Is the PSA reliable enough as a screening test to pick out only those few men who have the potentially lethal type of prostate cancer? Many people are questioning the validity of the PSA and its use as a reliable screening test. So let’s discuss what is known about the PSA.
The Prostatic Specific Antigen (PSA)
In order for a prostate cancer screening test to be of health benefit it should be both highly specific and, highly sensitive for detecting ONLY potentially lethal prostate cancers. However, the PSA is neither specific (it fails to detect just one tumor type – it is positive in some breast cancers and other conditions) and, is highly insensitive for detecting only significant prostate cancers.
Despite a standard FDA approval resting primarily on whether a device is “safe and effective”, the highly ineffective PSA and its 78 percent FALSE POSITIVE RATE was given an FDA approval in 1994. The high false positive rate is because the PSA leads to the detection of mainly benign and non-lethal prostate conditions and, commonly FAILS to lead to the detection of the 15 percent or so of important, potentially lethal high-grade prostate cancers.
The Rot in The PSA Story
The PSA was discovered by Ablin in 1970. Using transcripts of the minutes recorded during the FDA reviews (Immunology Devices Advisory Panel Meetings), Ablin and Piana (The Great Prostate Hoax) detailed a very misguided FDA approval process for the PSA. In fact, after this “approval”, the highly unreliable PSA was simply hijacked by the profiteering Prostate Cancer Industry and used to misdirect men towards unnecessary testing and unneeded treatments. This “early” cancer detection-to-treatment hoax using PSA-based screening commonly robbed men of their health, failed to save significant numbers of lives and, only caused a gigantic public health disaster.
The Highly Unreliable PSA
Although marketed as “potentially life-saving”, the PSA blood test is associated with a very high false positive rate; leads to the detection of mainly non-lethal diseases; is NOT cancer-specific; its limits of “normal” are artificial; is commonly NOT the same result on repeat studies as it fluctuates normally; can be artificially raised or lowered by several processes without a cancer being present; often rises with age as the prostate grows; is normally high with big prostates and, MOST IMPORTANTLY, commonly fails to indicate the 15 per cent or so of potentially lethal high-grade prostate cancers with significant amounts of pattern 4 and or, 5 disease as these cancers often make little or no PSA. Furthermore, should an elevated PSA lead to a significant prostate cancer being detected, the elevated PSA is commonly caused by the enlarged benign portion of the prostate and NOT the cancer.
When Prostate “Cancers” Are NOT Cancers
Undeniably, on both clinical and molecular biology grounds, the Gleason grade 3 as in the Gleason 3+3=6 “cancer” (Gleason 6 or, G6) LACKS the hallmarks of a cancer (L. Klotz MD). Underscoring the sluggish behavior of the G6 is the fact that the G6 cell has a very long doubling time of 475 +/- 56 days so that from mutation to a growth of about 1 cm (smaller than half an inch) in diameter takes some 40 years. Furthermore, about 50% of 50 year-old-men have unrecognized and asymptomatic areas of G6 disease in their prostate and, that this so-called cancer fails to evolve and harm men suggests strongly that the G6 is simply part of the aging process. Because of these findings, there is simply NO justification for continuing to call the Gleason 6 a cancer and, the prostate cancer label should be restricted to just high-grade prostate cancers.
The Tricky Prostate “Cancer” Label
The all-inclusive prostate cancer label leaves the public with the impression that all prostate cancers are potentially lethal. Unfortunately, this very deceptive generic prostate cancer label includes both the bogus Gleason 6 and real prostate cancers. Even worse, this confusion allows predatory urologists to game the cancer label and imply that pseudo-cancers like the Gleason 6 are real and use falsehoods and scare tactics to bully patients into unneeded treatments for profiteering. Easily done since the only thing these vulnerable patients hear is the terrorizing cancer word.
The Highly Unreliable DRE
The DRE (digital rectal exam) is a finger examination of the prostate that has the same accuracy as a coin-toss. Performing this feeble test every few months during so-called prostate cancer surveillance makes no scientific sense; can be very uncomfortable; is especially unreliable for detecting the potentially deadly 15% or so of high-grade cancers early and, the examination is open to errors of interpretation and concerns for, “feeling something”; sensing a “nodule” or, feeling “unevenness” (asymmetry, which is normal). Terms designed to create confusion and doubt and, push men towards unneeded but money-making evaluations.
