PSA Screening and Biopsy: Are They Really Necessary?
Phranq D. Tamburri, NMD
No topic in the current landscape of urology has been so discussed and wrangled as the topic of early screening for prostate cancer. With this spiraling medical debate, general practitioners and their patients, whom they must advise, are thoroughly and understandably confused. This article will attempt to succinctly present the cacophony of factors (medical, legal, patient perception, and even political) that are involved in prostate cancer screening and subsequent biopsy. The confusion over the past 5 years has remarkably led several scientific and medical organizations—such as the American College of Physicians, American Society of Internal Medicine, National Cancer Institute, Centers for Disease Control and Prevention, American Association of Family Physicians, and American College of Preventive Medicine—to recommend that providers not routinely offer prostate cancer screening to their patients. This is a radical shift in policy that traditionally supported screening at all costs. Richard J. Albin, PhD, the discoverer of the prostate-specific antigen (PSA) test, has publicly refuted his test: “The test’s popularity has led to a hugely expensive public health disaster.”1 Prostate cancer screening seems to be a simple test to perform, but it is not a simple decision to make.
Before the PSA test was commonly available (in the late 1980s), the incidence of and mortality from prostate cancer had been very similar for as long as such statistics were tracked. This is because prostate cancer is insidious; there are no early symptoms until it begins to ravage the body. Consequently, a patient was typically diagnosed as having prostate cancer only after later symptoms occurred (lower spine and hip pain, gross hematuria, anemia, and severe fatigue), at which point he would most likely succumb to the disease. Therefore, although some patients with late-stage prostate cancer died of some other complication or disease, most patients died of the prostate cancer itself.
In 1971, the US war on cancer had escalated with the introduction of the National Cancer Act under President Richard Nixon, which funded research for earlier detection for many cancers and in particular prostate cancer. This led to the formation of our current screening paradigm.
Foundational early screening includes the digital rectal examination (DRE) and the PSA test. Because the DRE palpates only the last one-third to one-half of the posterior caudal gland, it is unreliable as a first-tier screening tool. Furthermore, it is a procedure that patients may be unwilling to undergo and that some physicians are reluctant to perform. In addition, many prostate cancers found on biopsy are nonpalpable by DRE. This leaves its partner, the PSA test, to screen for hidden prostate cancer in the rest of the nonpalpable gland.
Prostate-specific antigen is an antibody that is secreted by prostate cells and is used to liquefy the seminal fluid. The PSA level tends to be elevated in blood when something affects the prostate. Although prostate cancer is thought of as the primary culprit, anything that affects the gland (infection, inflammation, sex, bike riding, etc) can elevate the PSA level. Therefore, as an early prostate cancer detection test, PSA screening yields many false-positive results. In fact, most men with an elevated PSA level do not have cancer; only 25% to 35% of men who have a biopsy performed because of an elevated PSA level have prostate cancer.2
An elevated PSA level likely leads to a biopsy for several reasons, including physicians’ fear of litigation for not detecting prostate cancer early and insurance companies’ willingness to pay for these procedures for similar reasons. Fear of lawsuits has led to increased use of a test that yields many false-positive results, which in turn leads to obtaining a biopsy specimen, and which if positive likely results in the prostate being allopathically treated and removed.
Yet, prostate cancer is statistically likely to have a benign course, as further discussed herein. The quandary for the diagnosing physician, who is constantly under scrutiny by litigation fears and malpractice attorneys, is how to advise the patient. If the physician tells the patient he has cancer but that he will probably statistically outlive it, what is the physician’s defense if he is wrong? The safest and legally protective option to follow is allopathic prostate cancer treatment (surgery, radiation therapy, etc). To do otherwise demands a level of education and consent from the patient that the typical physician’s office cannot accommodate because of time constraints and insurance reimbursement schemes.
Statistics from the American Cancer Society3 in 2010 reveal that 17 of 100 men will be diagnosed as having prostate cancer during their lifetime under current screening procedures, but only 3 of the 17 will someday die of it. Data from the Centers for Disease Control and Prevention4 in 2007 indicate that 233 307 men were diagnosed as having prostate cancer on biopsy performed because of an elevated PSA level, while only 29 093 died of it. In addition to the many false-positive results of the PSA test mentioned earlier, there is an inability to differentiate the fatal variant of prostate cancer from the more common benign form.
The reliability of the PSA test to detect cancer that will be found on biopsy is equally disquieting. Among men whose PSA level is 4.0 ng/mL or higher, biopsy will detect prostate cancer in 30 of 100 men.3 More surprising is that when the PSA level is below 4.0 ng/mL, prostate cancer is diagnosed in 15 of 100 men. This suggests that most men—regardless of that their PSA level is or whether they undergo biopsy that diagnoses prostate cancer—remain at the overall steady risk of prostate cancer mortality seen before the 1980s (before introduction of the PSA test). It has been concluded that PSA screening has no overall benefit for prostate cancer detection and mortality reduction. Such findings over the past 5 years were so shocking that in March 2010 the US House Committee on Oversight and Government Reform held televised congressional hearings on “Prostate Cancer: New Questions About Screening and Treatment.” (http://www.archive.org/details/gov.house.ogr.20100304.1).
