Biopsy, Not PSA, Leads to Prostate Cancer

BY MARK SCHOLZ, MD

Prostate cancer is way over treated, and the problem starts with over diagnosis.  Once men are diagnosed, the fear of cancer naturally drives them toward radical treatment. In 2011 the US Preventive Services Task Force intervened, trying to stop overtreatment, argued that PSA testing causes more harm than good.

Some have questioned the expertise of the panel because of the lack of representation by urologists, radiation therapists or medical oncologists --the types of doctors usually responsible for treating prostate cancer.  Actually, the credentials of the panel constituents appear entirely appropriate to comment on screening, because this is an area of medicine usually handled by primary care doctors.  The panel members consisted of twelve MD’s and four PhD’s trained in primary care, public health and statistics.

The Task Force agrees that PSA screening may save lives. Their judgment, however, was that too few lives are saved to justify thousands of men getting unnecessary radical treatment. One statistic indicates that a thousand men must be screened to save one life within the next 12 years.

Personally, I agree with the panel in regards to over diagnosis is a root cause of over treatment. However, simply discarding PSA is an oversimplification. PSA can detect a variety of problems infection and benign prostate enlargement. Actually, the majority of men with elevated PSA, don’t have prostate cancer.

No, the real problem is after a PSA test rises. Every year, a million men are advised to have a dozen, large-bore needles jabbed into their rectums “Just to be sure there is no cancer.”  Such behavior sounds ridiculous, but really, it is just the survival instinct in action. People will do practically anything when they fear for their lives.

So if not a biopsy to evaluate an elevated PSA, what’s next?

First, the fear must be faced. Ralph Waldo Emerson says “Knowledge is the antidote to fear.” So let’s look at some basic facts:

• One out of 38 men die of prostate cancer
• One out of seven men are diagnosed with prostate cancer
• In men who are “diagnosed”
  • Five-year survival is 100%
  • Ten-year survival is 99%
  • Fifteen-year survival is 94%
    

Considering it is cancer, survival rates are great! At least these numbers should overcome any urge to rush. Clearly there is plenty of time is to study and learn more. Confusion arises because a minority of prostate cancers can indeed be dangerous. Not as dangerous as lung or pancreas cancer which kill within months. However, demise from prostate cancer certainly qualifies as “dangerous,” even if it is rather infrequent and much postponed.

These statistics reveal something else that is quite useful. Prostate management issues are of long-range nature, like saving for college or for retirement. Just as expert financial planners are limited in the ability to make predictions about economic activity ten years in the future, doctors should be equally humble in their pronouncements about the future of prostate cancer. We don’t know for sure, but we strongly suspect there will be substantial breakthroughs in the diagnosis and treatment of prostate cancer in the next ten years.

For the short term, I think the best way to proceed is with imaging the prostate with a 3Tmulti-parametric MRI or color Doppler ultrasound. Scans are about as accurate as a random biopsy for detecting aggressive cancers and they usually fail to detect the harmless low grade types, which is a good thing. However, if there is a worrisome abnormality, a targeted biopsy with just a couple cores is needed.

Over-diagnosis and over-treatment is not due to PSA. It’s the misguided policy of rushing into an immediate random biopsy whenever there is a slight elevation.  .The random biopsy procedure should be abandoned.  PSA abnormalities should be evaluated with prostate imaging A targeted biopsy can be considered in men who have a distinct abnormality detected by imaging.    

Confessions of a Treatment Conservative

BY RALPH BLUM

While studies demonstrate that the new gold standard for detection of clinically significant prostate cancer with a high degree of certainty is a combination of systematic and MRI targeted biopsies, the practicality of this approach still poses problems.

Mark has written many times about the growing pains involved in the common sense use of this sophisticated technology, and also its tremendous potential to finally help distinguish men with non-aggressive cancer who do not need treatment from those with aggressive disease who do.

Making this technology available to every man with prostate cancer who would benefit from it is problematic for one main reason—the process is not very available due to the relatively few centers of excellence that have access both to the technology, and to the highly skilled uro-radiologists capable of reading the MRI scans with accuracy.

Prostate cancer affects men in many different ways. Its management is complicated by extremely variable behavior patterns ranging from slow-growing and insignificant to rapidly growing and life-threatening. Sometimes an abnormal PSA suggests cancer but none is found at biopsy. Sometimes a man who is thought to be a good candidate for surgery will turn out to have cancer that cannot be effectively treated surgically. Other times a decision has to be made whether to treat what appears to be a very small amount of cancer and risk the inevitable side effects. All of these are issues where prostate MRI is of value.

The biggest challenge in prostate cancer treatment is to try to find all the cancer, but treat only that cancer which is aggressive. Multiparametric MRI scans can help identify areas in the prostate that are suspicious for aggressive cancer that can be missed by biopsy. They also happen to be safer, minimally invasive, and less uncomfortable!

