Posts Tagged ‘USPSTF’

PSA Absurdity

January 31, 2015

Andrew Siegel MD   1/31/15


(Image designed  by Abby Cycotte for WAPC)

Prostate cancer is the most commonly diagnosed cancer in males (excluding skin cancers)—paralleling breast cancer in females in many ways—with an estimated 233,000 new cases diagnosed in 2014. Over the latest 5-year period for which data is available, the death rate for prostate cancer decreased based upon improved early detection and treatment. There are 3 million prostate cancer survivors in the USA. The vast majority of prostate cancers are diagnosed by Prostate Specific Antigen (PSA) screening, a simple blood test.

Prostate cancer screening with PSA has been the subject of intense controversy and debate, a controversy that I—as a practicing urologist—don’t quite get. A major backlash against screening occurred in 2012. It started with the United States Preventive Services Task Force (USPSTF) grade “D” recommendation against PSA screening and their call for total abandonment of the test. Of note, there was not a single urologist on the committee. The same organization had previously advised that women in their 40’s should not undergo routine mammography, setting off another blaze of controversy. As a busy clinical urologist for almost three decades, I was deeply disturbed by their recommendation.

In 2013 the American Urological Association (AUA) issued guidelines recommending against PSA testing before age 55, with testing every other year between ages 55-69 and then only after “informed decision making,” a discussion between physician and patient weighing benefits and harms.

AUA Guideline Statements:

  1. Do not screen men under age 40.
  2. Do not screen men age 40-54, unless high risk (family history or African American), in which case decision should be individualized.
  3. Screen men 55-69 after informed decision making.
  4. Screening interval of “two years or more” may be preferred to annual screening to reduce harms of screening.
  5. Do not screen men older than 70 or any man with life expectancy less than 10-15 years, although some men in excellent health may benefit from screening.

When these guidelines came out, I was in disbelief and shock. Why did the AUA—whose mission statement is “to promote the highest standards of urological clinical care through education, research and in the formulation of health care policy”—kowtow on this vital issue?

Further fueling the controversy and confusion is the lack of consensus among professional groups including the European Association of Urology, the National Comprehensive Cancer Network and the Prostate Cancer World Congress. Uncertainty in the lay press has prompted both patients and physicians to question PSA testing and recommendations for prostate biopsy.

Is there really any harm in screening? Screening provides information and there are no side effects aside from whatever complications may ensue from drawing a small amount of blood. There are potential side effects from prostate biopsy (although they are few and far between) and certainly there are potential side effects with treatment; however, it seems that both the USPSTF and the AUA have confused screening with treatment. The potential side effects of active treatment should not influence the diagnosis of prostate cancer by the proper means. “Treatment or non-treatment decisions can be made once the cancer is found, but not knowing about it in the first place surely burns bridges.”—Dr. Jay Smith

I ardently disagree with the assertions of the task force and the AUA. Urologists, radiation oncologists, and medical oncologists (those physicians who are in the “trenches” and take care of prostate cancer on a daily basis) understand how devastating prostate cancer can be and the importance of early detection.

So what has been the upshot of this controversy? What has happened is that instead of proceeding directly to prostate biopsy, many more men with an elevated or accelerated PSA are having repeat PSA testing (often fractionated to determine free PSA/total PSA), the PCA-3 urine test and a prostate MRI. If the regulatory agencies had cost savings on their agenda, they have failed miserably as more testing (that incurs a significant expense) is being done than ever before.

Busy urologists are seeing more and more indecision and equivocation among primary care physicians who are confronted with patients who want screening, but guidelines that suggest that it is not necessary. Despite the USPSTF recommendations and AUA guidelines, urologists are actually seeing more referrals for elevated PSA than ever before.

Hard Facts:

  1. PSA screening has resulted in downward stage migration—detecting prostate cancer in an early and curable stage, before it spreads and becomes incurable. If these guidelines are adhered to, we will most certainly give back the gains we have made and experience a reverse stage migration and a return to the pre-PSA era when up to 20% of men presented with advanced disease.
  2. PSA testing unequivocally reduces metastatic prostate cancer (cancer that has spread) and death from prostate cancer: USA death rates from prostate cancer have fallen 4% annually since 1992, five years after introduction of PSA testing.
  3. Rigid guidelines unfortunately do not allow for a nuanced and individualized approach to early prostate cancer detection. PSA has many shortcomings, but used intelligently and appropriately will continue to save lives.
  4. Baseline PSA testing for men in their 40’s is useful for predicting the future of prostate cancer.
  5. Not permitting men age 40-55 the opportunity for screening denies them the potential to diagnosis a disease that is potentially lethal; this population has a long life expectancy and therefore the greatest need for early diagnosis and curative treatment.
  6. Older men in good health with over a 10-year life expectancy should not be denied PSA testing simply on the basis of their age.
  7. 95% of male urologists and 80% of primary care physicians have annual PSA screening—clearly, those in the know feel that screening is beneficial.
  8. Death from prostate cancer is unpleasant, often involving painful metastases to the spine and pelvis and not uncommonly, kidney and bladder outlet obstruction; our charge as urologists is to try to not let this scenario come to fruition.