A solution to the unreliable screening system is supported by many of the cancer organizations aforelisted, who advocate an enhanced and more comprehensive screen. Physicians are to expand basic screening (PSA test and DRE) to include a larger prostate cancer assessment process that uses many other prostate cancer laboratory tests, possible prostate imaging (transrectal ultrasonography of the prostate [TRUSP] and magnetic resonance imaging), and a detailed analysis of PSA values and history known as PSA kinetics. This advanced prostate cancer risk assessment strategy (detailed by me in prior issues of NDNR) is slowly becoming accepted by allopathic physicians.5 What does this mean for the typical patient and physician who are faced with limited office visit time or financial options that cover only the basic PSA test and DRE and follow-up biopsy?
While advocates of prostate cancer screening claim that it saves lives, growing numbers of NDs and others are questioning the value of the PSA test. Who is correct? They both are. The issue is rooted in patients’ views of their own personal healthcare and their financial resources. Further elements of the debate include bureaucracy, the specter of litigation, and patient quality of life.
Does PSA Screening Really Save Lives?
The short answer is yes. Since the introduction of PSA screening (with or without DRE), mortality from prostate cancer in America has decreased. Although the decrease has been minimal and in some instances statistically insignificant, a reduction nonetheless exists.6,7 From a purely utilitarian point of view, the PSA test has been successful in saving lives. The question not asked here is how many men were diagnosed as having prostate cancer on biopsy, refused to be treated, and outlived it. In addition, how many surgical procedures are performed to save a single life? According to data from the American Cancer Society,3 only 3 of 17 men diagnosed as having prostate cancer die of the disease; therefore, it takes 14 unnecessary prostate cancer procedures to save 3 men from dying of it. These are odds that many men are considering before rushing to have surgery.
Does Biopsy Truly Spread Cancer?
Although this question is tangential to the scope of this article, it should be addressed. Although prostate biopsy is overwhelmingly recommended to any patient with a suspect PSA test result, concern about prostate cancer tracking (also called seeding) is often cited as a primary reason why men refuse biopsy. To date, no peer-reviewed research has demonstrated that biopsy procedures metastasize prostate cancer around the body, which in itself is difficult to prove.
Circumstantially, I argue that biopsy does not carry a great risk of metastasizing prostate cancer throughout the body. The rationale is the numerous evidence demonstrating that PSA screening has reduced prostate cancer mortality. Given the explosive number of prostate biopsies performed in the United States since the introduction of the PSA test, one would expect an increase in prostate cancer metastasis and mortality. Instead, prostate cancer mortality has decreased since PSA screening was popularized in the 1990s. This does not preclude that a biopsy procedure may track prostate cancer within the prostate itself, resulting in 2 nodes of prostate cancer, where perhaps there was only 1 node. I conclude that the tracking concern is warranted but is only conjecture at this time.
Where Is the Debate if Prostate Cancer Screening Saves Lives and Biopsy Does Not Spread Cancer?
The issue spirals onward when one considers how many false-positive PSA test results occur and what any positive PSA test results mean to the healthcare system. Screening advocates do not see a problem with simply testing the PSA level and, if elevated, having a biopsy to determine if prostate cancer exists. They recognize the shortcomings of the test’s false-positive results, but they typically share a utilitarian belief that if it saves only one life it is worth it.
What seems to be a benign and caring PSA screen embarked on to save men’s lives, however, may put into motion a sequence of events that leads to performance of a surgical procedure with lasting adverse effects, such as erectile dysfunction or incontinence, that statistically was not warranted. Like a rancher’s livestock being herded down a cattle chute, the uninformed male patient may find that decisions were made on his behalf by the medical system that he would reasonably have disagreed with if he had had the proper understanding. What started out as a responsible health visit to the PSA screening van at his church led to a biopsy and subsequent surgical removal of a cancer that was statistically likely to have never affected him throughout his lifetime.
Consider also the patient who because of his profession (eg, an airline pilot) has to undergo mandatory routine laboratory studies, including PSA level. If he refuses, he could be suspended or fired. Yet, having the test performed may put into motion a sequence like that just stated.
These scenarios are important to understand. Most PSA screening advocates do not consider the repercussions of the decision tree. Because the typical medical practice and a patient’s insurance plan support only minimal time to assess the possibility of a fatal prostate cancer, the physician often falls back on medical standards like drugs and surgery.
