African-Americans and Prostate Cancer

BY RALPH BLUM

The hard fact is that the death rate from undiagnosed prostate cancer for African-Americans is currently more than twice that for Caucasian men. Although scientists do not yet fully understand why this is so, it is widely believed that genetic differences, lifestyle, reluctance to undergo digital-rectal testing, and nutritional habits all play a role in these statistics. Which is why all African-Americans are urged to begin tests at an earlier age (40) regardless of their health history.

While African-American men are already at an increased risk for prostate cancer, that risk goes up even further if there is a family history of the disease. African-American men, with an immediate family member who had prostate cancer before age 65, have a one-in-three chance of developing the disease. With two family members involved, that risk rises to over 80%. This is why prostate cancer screening at a younger age is vital because by the time that symptoms appear, the cancer is more likely to be at an advanced stage.

The differences in prostate cancer diagnosis and treatment seem to account for a significant portion of the gap in death rates between blacks and whites.  First, black men are less likely than whites to have adequate insurance. Uninsured men have lower rates of screening and are less likely to see a health care professional. These men are more likely to be diagnosed with advanced disease –cancer that has spread outside of the prostate gland. It is worth noting that studies of blacks and whites in the military, where men have equal access to health care services, have shown that this equal access eliminates of most of the death rate gap.

So what can African-American men and their health care professionals do right now?  The advice is the same for black men as for all other men. Focus on early diagnosis through PSA screening.  The controversies about PSA screening are mostly related to over diagnosis of low-grade disease.  Many of these low-grade cancers don’t even need to be treated. They can be safely watched. And that fear can largely be address by evaluating an abnormal PSA finding with a MRI scan rather than a 12-core random biopsy.  Given the extremely high rates of prostate cancer in African-American men, getting a PSA test represents a simple but potentially life-saving act.

The Billion Dollar Question: Aggressive or Not?

BY RALPH BLUM

The billion-dollar question facing the approximately 240,000 men in the U.S. diagnosed each year with prostate cancer is: Do I get treated? Or not?

Overtreatment of prostate cancer is both a major problem and extremely costly both financially and physically.

Financially, because of the high cost of radical treatments and physically because most treatments can cause unpleasant and long-lasting side effects. Overtreatment was also the most important driver of the 2012 decision by the United States Preventive Services Task Force to recommend against routine screening for prostate cancer. Approximately 30-40% of men who have previously undergone surgery or other radical invasive treatment likely had indolent, slow-growing tumors that would never have become a threat to the man’s lifespan or health.  However, there is hope.

At the AACR-PCF conference in January 2014, Dr. Matthew Cooperberg, a urologic oncologist at the University of California, San Francisco (UCSF) warned, “If we don’t fix the problem of prostate cancer overtreatment, we will lose screening.” And losing screening would almost certainly mean more prostate cancer deaths—reversing a nearly 45% decline in mortality rates since screening started.

The crux of the problem is the supposed uncertainty about the accuracy of current predictors of tumor aggressiveness, leading physicians and patients alike to opt for a better-safe-than sorry approach that in turn results in extensive overtreatment. However, the vast majority of prostate cancers do not change their stripes. Cancers that appear to be slow growing when diagnosed are unlikely to cause serious problems during a man's lifetime. On the other hand, cancers that appear high-risk at diagnosis are indeed more likely to behave aggressively. So identifying them remains vital in deciding whether to treat or not to treat.

Some physicians and researchers are currently combining this clinical information with genetic information. Adding biomarker tests to clinical predictors further improves the identification of which prostate cancer patients could undergo Active Surveillance versus immediate treatment.

Now that Active Surveillance is a valid and safe way to treat low-risk prostate cancer men should not shy away from PSA screening.  We can’t return to the era prior to PSA screening.  Back then half the men diagnosed had cancer that was already outside the prostate.

