Tuesday, December 22, 2020

Can we still Trust PSA Blood Test Readings?

This section originally published 8/26/20 @ The American Council on Science and Health (www.acsh.org)

Patient-Specific Anxiety: "My PSA was 22. I had a biopsy; it was benign...GOOD! The biopsy showed inflammation, so I had a (surgical) biopsy I didn’t need... BAD!  There has to be a better way!” 


Evolution of NON-INVASIVE PROSTATE DIAGNOSIS 
Prostate cancer, now considered the most common cancer in men, especially African-Americans (6-NIH), was rare until the 1950’s. Earlier, a blood test identifying prostate specific antigen (PSA was developed for use in “rape kits” to provide criminal evidence in court) was never designed as the screening tool for prostate cancer that it has become  today. Our national guidelines recommend screening with PSA for men age 55 to 69, a recommendation that 40% of men follow. But what happens after a PSA test is termed positive?
In 2012 the U.S. Preventive Services Task Force (USPSTF) recommended against routine PSA screening for prostate cancer due to the risk of over-diagnosis and over-treatment with most prostate cancer remaining asymptomatic. The panel concluded that the potential benefit of testing did not outweigh the risk of harm, arguing against continued screening except for those with known risk factors and a life expectancy greater than 10 years. Screening may have indeed reduced the rate of death from prostate cancer by an estimated 20%, but it was also associated with a high risk of overdiagnosis (diagnosis in men who would not have clinical symptoms in their lifetime).  This means that PSA testing would have saved about 60,000 lives but some 900,000 men would have undergone the undue injury of an unnecessary surgical biopsy. 

THE BIOPSY is an invasive procedure removing a small section of tissue and examination for cancer cells.  It remains the gold standard in diagnosing prostate cancer. Biopsies are now performed in an office setting, using topical or sedation anesthesia. It involves using a needle to obtain tissue from the prostate through the rectum. Twenty five years ago the routine biopsy protocol called for six needle cores. Because it was performed without imaging, it missed many cancers deep within the prostate. The number of tissue samples taken was expanded to 12 and even up to 96 cores at some centers. Needle biopsies cause serious complications in 1% of patients - even fatal outcomes have recorded. Infection which can require prolonged antibiotic therapy is the most common problem. Nowadays biopsies are guided, meaning that doctors use imaging through ultrasound or MRI  to direct the needles to areas of concern. 

CALLING FOR A DIAGNOSTIC UPGRADE
The strategy of relying on a (PSA) blood test as the precursor to a biopsy required significant reassessment.  Though approved by the FDA in 1986 as the gold standard for monitoring cancer relapses, increasing reports continue to indicate that elevated PSA levels in over 70% of men show a false positive reading- and does not conclude a malignant cancer. (NIH ref). Because of the inaccuracies of the PSA test and the risk of side effects, many centers are now using imaging solutions like ultrasound 3-D Doppler and MRI before considering a biopsy.


OVERDIAGNOSING: Why a one-off PSA test for prostate cancer is doing men more harm than good (source: Cancer Research UK)

Prostate cancer is the most common cancer in men, with 46,690 cases diagnosed each year in the UK. The PSA blood test is one of the main ways, along with a rectal exam, that doctors can look for signs of prostate cancer. The test measures the level of PSA in a blood sample. And while it’s normal for men to have some PSA in their blood, a raised level can be a sign of prostate cancer. But PSA can be raised for lots of other reasons too, meaning a man might get an abnormal result when he doesn’t have cancer.

It seems counter-intuitive to suggest that some cancers would be better off left alone. Especially when early diagnosis can boost treatment success for some cancers. But these overdiagnosed cancers pose a serious problem.  Some cancers grow fast and spread quickly, but some grow so slowly that if they went undetected they wouldn’t cause a person any problems. People with these harmless cancers won’t have any symptoms, and they won’t die from the disease. In other words, it doesn’t matter if the cancer is never found. When these slow-growing cancers are found they’re said to be over-diagnosed.  Read more: Overdiagnosis – when finding cancer can do more harm than good (see complete article @ CancerResearchUK)



"PSA is a Very Old Test", says a Frustrated Patient
By "Cousin" Sal Banchitta, Ret. FDNY

PSA Tests seem to remain as the gold standard in any institutional checkups- including fire departments all across the country.  After all, its the easiest and most affordable way to get a base line (barring its accuracy) and the insurance companies favor this.  

Four years ago, my annual retirement exam started with a blood test. My primary found my PSA was slightly elevated, so I was then sent to the urologist as standard operating procedure.  Before you know it, I received a report of a "slightly" enlarged prostate which put me into what felt like an automated track to getting a biopsy.  Getting a biopsy without an MRI or any type of imaging made the needle work a complete and painful shot in the dark. Getting poked 12+ times in what felt like complete guesswork was terrible experience. In the end, we found that the biopsy could have been avoided if the PSA reading gave more information, and a more accurate assessment. As a member of a family predisposed to cancer, the stress of waiting for the biopsy, then actually undergoing the procedure thinking I MAY have have cancer or not was completely an unfair ordeal to put anyone through.