When interpreted appropriately, the PSA test provides important information in the diagnosis, pre-treatment staging, risk assessment and monitoring of prostate cancer patients. Marginalizing this important test does a great disservice to those who may benefit from early prostate cancer detection.

I have practiced urology in both the pre-PSA era and the post-PSA era. In my early years of training, it was not uncommon be called to the emergency room to treat men who could not urinate, who on digital rectal exam were found to have rock-hard prostate glands and imaging studies that showed diffuse spread of prostate cancer to their bones—metastatic prostate cancer with a grim prognosis. In the post-PSA era, that scenario—fortunately—occurs on an extremely infrequent basis thanks to PSA screening. The vast majority of men who present that way these days are those who have opted NOT to obtain a screening PSA as part of their annual physical exams.

Bottom Line: The downside of screening is over-detecting low-risk prostate cancer that may never prove to be problematic, but may result in unnecessary treatment with adverse consequences. The downside of not screening is under-detecting aggressive prostate cancer, with adverse consequences from necessary treatment not being given. We need to separate screening from treatment and screen smarter.”—Dr. Judd Moul

The major challenge for those of us who treat prostate cancer is to distinguish between clinically significant and clinically insignificant disease and to decide the best means of eradicating clinically significant disease to maintain quantity and quality of life. Not all prostate cancers require active treatment and not all prostate cancers are life threatening. The decision to proceed to active treatment is one that men should discuss in detail with their urologists to determine whether active treatment is necessary, or whether surveillance may be an option, appropriate in selected men with low-risk prostate cancer (low PSA; minimum number of biopsies showing cancer; low-grade cancer as determined by the pathologist). Those at greater risk can be managed appropriately (surgery or radiation) and many cured, avoiding the potential for progression of cancer and painful metastases and death.

“PSA is the best screening test we have for prostate cancer, and until there is a replacement for PSA, it would be unconscionable to stop it. Contrary to the USPSTF report, compelling evidence shows that PSA screening reduces prostate cancer deaths. This evidence needs to be shared with the public.”
–Dr. William Catalona

The Samadi Challenge For Prostate Cancer

Dr. David Samadi, Chief of Prostate Robotic Surgery at Lenox Hill Hospital, has created a challenge to women, since they are the proactive gender in terms of understanding the importance of health risks, screening and routine checkups and are often the driving force in men’s health.  Men are much more reluctant to engage with the health care system than women—particularly preventive health care—and Dr. Samadi sees women playing a pivotal role in encouraging men to focus on prostate health. On a larger scale, he sees women as ideal advocates and champions to help raise global awareness for prostate cancer. The Samadi Challenge involves women learning the risk factors for prostate cancer, improving the lifestyles of the men in their lives, encouraging men to have annual screening and in the case of being diagnosed with prostate cancer, urging men to seek appropriate treatment. Dr. Samadi launched a FaceBook page: “Women for Prostate Health,” a means to help women initiate a conversation about prostate health.

Wishing you the best of health,

2014-04-23 20:16:29

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Screening For Prostate Cancer Revisited

December 14, 2013

Blog # 132

The ignoramuses at the United States Preventive Services Task Force (USPSTF) gave Prostate Specific Antigen (PSA) testing a grade “D” recommendation and called for the complete abandonment of the test for prostate cancer screening.

Having lived and worked deep within the trenches of urology for over 25 years, I almost stroked when I read their recommendation. I previously crafted video responses:

and gave a “horse’s ass” award to the USPSTF in another video:

The Prostate Cancer World Congress took place in Melbourne Australia in August of 2013, where experts proposed a consensus view on the early detection of prostate cancer.  This material was published in the British Journal of Urology International.

The consensus was engendered by the great confusion generated after the USPSTF called for the total abandonment of PSA testing. The international experts who wrote the consensus statement included 14 international experts on prostate cancer, unlike the USPSTF, where there was not a single urologist on the committee.