The Unending PSA Controversy

BY MARK SCHOLZ, MD

The controversy about PSA has been reignited by new data from Lancet and recently reported in the NY Times.  Even though PSA screening reduces mortality from the aggressive type of prostate cancer, the Lancet article again confirms that far too many men routinely receive unnecessary radical treatment for a low grade type of prostate cancer that is essentially harmless, an entity that should never have been called cancer in the first place.

Grade 6 “cancers” are harmless. However, it’s hardly surprising that men (and doctors) push for immediate treatment anyway.  No amount of reasoning seems to ease the instinctual fears generated by this venomous word.  Despite warnings about impotence and incontinence—and reassurance that low-grade prostate cancer can be safely monitored— 85% of these low-risk men undergo radical treatment anyway.

Unfortunately, outrage against the genuine harms of overtreatment is routinely directed at PSA when the real culprit is the 12-core random prostate biopsy. I have previously weighed in on this matter in various blogs and videos, but the prostate cancer intelligentsia continues to be totally clueless, routinely blaming PSA rather than the ridiculous policy of randomly jabbing needles into the rectums of a million men annually.

Random biopsy could perhaps be justified if prostate scans were unreliable. In fact prostate imaging does often miss small, low-grade cancers; the very ones we now know are harmless. But for high-grade disease, color Doppler ultrasound and multiparametric, three-tesla MRI, are very accurate. Evaluating an abnormal PSA with an imaging study rather than a biopsy greatly reduces the chance of diagnosing grade 6 disease, the type that so commonly leads to unwarranted treatment.

Low grade cancers are incredibly common. However, higher-grade cancers also occur.  When imaging detects a high grade lesion, a targeted biopsy (a limited number of cores aimed directly at the lesion) should be performed. Lesions that are biopsy-negative or show low-grade cancer, can be monitored without treatment.  If high-grade cancer is confirmed, further staging followed by treatment counseling is needed.

Trained doctors using state-of-the-art technology read the scans and summarize their overall impression which falls into one of three categories:

1.        No evidence for high grade disease, no need for biopsy

2.        A suspicious lesion is detected, a targeted biopsy is necessary

3.        An ambiguous area is detected. Either a targeted biopsy can be considered or alternatively, ongoing monitoring with another scan in 6-12 months can be considered

Imaging “sees” all sorts of things besides cancer, including scar tissue, areas of active prostatitis, and nodular areas from BPH. Lesions of greater concern are located in the peripheral zone, over a centimeter in size, show bulging of the prostate capsule or are associated with increased blood flow or diffusion. An ambiguous lesion should be targeted for biopsy if it enlarges over time during observation on subsequent scanning. Expert judgment that takes each individual’s characteristics into account comes into play during a discussion between the patient and doctor about whether or not a targeted biopsy is indicated.

Color Doppler ultrasound and multiparametric MRI are complementary. In our experience, the imaging findings between these two modalities match 80% of the time. However, in a minority of cases, one imaging modality illuminates a specific lesion more clearly. Therefore, with ambiguous lesions using one modality, we usually consider additional imaging with the other modality before recommending targeted biopsy.

One would think that new advances in imaging would lead to an immediate revolution in prostate cancer management. Unfortunately many doctors are either unaware of what’s available or unacquainted with the full capabilities of the latest technology.  Finally, even well informed doctors may be reluctant to embrace imaging when they are well paid to do random biopsies.

Random biopsy continues to fly unscathed under the radar while people mistakenly blame PSA for the great misfortune of having thousands of men undergo unnecessary surgery or radiation every year. Forgoing PSA screening altogether is both foolish and dangerous. State-of-the-art prostate imaging, rather than random biopsy, should be the first step in evaluating men with elevated PSA levels.

Homage to Tom Stamey, MD

BY RALPH BLUM

Looking back on my two-plus decades of coexisting with prostate cancer, I see my travels as an odyssey; or perhaps hegira comes closer to the mark, since it has indeed been “a flight to escape danger.” Either way, along the route, at meetings, consults, conferences, I have listened to the opinions and prejudices of eminent healers, men and women I would—all matters of disease aside—be pleased to count as friends.

