, bulking injections, slings, electrical stimulation devices or artificial sphincters. Regretfully, many of these attempts to fix limp and leaking problems will fail and require retreatment at extra expense and time. The end result is a very depressing healthcare journey that impacts both the patient and their loved one.

Do prostate cancer treatments save lives?

Although prostate cancer treatments are associated with numerous significant potential complications, do the treatments save significant numbers of lives? Amazingly, urologists’ own studies have concluded that at 12 years, 15 years and almost 20 years, radical prostate cancer surgery failed to save significant numbers of lives and had the same outcome as observation. As well, the study at 15 years showed that whether patients had no treatment, surgery or radiation, the three groups had similar survival rates. In other words, both treated groups and nontreated groups had similar survival rates. However, those that were untreated did not have any of the complications and diminished quality of life issues commonly associated with prostate cancer treatments. As well, there is no irrefutable and reproducible evidence that any other treatments such as brachytherapy, proton beam and focal therapy or combination treatments such as radiation plus ADT, deliver significant life extension.

A semblance of cure after treatment?

High-risk/high-grade prostate cancer is responsible for about 30,000 or so deaths of American men each year. Although the death rate from prostate cancer seems to have fallen somewhat in recent years, this hint of improvement is not likely due to treatments as 20-year data have concluded that neither surgery nor radiation save significant numbers of lives. More likely explanations for a slight fall in the death rate from prostate cancer are the continuing over-detection and over-treatment of sluggish growing low-risk and intermediate-risk cancers and, the better treatment of comorbidities such as diabetes and heart disease allowing patients to live longer. Obviously, these factors will skew “survival” figures after treatment to allow a semblance of benefit and cure.

Advantages and disadvantages of prostate cancer treatment.

Advantages of prostate cancer treatment.

Possibly control the cancer.

Disadvantages of prostate cancer treatments.

High incidence of potential complications; high incidence of positive margins after surgery; high incidence of biochemical recurrence; high incidence of secondary treatments to treat complications resulting from the initial prostate cancer treatment; lack of scientific evidence for significant life extension or cure.

Managing patient expectations after prostate cancer treatment.

The fact that prostate cancer treatments are associated with many potential complications have compelled physicians to develop strategies for managing patient expectations. Tactics that include informed consent and shared decision-making with in-depth discussions about potential treatment outcomes to gauge patient preferences and risk tolerances. And, to bolster these programs further, urologists employed preoperative and postoperative counseling and rehabilitation agendas to prepare patients for dealing with likely post-treatment limp and leaking complications. Yet, despite these various drills, treatment failures and patient regret levels remained high.

What is active surveillance?

Active surveillance (AS) is a management strategy whereby non-aggressive prostate cancer is monitored rather than being treated immediately. Although some progression of existing disease is possible, there’s no data-based scientific evidence that one grade of cancer can upgrade to another. Instead, AS is more about monitoring the multifocal nature of prostate cancer and the low possibility of developing a new higher-grade cancer at some time in the future. Typically, AS is recommended for men with low-grade and low intermediate-grade localized prostate cancer because, most prostate cancers grow sluggishly; most prostate cancers are outlived; prostate cancer treatments are often worse than the disease itself; cancer progression or a new high-grade cancer can usually be detected in time for treatment.

Advantages and disadvantages of AS.

Advantages of AS.

To avoid over-treatment and treatment complications.

Disadvantages of AS.

AS is not foolproof as, some high-grade cancers may have already spread before being detected because some high-grade prostate cancers make a little or no PSA; PSA testing fails to save significant numbers of lives; lesions need to be some 5 - 10 mm or so in size before being detectable on MRI; some high-grade cancers may already be metastatic when the growth in the prostate is as small as about 2 mm in size and undetectable on MRI; lesions smaller than about 10 mm or so cannot be reliably biopsied; frequency of surveillance testing to be beneficial is unknown; prostate needle biopsies are invasive, unreliable and risky; benefit of random prostate needle biopsies is unproven; there’s no irrefutable and reproducible evidence that any prostate cancer treatment saves significant numbers of lives; there’s no scientific evidence that AS saves significant numbers of lives.

What is prostate cancer awareness?

Prostate cancer awareness month (Blue September - like Movember - growing a mustache in November to support men’s health) is a program that aggressively encourages PSA testing, early detection and treatment.

Advantages and disadvantages of prostate cancer awareness.

Advantage of prostate cancer awareness.

Having some knowledge about prostate cancer.