The Highly Unreliable Ultrasound-Guided Prostate Needle Biopsy
The “standard” ultrasound-guided, 12-core needle biopsy of the prostate to try and detect prostate cancer is both unscientific and, highly unreliable. Not only is the trans-rectal ultrasound part of the study blind and unable to identify high-grade prostate cancer (nor is the 3D color doppler able to detect only high-grade cancer) but, despite the knowledge that prostate cancer often develops in more than one area of the prostate and or, at different times (not unlike bladder cancer), this blind needle biopsy “test” samples randomly only some 0.1% — 0.3% of the prostate to leave one absolutely uninformed about the 99% rest of the prostate — especially so for the anterior portion of the prostate. This highly inaccurate biopsy test is also responsible for all of the confusion related to so-called prostate cancer upgrading and progression.
X-Ray and Pathology Reports are NOT Foolproof
The belief that X-ray readings, biopsy and pathology reports are accurate and foolproof is simply not true. Your biopsy specimens are read by a pathologist who, like his/her radiology colleagues reviewing imaging (X-ray) studies – and, any other physician having to make a judgement call – can make incorrect diagnoses because of inadequate knowledge and or, because of errors-of-interpretation. This is especially so for diagnosing prostate cancer because of the complexity of the Gleason grading and scoring system. Here, pathologists have to judge tumor aggressiveness based upon growth pattern appearances under the microscope and then combine estimates of the two most common patterns of growth seen (each arbitrarily graded 1-5 with 5 being the most aggressive) on the slide for a Gleason score. Since the biopsy reading is very dependent upon the individual ability of the doctor, incorrect judgements of cancer grade, Gleason score, cancer amount (volume), core length and or, whether a cancer is even present, are possible. Furthermore, although other background findings such as atypical small cell acinar proliferation (ASAP), high-grade prostatic intraepithelial neoplasia (HGPIN) and perineural invasion are often recorded, by far the most important feature of the biopsy report is whether or not significant amounts of high-grade (4s and 5s) prostate cancer have been identified as these cancers can benefit from treatment. But, because of possible errors-of-interpretation, getting prostate biopsy findings confirmed by a recognized leader in prostate cancer pathology is recommended highly.
The Best Prostate Cancer Screening and Detection Tool is the 3T MRI
To date, the newer versions (versions 3–5) of the 3T MRI (but only in the right hands) are the most reliable (almost foolproof) devices for screening and detecting the 15% or so of potentially deadly high-grade prostate cancers. Unlike the current “standard” screening and detection methods, the 3T MRI evaluates the WHOLE of the prostate, can ignore the bogus G6 cancer and, based upon imaging details in a properly conducted study, able to identify reliably with PIRADS 4 and 5 features, almost all high-grade cancer anywhere within the prostate. Any high-grade areas identified can then be targeted for needle biopsy under real-time 3T MRI for confirmation of disease as only these particular prostate cancers demand detection and treatment. However, because imaging studies are highly insensitive and, high-grade cells can reside in the bone marrow for many years undetected, treatment of some apparently localized high-grade prostate cancers can lead to a semblance of cure, especially when only followed for a few years.
Joe Busch MD, prostate MRI specialist, Chattanooga, Tennessee (personal communication) www.drcradiology.com/
PSA Testing IS Bad Health Advice
The PSA test and its 78 percent false positive rate; the DRE prostate exam and its coin-toss accuracy and, the risky 12-core, ultrasound-guided prostate needle biopsy sampling blindly and randomly ONLY some 0.1 – 0.3 percent of the prostate, are all highly unreliable. Clearly, the PSA test cannot be considered the gold standard and, PSA-based screening for prostate cancer is very bad health advice. A concern that has been echoed by the USPSTF (the United States Preventive Services Task Force).
Bert Vorstman BSc, MD, MS, FAAP, FRACS, FACS