Among them are a number of urologists and oncologists, all of whom had at least two things in common. First, at some point in their careers they had been either students or colleagues of Thomas Stamey, MD, a leading expert on prostate cancer and godfather and midwife to the PSA blood test. And second, a recognition of the modesty and humility with which Stamey regards his own achievement.

The literature of prostate cancer is hardly known for quotable remarks. Like a few lines you come away with after seeing a good play. But then the only “theatrical” aspect of prostate cancer is the OR. And while a compelling case can be made for too many urologists (aka surgeons) appearing far too frequently in those theaters, I have only one memorable quote.

It is something Dr. Stamey said, his terse prophecy that is pinned to the shelf above the desk where I work, and that has appeared on more than one occasion in my writing. It is this: “When the final chapter of this disease is written, it will prove that never in the history of oncology will so many men have been so over-treated for one disease.”

According to Stamey, prostate cancer is a disease all men get if we live long enough, so given an excuse to carry out a biopsy, doctors will likely find cancer.  “Our job now,” said Stamey, “is to stop removing every man’s prostate who has prostate cancer. We originally thought we were doing the right thing, but we are now figuring out how we went wrong. Some men need prostate treatment but certainly not all of them."

Stamey also reminds us that almost all men over 50 years of age start to develop benign prostatic hyperplasia, and that PSA is related today to the harmless enlargement of the prostate and not to cancer. Although the PSA test is still useful in monitoring patients after surgery, as an indicator of residual cancer, it is not a reliable predictor of the amount or severity of prostate cancer.  Stamey recommends a yearly digital rectal exam for all men over 50, and his group at Stanford is currently working on finding a blood marker that could indicate the more aggressive forms of cancer.

The most significant question is how to combat the fear factor. Many urologists will likely continue to perform biopsies based on PSA results, find early stage cancer, and recommend immediate—and as it turns out,  in most cases, unnecessary— treatment. So in what Stamey calls “this heavily screened country” it is up to each of us not to let fear dictate our decision making, not to yield to the emotional appeal of “cutting it out.”  If we decided to choose a Patron Saint of prostate cancer, you know who my candidate would be.

Consider that prior to the advent of PSA testing back in 1987, 1 of 41 men in the United States died of prostate cancer.  In 2009, with almost universal PSA screening and early treatment, the risk of dying from prostate cancer has improved, but not as much as you might think.  Presently the risk is 1 out of 53.

The cost of this progress is substantial: Prior to PSA testing 90,000 men were diagnosed with prostate cancer annually.  Now 200,000 men are told they have prostate cancer every year.  And, an additional 800,000 men undergo a prostate biopsy without being diagnosed with the disease.

So if your PSA is elevated, before you commit to irreversible and unpredictable bodily invasion, take a minute to consider the odds, and mull over Tom Stamey’s prophecy: “When the final chapter of this disease is written . . .”

Over-Diagnosis and Over-Treatment in the Flourishing Prostate Cancer Business

BY RALPH BLUM

There are several reasons why over-treatment of prostate cancer is rampant in this country. The first is over-diagnosis. In 2011, despite the controversy about annual PSA testing, more than 240,000 men were diagnosed with prostate cancer. Many of these men were in their 70s and 80s; most of them with disease that would never be clinically significant in their lifetimes. But a diagnosis of prostate cancer put them at immediate risk for unnecessary treatment. Why? Because both doctors and patients over-react to the information PSA testing provides.

The responsible urologist is faced with a dilemma: the risk of over-treatment versus the risk of his patient dying from prostate cancer. As of this writing there is still no absolute certainty, when a man is first diagnosed, about how to accurately differentiate between clinically significant and clinically insignificant prostate cancer.

Then there is the financial aspect: prostate cancer treatment and management has become a flourishing industry. Studies have found that three-quarters of men with indolent, slow-growing tumors receive unnecessary aggressive treatment, when active surveillance would be far more appropriate.