Thanks to a little Google search, I took matters in my own hands and met a tumor imaging specialist who uses Doppler Ultrasound technology to scan the prostate (Dr. Robert Bard).  It was easy, affordable, accurate and provided real-time answers in minutes. The radiologist found the spot and identified a pre-cancerous tumor, but not one that demanded heavy concern- and certainly not a biopsy.  He later taught me about other diagnostic options like AI powered MRI's and the new liquid biopsies that are now available to (someday) replace the PSA test.  My faith still lies on medical imaging for cases like these...  where pictures tell the whole story and without all that undue stress and blind testing.

For more articles, see: www.CounsinSal.org

THE CANCER IMAGING ADVANTAGE

Medical imaging (and screening) especially of cancer tumors has advanced since the establishment of the x-ray in 1895.  Imaging earned the acceptance in the medical community as a low-risk, reliable and non-invasive (no-cutting) alternative.  It is widely employed today as a routine and standardized diagnostic protocol in almost every area of healthcare.  Treatment specialists and research scientists alike rely (solely) on medical imaging technology as the go-to protocol to investigate a patient's physiological condition in pathology studies. 

The DIGITAL MOVEMENT and the "end of FILM in radiology" was part of the global tech evolution- driven by the "Economics of Scale theory of Faster-Better-Cheaper". The digital imaging revolution harvested and processed images from an electronic photo conductor, managed bio-information into electronic pixels for more efficient management of diagnostic studies.  The Digital state allowed for computerized intervention to optimize and expand the data acquiring process to new heights of study including 3D modeling- offering a 3D visualization of anatomical studies.  This also paved the way for the induction of AI (artificial intelligence) which was developed to automate analytical paradigms (algorithms) for quicker analysis, advanced workflow, optimized visual dissection, extrapolation and 'prediction' of any biological information with remarkable performance.  

DOPPLER ULTRASOUND: In 1994 Prof. Francois Cornud in Paris developed a better way to sample the tissue of the prostate using Doppler ultrasound. Doppler shows tumor vascular flow the same way the Weather Doppler shows tornadoes as bright yellow colors so the more red tumor vessels in the sonogram means more aggressive pathology. The presence of tumor related blood vessels also poses a hazard during biopsy that might result in bleeding and infection even though it indicates a more serious tumor.   The accuracy of the Doppler analysis is so accurate that inflammatory arteries may be distinguished from malignant vessels meaning biopsy may be avoided in inflamed areas.  Not only is the Doppler map of tumor vessels useful as a cancer marker for determining metastatic potential it is often used as a treatment guide. Arteries that grow the malignancy are reduced in the presence of effective cancer treatment making this 10 minute examination both safer for diagnosis but also a means of indirectly monitoring therapy. 

Since, prostate cancer is in many instances, slow growing, early cases are often managed by watchful waiting, without invasive surgery, hormone therapy or chemotherapy. Ultrasound imaging that detects increases in tumor vascularity allows patients with biopsy proven cancers to come in for regular scans to see if their disease is stable if more aggressive treatment is indicated.

3D/4D ULTRASOUND: Computers have greatly enhanced medical imaging. Current Doppler systems capture 250 images in 10 seconds in three directions. These “multiplanar” images are reconstructed by the software allowing us to see the prostate capsule far more clearly than an MRI since the examining probe touches the prostate gland. This is important as extension of a cancer into the capsule or through the outer margin surrounding the prostate implies possible tumor spread to other organs.

These technologies have been further improved because the Doppler’s images are focused on specific areas using 4D to target a concerning site and additional data describing blood flow is obtained. This data can be combined to generate a quantitative reading of the tumor vessel density to serve as a treatment guide.  Vessel density of 15% is found in aggressive cancers requiring intervention; while densities of 1-2%  are noted in most low grade tumors that are monitored by 6 month ultrasound appointments.

Remember the biopsies that evolved from 6 to 96 cores? Ultrasound probes have progressed from 9 MHz used by urologists to 18 in radiologic systems to 29. The 29 MHz probe recently developed in Europe is currently used to avoid biopsies today in some US medical centers although its has limited depth penetration. These combined imaging systems are reducing  prostate biopsies in clinical practice.