The main reason that Mark and I wrote our book—Invasion of the Prostate Snatchers—was to try to prevent the exorbitant number of biopsies performed every year in the United States leading to immediate radical treatment that in many cases was totally unnecessary.

There is no doubt that advances in MRI technology could dramatically curb the number of biopsies performed and reduce unnecessary treatment of non-life-threatening cancers.  From my own experience of co-existing with prostate for over 20 years cancer, I remain conservative when it comes to invasive treatment.

PSA, The Human “Check Engine” Light

BY MARK SCHOLZ, MD


Why all the controversy about PSA? How can people fault a simple blood test that uncovers cancer at an early stage? The problem is that the PSA test doesn't specify what type of cancer the patient has. In addition to the presence of cancer, there are two other common causes of PSA elevation—prostate gland enlargement that comes with age, called BPH, and chronic prostate inflammation, called prostatitis.

PSA by itself doesn’t diagnose prostate cancer.  It is a nonspecific indicator, like the “check engine” light on the dashboard of your car.*  Does this eliminate the value of PSA?  Of course not.  An elevated PSA reading is a useful indicator of the need for further research into the cause.

The biggest fear--and the primary argument used by PSA naysayers--is that so many urologists recommend immediate random biopsy with any PSA elevation whatsoever.  A million men are biopsied annually in the US, resulting in the over-diagnosis of innocuous prostate cancers in about 100,000 men each year.  Most of these men end up undergoing unnecessary radical surgery or radiation.

So how do we eliminate the bathwater (random biopsies) without throwing out the baby (PSA)?  The first step is avoiding the trap of rushing headlong into something before learning the whole story. Since we know PSA is nonspecific, most elevations will be from prostate enlargement, not cancer.  PSA needs to be interpreted in relation to prostate size.

One might think that only ultrasound or MRI can reliably measure prostate size.  And while imaging is indeed the most accurate method, practiced doctors can roughly estimate prostate size with a simple digital prostate exam.  Also, there is a PSA blood test variant called “free” PSA that is suppressed in men with BPH.  Free PSA is reported out as a percentage of total PSA.  When free PSA percentage drops below 10%, BPH as a cause for PSA elevation is less likely.

Sequential PSA testing is the best way to diagnose inflammatory prostatitis, the other common reason for benign PSA elevation. Inflammation can increase PSA, which often oscillates up and down as the inflammation in the gland waxes and wanes.  This bouncing PSA pattern is in sharp contrast to an elevation of PSA caused by cancer.  A rise in PSA from cancer is usually unidirectional—up, up and up.

Historically, despite the drawbacks from biopsy of over-diagnosis, infections and discomfort, it has been the gold standard for diagnosing prostate cancer. Only very recently have new advances in multiparametric MRI imaging enabled men with PSA elevation to consider this imaging alternative--rather than random biopsy--as a first step. Our recommendation to use a multiparametric MRI (at a center of excellence) followed by a targeted biopsy if a suspicious lesion is detected, has been discussed in more detail in previous blogs. 

*I wish I could take credit for the check engine light idea that so nicely conveys the useful but nonspecific character of PSA.  This little pearl of knowledge was passed on to me by a patient. 

Raising Awareness about MRI Imaging of the Prostate

BY MARK SCHOLZ, MD

Prostate cancer screening presents a unique challenge.  Prostate cancer is a very common, but only a minority of cases are deadly.  This creates a serious problem.  It’s good to detect high-grade disease because early treatment reduces mortality.  But PSA screening detects a lot of men with low-grade disease and these men are harmed. Why? Well-intentioned but over-enthusiastic doctors recommend treatment even though it’s truly medically unnecessary. 

Why We Over Diagnose
So what can be done?  Physician propensity for overtreatment will only change slowly.  The shortest pathway out of this dilemma is to stop diagnosing so much low-grade disease.  The crux of the problem is the random needle biopsy, a “blind” procedure that is widely considered to be the necessary first step for evaluating elevated PSA.  A million men undergo biopsy annually; 250,000 men are diagnosed; around a 100,000 have low-grade disease the can be safely monitored with “active surveillance.”

The Next Evolutionary Step
Three-Tesla multiparametric MRI (MP-MRI) scans developed by Siemens, Philips and GE can reliably detect high-grade disease without over diagnosing low-grade disease; these scanners accurately differentiate high-grade from low-grade tumors.  The availability of these new scanners makes random biopsy as currently utilized by most urologists archaic. Random biopsy involves inserting 12 needles into the rectum.  Beyond its propensity for over-diagnosis, 3% of men are hospitalized with serious infections.  Also, it is relatively inaccurate, failing to detect high grade disease over 15% of the time.