According to researcher Janet Stanford at the Fred Hutchinson Cancer Research Center, between $2 and $3 billion is spent annually in the U.S. on initial therapy alone. Urology groups that have brought IMRT into their practices have utilization rates well above national norms for treatment of prostate cancer, and these practices also treat a higher than average number of men over the age of 80 with IMRT for their low-risk cancer. Furthermore, with the soaring popularity of the da Vinci robot and the enormous costs of acquiring one, not to mention being trained in robotic surgery, there is a very strong incentive for urologists to recommend its use.

I’m not suggesting that men are not willing partner’s in this rush to treatment. Most men, confronted with a choice of monitoring their prostate cancer—as opposed to “cutting it out” or zapping it with radiation—will unequivocally choose the latter, even knowing that it is likely to lead to reduced quality of life. One of the results? Over 70,000 unnecessary prostate surgeries annually—and rising.

While PSA screening isn’t a perfect method of detection, catching prostate cancer early has saved many men’s lives. Over the last 30 years there has been a 30% decline in the death rate from prostate cancer due, in part, to better screening. However, all you guys out there who are diagnosed in your 70s or 80s, be aware that the highest incidence of over-treatment is in your age group—as high as 60-65% and possibly higher.  So take your time, and carefully examine your options!

As the prostate cancer wars rage on, all newly diagnosed men are faced with prostate cancer’s version of the Hamlet dilemma (“To be or not to be…”). As Leonard L. Gunderson, M.D, M.S, FASTRO and ASTRO Chairman put it, “The problem with prostate cancer is not finding the cancer but in knowing when to treat and when not to treat.”

The First Decision: Screening for Prostate Cancer with PSA

BY MARK SCHOLZ

Prostate cancer is highly curable when it is identified at an early stage. The PSA blood test, although not foolproof, improves the chance of arresting cancer while it’s still contained within the prostate. Detecting prostate cancer early gives men the power to choose a variety of treatment alternatives.

Surprisingly there are arguments against PSA testing.  Since some types of prostate cancer are low-grade, and therefore slow growing, diagnosing them, especially in older men, may only cause unnecessary fear and anxiety. Even more disturbing, men with this low-grade, non-aggressive type may be encouraged to undergo unnecessary treatment that in many cases leads to urinary incontinence or impotence.

PSA elevations also can occur from non-cancerous conditions. Prostate infections, prostate enlargement and even recent sexual activity may cause the PSA to rise temporarily.  If none of these reasons can account for an abnormally elevated PSA level, an assortment of scans, blood and urine tests may be required to ferret out what is actually causing the elevation.

So we have a dilemma. Many men are given a PSA blood test without first being educated about its limitations. Advance discussions about the implications of an abnormal PSA, and prostate cancer diagnosis almost never occur. This is no small issue. Even though low-grade prostate cancer is incredibly common, many doctors are still unaware that recent studies show that low-grade prostate cancer can safely be monitored. Instead, when the diagnosis is made, most men are carted off to have radical surgery.

Despite all these daunting issues, I still believe that PSA screening is appropriate so long as men are informed about its limitations, and so long as the doctors who administer the test are well versed in the latest studies. In my next blog I will be addressing an even bigger question—whether to have a prostate biopsy when an elevated PSA occurs.

A New, Improved Ultrasensitive PSA Test: ProsVue

BY MARK SCHOLZ, MD

The PSA blood test has been much maligned of late. Experts are concerned that blind screening of the general population leads to more harm than good. The apprehension is that many men are getting swept up into unnecessary radical treatment to treat innocuous forms of prostate cancer.

The problem with PSA testing used for screening is that elevated levels in the blood can result from a variety of causes including recent sex, strenuous exercise, an enlarged prostate gland or prostate cancer.

However, PSA testing is extremely useful for monitoring disease progression in men with known prostate cancer. Management of the disease is greatly simplified by this blood test. Rising PSA levels in the blood indicate that the cancer is growing.  When levels are declining it serves as a clear signal that the cancer is responding to treatment.

PSA testing is particularly useful because it can be accurately measured in extremely small quantities, down to less than a billionth of a gram.  Thus, cancer can be detected and tracked long before metastases become visible on a scan.