MRI IMAGING: MRI has been the “gold standard” which as been greatly improved with the addition of contrast “dye” which has occasional serious allergic reactions. The presence of inflammation, both acute and chronic, makes MRI reading confusing since the vessels of infection  simulate  those feeding cancers.  Prostatitis with accompanying scar formation has resulted in false positives and unnecessary biopsies. MRI scans are often used to guide the biopsy needle placement.  Recent advances in the cumulative clinical data from ultrasound is so accurate that it is replacing MRI and follow up biopsies in many patients. 

NON CONTRAST / EZRA MRI: Just as ultrasound Doppler is used to avoid dye (contrast) injection, the heavy metal containing Gadolinium MRI contrast is being phased out by the upgrades in MRI technology. In use in Europe for 3 years, a version is now available in the US that affords high resolution without contrast injection. (more info)

ELASTOGRAPHY: Cancer is texturally hard – so a firm mass in the breast or a rock hard area in the prostate are strong clinical indicators of malignancy. The accuracy of an experienced digital rectal exam is generally 3 times more accurate than the PSA and its refined variations. Advanced  sonogram technology quantifies tissue hardness and is used worldwide to avoid biopsies in many organs-primarily breast, thyroid, prostate and liver.


IMAGE-GUIDED TREATMENTS
In addition to watchful waiting, many surgical options with robotic procedures are available. Radiation may use seed implantation or delivered by various external beam devices.  Radioactive treatments are useful when the prostate tumor has expanded outside the gland. Hormone and chemotherapies are common alternatives. It is advisable to seek medical opinions on personalized healing options as side effects occur and treatment is best individually tailored. Recurrence may occur following successful initial therapy of any treatment modality and Doppler ultrasound with MRI is useful in detecting any regrowth. 


About the Author

ROBERT L. BARD, MD, PC, DABR, FASLMS
Dr. Bard received the 2020 nationally acclaimed Ellis Island Award for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, Sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation.






First Responders Cancer: Inspiring a Global Diagnostic Upgrade

It has been confirmed by toxicologists and medical reports worldwide that OCCUPATIONAL HEALTH DISORDERS are predominant in the fire service. First responders hold potential cancer risks from the most extreme toxic exposures in every fire rescue call.  My diagnostic practice (in mid-town NYC) provided care for many first responders from 9/11 as well as current active duty firefighters. For those with low grade tumors, yearly monitoring with sonograms is a safe and easy solution- agreeing to be biopsied only when a significant change is noted in comparison.  Thanks to non-invasive diagnostics, men relying on alternative treatments would come in to check if their “natural products” were helping. Experience showed over 50,000 scans since 1974 identified low grade cancer (Gleason 3+3) turns aggressive in less than 1% over a 10 year time frame.  

The radiology community took time to appreciate that pathologic cancer tissue under microscope can be clinically dormant with some patients.  This means a biopsy that looks like malignancy can act like a chronic disease. New high resolution ultrasound units and computerized optical devices are now used instead of MRI for diagnosing Prostate Cancer in Europe and guiding biopsies without x-rays. MRI has shown to be less accurate in the upper and lower parts of the prostate gland and has a 33% false positive rate in the presence of inflammation. When the sonogram finds prostatitis, MRI is deferred until the infection is resolved. 

From our experience working with the many first responder cases, we have been alerted to the greatly increased risk of cancer following toxic exposure. Surprisingly, first responders are developing prostate and skin cancers at a higher rate than lung cancer. New portable sonogram systems are able to find and quantify the heavy metal effects on the skin in a 5 minute exam which is now called ULTRASOUND BIOMICROSCOPY. This is important since tissue under a microscope is not living while sonogram technology gives a live tissue real-time virtual biopsy.


RELATED ARTICLES

 What makes for added concern are the numerous WHITE DOTS (calcific foci) surrounding the dark area which are micro-calcifications, otherwise called testicular microlithiasis (TM) or micro-stones. According to a 2018 study, this uncommon condition of micro-stones is linked to testicular cancer (as well as male infertility) possibly increasing one's risk as much as 1200%. While not technically a precancerous condition, any man with these microcalculi should be checked periodically whereby small tumors could be treated focally if caught early. Since this 9mm tumor cannot be felt by itself, the simplest way to accurately identify the cause of the enlarged testis is with a high resolution sonogram. This non invasive screening may be also recommended for male family members. (See complete article)


REFERENCES

1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6186003/

2) End of an Era: The Demise of Film in Radiology: https://radiology.ucsf.edu/blog/imaging-news/end-of-an-era-the-demise-of-film-in-radiology

Bard R:  Contrast MRI and 3D Doppler Ultrasound   presented at the

109th Annual Meeting of the American Roentgen Ray Society   (2009) Boston 

Bard R:  Contrast MRI Atlas of Prostate Cancer    (2009) Springer Berlin

Bard R: Editor; Image Guided Prostate Cancer Treatment    (2013) Springer New York

6) African American Men More Likely to Die from Low-Grade Prostate Cancer: NIH



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