Disadvantages of prostate cancer awareness.

Anxiety because of scare tactics; most prostate cancers outlived; no scientific evidence that prostate exams and PSA testing achieve life extension; exposure to invasive testing, over testing and over treatment; exposure to testing and treatment complications; no scientific evidence that any prostate cancer treatment saves significant numbers of lives.

Reasons why high-risk prostate cancer can be missed.

Sometimes, despite so-called normal screening tests and stable active surveillance findings a patient will suddenly be diagnosed with metastatic prostate cancer. There are some reasons as to why this happens - despite the fact that most screening tests fail to meet the criteria for being useful.

Detection limits and reliability of prostate cancer tests.

Detection limits for prostate cancer screening and diagnostic tests refer to the lowest level or smallest tumor burden that a test can reliably detect. Different tests have different sensitivities and specificities and their detection limits vary based on the technology used. We've discussed many of these limits in the body of the report, but a quick summary is helpful.

The prostate exam has about the same reliability as a coin-toss; the PSA is not specific for the prostate or prostate cancer (there's no scientific evidence that any of the other biomarkers save significant numbers of lives); lesions need to be a certain size before being detectable on imaging (about 5mm) or on biopsy slides; imaging and pathological studies are dependent on practitioner knowledge and interpretative skills; inter-observer error is not uncommon; both imaging and pathology studies can be over read or under read; the ultrasound-guided prostate needle biopsy samples blindly and randomly only about 0.1 percent of the prostate to leave practitioners clueless about whether or not there’s significant cancer in the 99.9 percent rest of the prostate.

Amplifying these detection limits are a couple of other important factors. Eighty to 90 percent of all prostate cancers are multifocal. Now here’s the kicker. In multifocal prostate cancer, different tumor foci/lesions can have both similar and dissimilar grades and scores. While a significant portion of foci may share similar grades with the detected specimen, other foci can exhibit different grades and scores within the same prostate. How come?

As discussed earlier, prostate cancer is often impacted by field effects. This phenomenon, which can be genetic or epigenetic, can increase the risk of developing new, independent tumors within the same gland. This means that an initial diagnosis of a low-risk cancer may be subject to change over time and why active surveillance for low-risk cancers was proposed. However, neither PSA-based screening nor active surveillance are foolproof because some new high-grade areas of prostate cancer can produce little or no PSA and some particularly aggressive forms may already be metastatic to the bone marrow before detection or when barely detectable.

Blaming the USPSTF.

In 2012 the USPSTF (United States Preventive Services Task Force) gave PSA-based prostate cancer screening a “D” grade, recommending against the test for all men because “the benefits did not outweigh the harms.” In 2018 the USPSTF gave PSA testing a “C” grade a for men ages 55 to 69 and that it be individualized on the basis of an understanding of the possible harms and possible benefits - the test still has a “D” rating for men 70 years and over.

Recently, studies suggested that the rates of prostate cancer (particularly for those presenting with more advanced disease) was on the rise. This apparent increase in those presenting with more advanced prostate cancer was quickly blamed on the USPSTF ruling restricting PSA testing for men over 70 years of age. This accusation is clearly misguided because urologists' own studies have concluded that both PSA testing fails to save significant numbers of lives. On the other hand, the ballooning obesity rate and the finding of increased cancer rates in this group as well as other socio-economic reasons may be more credible explanations for the apparent increase in prostate cancer numbers and in those presenting with more advanced disease.

Can high-grade prostate cancer be prevented?

Currently, there are no scientifically proven methods to prevent potentially deadly high-risk prostate cancer and extend life. However, adopting healthy life-style habits may be helpful.

Doctored results, cover ups and licensed medical malpractice.

The evidence presented shows clearly that the current prostate cancer narrative promoted by physicians is nothing but a fear-based ideology of exaggerations, false hope and false promises. Instead, most prostate cancers are outlived; most prostate cancers are multifocal and impacted by field effects; PSA-based screening is highly unreliable; PSA testing fails to save significant numbers of lives; the Gleason 6 is a bogus cancer; cancer detection and pathological diagnoses are unreliable; some high-grade prostate cancers may already be metastatic by the time they are detectable on MRI; prostate cancer treatments are associated with a significant incidence of potentially debilitating complications; both surgery and radiation treatments fail to save significant numbers of lives and there’s no scientific evidence that active surveillance or prostate cancer awareness result in life extension. And, the few studies where urologists claimed benefits, their treatment conclusions can’t be defended because of poor study design and a lack of irrefutable and reproducible data.