Just recently the FDA approved an enhanced PSA test called ProsVue. The test, manufactured by IRIS Molecular Diagnostics, can measure PSA levels below a trillionth of a gram. This new test has proven useful as a diagnostic marker for detecting the presence of residual prostate cancer after surgery.

Such a test has a practical application in men after surgery to help determine who is likely to develop a cancer relapse, i.e. to determine which men have residual microscopic cancer left behind after the operation.  Only the individuals with microscopic disease are destined to relapse and will benefit by being treated with immediate radiation. Without the ProsVue, doctors have been giving radiation to everyone with positive surgical margins even though statistics show that only about half of the men being treated actually harbor residual microscopic cancer. 

Bottom line:  Previously published studies of standard ultrasensitive PSA assays used after surgery have shown some utility for predicting future cancer relapse. Therefore it is likely that ProsVue, which is substantially more accurate than existing PSA technology, will ultimately prove to be a useful and accurate test for predicting which men are at risk for a cancer relapse and are most likely to benefit from radiation.

Calling All 40 Year Old Black Men

BY RALPH BLUM

According to the National Cancer Institute, African Americans may have the highest rates of prostate cancer in the world. Furthermore, black men often develop the disease at a younger age than white men, and the cancer is often more aggressive.

Although the National Institute of Health is conducting studies to determine why this is the case, the reason for this disparity between African American and Caucasian men is complex and not yet clear. In part, it may reflect unequal access to quality health care because they tend to be diagnosed at more advanced stages, i.e., they wait till it’s too late.

While all African American men are at significantly higher risk, black men with an immediate family member who had prostate cancer have a one in three chance of developing the disease. The risk rises to 83% when two immediate family members have the disease, and with three family members, the risk mounts to 97%.

So it is absolutely vital to get yourself checked out before symptoms appear that indicate the presence of prostate cancer. Symptoms include: the need to urinate frequently (especially at night); difficult, painful, burning or bloody urination; painful ejaculation; frequent pain or stiffness in the lower back, hips, or upper thighs. Once symptoms appear, it means that the cancer has already reached a more advanced stage and chances of survival are considerably reduced.

In June 2003, Nation of Islam leader, the Honorable Minister Louis Farrakhan, announced the launch of his Prostate Cancer Foundation  (LFPCF). Minister Farrakhan, himself a survivor of prostate cancer, apparently saw the high death rate among African American men diagnosed with the disease as a call to action to the black community, and the strongest persuasion for early screening. “If that is not motivation to save your life,” he said, “then nothing can motivate you.”

Despite the lack of conclusive study results, one thing is certain: early annual screening for prostate cancer is critical for African American men and should begin at age forty to forty-five.

Aside from financial concerns, another factor that deters many African American men from getting regular screening for prostate cancer, is that it involves not only the PSA blood test but also the primitive yet effective doctor-inserting-finger-up-your-anus technique known as the Digital Rectal Exam (DRE) to which black men have a serious aversion. Minister Farrakhan put it rather more delicately: “As men, we are difficult in terms of allowing ourselves to be tested.” And that is a problem.

A word of caution: When I alerted two concerned black friends that “free annual pre-screening, educational materials and medical referrals were available” via the Louis Farrakhan Prostate Cancer Foundation in Chicago, they called the number provided on the LFPCF website, and got a Toyota dealership in Houston. It appears that the website has not been updated since 2003.

When I checked with a black minister who is concerned about prostate cancer in his community, he said, “The Rev. Farrakhan sometimes fails to follow through. Usually, it’s a question of funds. The African American community would welcome hearing words of encouragement from black authority figures like Oprah, Tavis Smiley and Rev. Jesse Jackson.”

Meanwhile, it is left to local groups to motive men to get tested. According to Ron Brewington, Associate Professor of Broadcasting Journalism at Santa Monica College, the Trinity Baptist Church on

Jefferson Boulevard

in Los Angeles does provide screenings. Addressing a group of men at the church recently, Brewington said, “I’d rather have a finger up my butt than have them throw dirt in my face. The fact that you’re here tells me you want to live. I applaud each of you.”