In contrast, PSA screening opponents question the use of a test that is more often than not going to yield an unreliable result. If in fact the test results are reliably positive, that would lead to biopsy and surgery that would still be refused because the cancer is statistically not fatal.
To be clear, the American Cancer Society and many of the groups mentioned herein are not opposed to PSA screening. However, they recommend that the patient should understand both sides of this issue and make an educated empowered decision. Once a patient has a PSA test result, the wheels of the medical system and his own anxieties may begin to dominate.
The physician should have a good rapport with the patient to obtain proper consent and to communicate the risks and lack of guarantees. Only then is deferral of prostate cancer biopsy or surgery a legitimate and respectable option. Active surveillance guidelines are a proper strategy to follow before a prostate cancer is diagnosed.
In obtaining consent, I consider the patient’s mental state in refusing a PSA test, biopsy, or surgery. I typically ask him: “If I had a magic wand and could prove 100% that you have prostate cancer, then what would be your response?” If the patient states that he would be very concerned and would likely want to have the cancer removed, I advise him to follow through with a PSA test, biopsy, and potential surgery. Quality of life should always have relevance in one’s treatment options. A patient who is anxious about every PSA test, fixates on having cancer, or is upset daily about ongoing costs and treatments during hard economic times is not mentally healthy enough (in my clinical opinion) to pursue further screening. However, if the patient states that his decisions are predicated not on whether prostate cancer exists but on how qualitatively bad the cancer is, then this candidate is likely well suited for further assessment, biopsy, or surgical alternatives.
Although financial considerations are strictly best avoided when treating your patient, long-term resources are important in helping him decide his course. If he refuses biopsy following a suspect PSA test result or refuses surgery following a positive biopsy result, the physician taking on the liability risk must determine if the patient is able to pay for ongoing PSA screening and other assessment tools that will be required. This is critical for the ethical physician who is conducting an advanced prostate cancer assessment protocol. A patient should not be expected to deplete his nest egg if his condition worsens and he has to pay for expensive healthcare out of pocket (eg, for surgical services from the urologist).
Longevity of Life vs Quality of Life
I always ask the patient which of 2 qualities is more important: longevity of life or quality of life. Although results of a PSA test, biopsy, and other examinations like color Doppler may suggest an aggressive prostate cancer, the patient must determine whether living longer with potential adverse effects (such as erectile dysfunction and incontinence) trumps living shorter without these concerns. Although this question is listed last herein, it is typically one of the first questions I address during a patient’s visit. The stronger the patient leans toward quality of life, typically he is more positive, educated, and stubborn in fighting his disease and in making necessary radical dietary and health changes.
Understanding and Restraint Are Key
Prostate-specific antigen testing can be a valuable tool for assessing prostate cancer risk if it is used with understanding and with restraint. Unfortunately, prostate cancer screening today is often a trigger for the litigation-riddled medical system to initiate a biopsy and to pressure the patient to undergo a subsequent surgical procedure, both of which are possibly unnecessary based on statistical outcomes.
Phranq D. Tamburri, NMD, is founder and director of Prostate Second Opinions located in Phoenix, Arizona. The international service specializes in advanced prostate cancer risk assessment, which uses TRUSP color Doppler imaging of the prostate. He has served on many prostate cancer boards over the years, is a frequent radio guest, delivers annual urologic updates at medical conferences, and for the past 10 years has been a professor of urology at his alma mater, Southwest College of Naturopathic Medicine & Health Sciences, Tempe, Arizona. For leisure, he studies Austrian economic theory and listens to Tangerine Dream. Contact him at 4WeCare@gmail.com or 602-493-2273.
1. Ablin RJ. The great prostate mistake. New York Times. March 9, 2010. http://www.nytimes.com/2010/03/10/opinion/10Ablin.html.
2. Smith DS, Humphrey PA, Catalona WJ. The early detection of prostate carcinoma with prostate specific antigen: the Washington University experience. Cancer. 1997;80(9):1853-1856.
3. American Cancer Society. 2010.
4. US Cancer Statistics Working Group. United States Cancer Statistics: 1999-2007 Incidence and Mortality Web-Based Report. Atlanta, GA: Centers for Disease Control and Prevention, Dept of Health and Human Services, and National Cancer Institute; 2010.
5. Tambour PD. Advanced assessment of prostate cancer: a qualitative approach. NDNR. 2007.
6. Andriole GL, Grubb RL III, Buys SS, et al; PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009;360:1310-1319.
7. Howlader N, Noone AM, Krapcho M, et al, eds. SEER Cancer Statistics Review, 1975-2008. Bethesda, MD: National Cancer Institute. Based on November 2010 SEER data submission, posted to the SEER Web site 2011. http://seer.cancer.gov/csr/1975_2008/. Accessed September 22, 2011.