The experts at the Prostate Cancer World Congress adopted the following five statements:   

  1. For men age 50–69, evidence demonstrates that PSA testing reduces death from prostate cancer by 21% and the incidence of metastatic prostate cancer by 30%.
  2. Prostate cancer diagnosis must be uncoupled from prostate cancer intervention.  In other words, not everyone with prostate cancer will need to be actively treated and the potential side effects of active treatment should not influence the diagnosis of prostate cancer by the proper means.
  3. PSA testing should not be considered on its own, but rather as part of a multivariable approach to early prostate cancer detection.  The experts proposed the use of prostate examination, family history, ethnic background, prostate volume, as well as a variety of risk models based upon PSA.
  4. Baseline PSA testing for men in their 40s is useful for predicting the future of prostate cancer. Men with baseline values that are high need further PSA testing.
  5. Older men in good health with over a 10-year life expectancy should not be denied PSA testing on the basis of their age.   This population of older men may certainly benefit from the early diagnosis of aggressive prostate cancers. This does not pertain to men with numerous other significant medical problems, but a healthy man in his mid-70s should not be denied PSA testing that might identify a cancer that has the potential to destroy his quantity and quality of life.  (In particular, the older man who comes to the office accompanied by his father should certainly not be denied!)

The consensus was that we should maintain the gains that have been made over the years since PSA was introduced—in terms of decreasing the number of men diagnosed with prostate cancer metastases (cancer that has spread) and reducing prostate cancer deaths—while minimizing the potential harms of over-diagnosis and overtreatment by increasing the use of active surveillance protocols in those men with low-risk prostate cancer.   Abandoning PSA testing as recommended by the USPSTF would lead to a reversal of all gains made over the course of the past 30 years.  Well-informed men should be offered the opportunity for early diagnosis of prostate cancer. To quote Dr. Jay Smith:  “Treatment or non-treatment decisions can be made once the cancer is found, but not knowing about it in the first place surely burns bridges.”

My take on the subject of screening for prostate cancer:

I like to keep things simple…I believe in two rules that are appropriate for medicine as well as just about everything in life.

Rule # 1: Do no harm.

Rule # 2: Do good.

To apply these rules to the game of golf, for example, “do no harm” means staying out of trouble as much as possible, keeping the ball out of the woods, bunkers and water hazards.  “Do good” by hitting the ball accurately in terms of distance and direction and setting up the next shot.

Screening for prostate cancer involves taking a medical history, doing a rectal exam to check the contour and consistency of the prostate, and a simple PSA blood test. “Do no harm” is satisfied because these tests are in no way harmful to the patient and provide information that is helpful, particularly when done on a serial basis, noting changes over time.

If exam shows an irregularity of the prostate, if the PSA is elevated, or if the PSA has accelerated significantly over the course of one year in a reasonably healthy man who has at least a ten-year life expectancy, doing a prostate ultrasound and biopsy is indicated. This test does entail a small risk of bleeding and infection, but the potential benefits far outweigh the risks.  “Doing good” is satisfied by the knowledge provided by the biopsy—the reassurance that comes from a biopsy report that shows no cancer and the potential for cure if the biopsy shows cancer.  Furthermore, the specific biopsy results along with other factors can predict which cancers are low-risk, which are medium-risk, and which are high-risk, important considerations in terms of active treatment versus active surveillance.

Many men who are found to have low-risk prostate cancer (low PSA; minimum number of biopsies showing cancer; low-grade cancer as determined by the pathologist) can be followed without active treatment (active surveillance) and those at greater risk can be managed appropriately (surgery or radiation), and many cured, avoiding the potential for progression of cancer and painful metastases and death—all while weighing the benefits of intervention against the risks.  Death from prostate cancer is unpleasant to say the least, often involving painful metastases to the spine and pelvis and not uncommonly, kidney and bladder obstruction, and our charge as urologists is to try to not let this scenario ever come to fruition.

One of our fundamental goals as urologists is to screen for prostate cancer—

the most common cancer in men present in 17% of the population—and if present, to provide appropriate guidance to best maintain both quality and quantity of life.  Anyone who reads the obituaries knows that prostate cancer is a cancer that is lethal, and if you don’t read the obituaries, I can promise you that prostate cancer kills in unkind ways. Even though only 3% of the male population dies from prostate cancer, that amounts to many thousands of men annually… and you do not want to be one of them.  I have my own PSA and prostate exam done every year and PSA screening was responsible for making an early diagnosis of my father’s prostate cancer in 1997, which was cured by surgery, resulting in a healthy and thriving, cancer-free 82 year-old man who will never die from prostate cancer.

BOTTOM LINE: PSA remains an invaluable screening tool for the detection of prostate cancer and ALL men ages 50 and over (40 if there is a family history) should be tested…IT JUST MAY SAVE YOUR LIFE!

Andrew Siegel, M.D.

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