Deaths from prostate cancer in the United States have declined, primarily because more than 90 percent of prostate cancers are diagnosed at an early stage However, African American men are still more than twice as likely as white men to die of the disease largely because they continue to be diagnosed at more advanced stages. So if you are a 40 year old African American man, consider this a three-alarm wake-up call. 

Screening for Prostate Cancer Can Be Risky Business

BY MARK SCHOLZ

PSA Screening is Defensible and Essential

The majority of radical treatment decisions are made on the basis and results of PSA testing. PSA or Prostate-Specific Antigen, is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in the blood. Due to the dangers of overtreatment some experts have proposed forgoing PSA  testing altogether. However, this attitude is like throwing the baby out with the bathwater, since early diagnosis and treatment of high-grade prostate cancer unquestionably improves survival and quality of life.  

Too Many Biopsies and Too Much Treatment

In a perfect world the diagnostic process would detect all high-grade disease early and ignore all low-grade disease. Is such a goal attainable? The way things stand, it is unlikely. The present system relies on an immediate prostate biopsy when the PSA passes a specific threshold. Unfortunately, when cancer is diagnosed, regardless of the grade or risk level, immediate surgery or radiation usually follows.  

Primary Care MD’s to the Rescue

Primary care physicians can alter this landscape in two ways: First, by taking a more measured and insightful approach to selecting men for biopsy (see below). Second, by not delegating the treatment selection process to urologists after a biopsy shows cancer.  Urologists and radiation therapists do not always provide unbiased advice. An overview of how to select treatment has been published in a brochure available at the PCRI, entitled, Treatment for Newly-Diagnosed Prostate Cancer.

Estimating Risk of High-Grade Disease Starts with Prostate Size

PSA is only “normal” in relation to prostate size.  Prostate volume in cubic centimeters is measured with ultrasound or with MRI. A normal PSA  reading is one-tenth of the prostate volume.  Abnormal PSA is when the reading is 50% above normal.  For example, an abnormal PSA for a 30cc prostate is 4.5, for a 50cc prostate, it is 7.5 and for a 100cc prostate, 15 is considered abnormal. 

The PSA Test Is Not Perfect

Infections, lab errors and recent sexual activity can all cause an elevated PSA, If there is an infection, a course of antibiotics will bring the PSA down. However a false reading can be ruled out  with repeat testing.   Recently, a new urine test called PCA-3 became commercially available. Studies show that the amount of PCA-3 in the urine increases in proportion to both the size of the tumor and the aggressiveness of the cancer. Unlike PSA, PCA-3 is unaffected by the size of the prostate. 

Imaging

Prostate imaging with endorectal MRI or color Doppler ultrasound is improving rapidly. These imaging techniques are useful for measuring prostate size and for detecting high-grade prostate cancer. While imaging is not 100% reliable, studies indicate that larger amounts of high-grade cancer can be detected fairly consistently.  In situations where the need to do a biopsy is debatable, a high quality ultrasound or MRI study may provide additional assurance that a biopsy can be safely delayed. 

Look Carefully Before You Leap

Rather than rushing into a biopsy at the first sign of an elevated PSA, screening should be seen as diagnostic process combined with an ongoing dialogue with the patient. As information is gathered by repeat PSA testing, PCA-3 levels and prostate imaging, the likelihood of a biopsy diagnosing either low-grade or high-grade prostate cancer can be presented to the patient and compared with the risks of a biopsy.  

There are many mistaken fears about prostate cancer. These unwarranted concerns need to be addressed before diagnosis, before the word cancer becomes personal, and a man’s  capacity for rational thought is impaired.  

Most elderly men have prostate cancer and don’t know it.  And most are better off not knowing. Diagnosing low-grade prostate cancer can be a curse. Frightened patients are ill-prepared to navigate a powerful medical system predisposed to over-treatment. How bad is it? One New England Journal of Medicine study estimates that our system is so skewed that 48 men receive unnecessary treatment for each individual who truly benefits.