Promoting unsafe and ineffective medical treatments as standard of care is not uncommon in the healthcare arena. At one time, the radical mastectomy was also marketed as a potential lifesaver. However, it was eventually abandoned from the treatment options list not because physicians suddenly connected with their creed for keeping patients from harm and injustice. Or, because government healthcare oversight agencies such as the Agency for Healthcare Research and Quality (AHRQ) suddenly became aware of their responsibilities for ensuring the quality, safety, efficiency, and effectiveness of healthcare practices. But, only because a new treatment had been developed for breast cancer. Sadly, until better tests and treatments become available for localized prostate cancer and both physicians and oversight agencies are made accountable for unsafe and ineffective practices, countless men will continue to be harmed by the PSA test and radical prostatectomy for no benefit. A healthcare disgrace made even worse because of the indirect adverse effects on the patient's wife or partner.

Required reading.

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

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

Bert Vorstman B.Sc, MD, MS, FAAP, FRACS, FACS

bert@HEALTHdrum.com

HEALTHdrum - and discover self care.

HEALTHdrum YouTube channel for more prostate cancer information.

Dedication. To Dr. Anthony Horan. One of the first urological surgeons to challenge the false prostate cancer narrative.

Tick-tock: Register for Saturday’s Q&A with uropathologist Dr. Jonathan Epste

By Howard Wolinsky

Join Dr. Jonathan Epstein May 31 noon to 1 p.m. Eastern for a Q&A . Ask what’s on your mind regarding low-risk prostate cancer.

Register in advance:

https://us02web.zoom.us/meeting/register/sazI-npeR3OdGWyRIrVRYg

Send any questions to The Active Surveillor: Howard.wolinsky@gmail.com

Try to keep the questions on point and applicable to the broad audience. We can’t offer personal medical advice.

If you can’t make it to the live event, register so you’ll be notified when the video is posted at The Active Surveillor YouTube channel.

(Dr. Jonathan Epstein)

Meanwhile, the video of Dr. Jonathan Epstein’s webinar for The Active Surveillor on May 17 has posted in The Active Surveillor’s YouTube channel:

Rave reviews came in on the program, where Dr. Epstein told us about Active Surveillance, cribriform and loads more. You can view the recording here

More than 2.4 thousand have viewed in the past week,

While you’re there, check out other videos posted in The Active Surveillor’s YouTube Channel. Please like and subscribe.

Dr. Epstein recently launched Advanced Uropathology of New York: Global Consultation Services in New York City after nearly 40 years on the faculty at Johns Hopkins University School of Medicine. Advanced Uropathology is affiliated with Integrated Medical Professionals, PLLC, (IMP) (https://www.imppllc.com/about-imp-2/), a subsidiary of Solaris Health.

You can reach Dr. Epstein at https://advanceduropathology.com/consultation/

Contact him directly at: jonathaniraepstein@gmail.com

Come to the ASPI webinar June 28: Cracking the Code on Pathology Reports—Helping Patients Navigate Medicalese to Get Better Health Results

Most patients have a hard time deciphering pathology reports they get after prostate biopsies. At the same time, many are puzzled with their Gleason score.

Cracking the code on pathology reports: Helping patients navigate medicalese and get better health results

Cathryn J. Lapedis, MD, MPH, a Clinical Assistant Professor of Pathology at Michigan Medicine in Ann Arbor, has found in her research that patient-centered reports can help patients understand the reports.

She will be the featured speaker at the ASPI webinar from noon to 1:30 p.m. on Saturday, June 28.

Please register for the meeting here.

Lapedis was the lead author of a recent study in JAMA that found a 93% comprehension of patient-centered pathology reports compared with 39% of those who read a report from the University of Michigan and 56% reading a pathology report from the Veterans Administration.

While 93% of participants who received the PCPR accurately identified that the report showed prostate cancer, only 39% of those who received the university report and 56% of those who received the VA report did so.

She also looked at how these patients interpreted Gleason scores: 84% reading specially prepared patient-centric reports understood their scores vs 48% for the university group and 40% for the VA group.

She has fellowship training in medical renal and gastrointestinal pathology. Her research centers on rethinking the way pathology results are communicated to patients and the healthcare system. She completed an in-depth analysis of key stakeholders’ attitudes towards patient-pathologist interactions, and is currently piloting early interventions in patient-centered pathology communications.

Please send questions in advance to: contactus@aspatients.org