New Technology Growing Pains
Most internists and urologists are still unaware of these important technological advances.  Even those who are aware are still learning how to translate these new imaging reports into practical recommendations for their patients. Also, there is the challenge of maintaining quality control in this rapidly expanding world.  Despite these barriers the advantages of using imaging as a first step can’t be ignored.  PCRI has posted a list of centers that perform this type of imaging.  While we have some familiarity with these centers, for liability reasons we are unable to offer any official certification of their quality and accuracy.  On the other hand, new as this technology is, we feel it would be a disservice not to spread the word about its availability.

CHECK OUT THIS VIDEO: SO YOUR PSA IS HIGH, NOW WHAT? http://youtu.be/6QgcfVBzFNs

Advances in Diagnosis: Magnetic Resonance Imaging

BY RALPH BLUM

Prostate tumors are often multifocal, which means they tend to occur in more than one place within the gland. The digital rectal exam performed by the urologist will often miss tumors. The PSA test, used to screen for prostate cancer, has a sensitivity of about 70% and will often yield unclear results. And the random prosate biopsy, which seeks to identify tumors, while performed systematically, is also done blindly, resulting in roughly one-third false negative results.



In recent years, Multi-parametric Magnetic Resonance Imaging (MP-MRI) has played an increasing role in prostate cancer detection. MP-MRI scans are now more effective in distinguishing cancer from normal prostate tissue.  And although MP-MRI is not yet considered the standard tool for diagnosis, it can uncover cancer that has been missed during biopsy. Moreover, MP-MRI plays a significant role in helping to determine whether active surveillance is a safe procedure, or whether a patient requires definite treatment.

Advances in MP-MRI technology include specific targeting known as MRI-guided biopsy. Since cancers that occur in the anterior or front part of the prostate are often not being sampled because they are “out of the reach” of standard biopsy techniques, they often contain undetected areas of cancer.  An optimal magnetic resonance imaging study employs a powerful magnet to create detailed images that are then displayed on a computer screen. According to K.J. Macura, MD, at Johns Hopkins:

Based on the scans, radiologists assign scores of 1 to 5 for the presence of prostate tumor on MRI, with 1 being deifinitely benign, 3 either benign or not (i.e. we can't tell), 4 being probably malignant, and 5 definitely malignant.

This greater specificity is valuable since a lower score indicates that a follow up biopsy may not be necessary, while high scores indicate that a confirmatory biopsy may be advisable, and that the disease may require up-grading.

There are various types of MRI equipment available. When my MRI was performed, the MRI unit was operating at “3T”, T standing for Tesla and 3 the current state of the art technology, a unit of magnetic strength that provides hundreds of images and a detailed anatomy of the prostate.  However as of 2014, most of the men I have spoken with have undergone MRI testing with the older, less comprehensive 1.5 Tesla unit.

And while the number  of the MRI centers that use the latest technology is increasing, progress has been slow. So if you are scheduled to undergo an MP-MRI-guided biopsy using transrectal ultrasound and MRI guidance, make sure your MRI guidance is performed with the 3-Tesla machine. The results may make the difference between your being subjected to unnecessary, invasive treatment versus continued on active surveillance.

 
If necessary, make a fuss. It's your prostate cancer and your life.

FIND OUT MORE ABOUT RALPH'S STORY IN THE BOOK Invasion of the Prostate Snatchers


 

Imaging is Superior to Random Biopsy

BY MARK SCHOLZ, MD

Recently, our attention has been directed at the overtreatment of low-grade prostate cancer.  While PSA screening has been fingered as the problem, overuse of random needle biopsies is the real culprit. Over a million men undergo biopsies every year to address concerns about the possibility of underlying cancer.  Few people realize, however, that random biopsy reveals low-grade prostate cancer in one out of five men in the general population—even if PSA is normal.

 

Most of these “cancers” are harmless. Even so, it’s hardly surprising that patients with “cancer” want immediate treatment.  The words “low grade” or “microscopic” can’t offset the instinctual fears generated by this venomous word.   Despite dire warnings about the risks of treatment-induced impotence and incontinence—and reassurance from experts that low-grade prostate cancer can be safely monitored—studies show that 85% of men still throw caution to the wind and get treatment anyway.

 

Imaging is “Blind” to Small Low-Grade Cancers

While latent prostate cancers are more common, aggressive prostate cancer is also a reality. After all, 30,000 men die every year of prostate cancer. Back when doctors believed that all types of prostate cancer were universally dangerous, prostate imaging, which often misses small, low-grade lesions, was deemed inadequate. However, now with a more modern perspective we know that color Doppler ultrasound or multiparametric, three-tesla MRI overlook low grade disease while still detecting high-grade disease accurately.  Imaging spares men the shock of an unnecessary cancer diagnosis and unwarranted treatment.

 

Targeted Rather than Random Biopsies

When an overtly suspicious lesion is detected by imaging, a targeted biopsy (a limited number of cores aimed directly at the lesion) is typically recommended. Lesions that are biopsy-negative or show low-grade cancer can be monitored without treatment.  If high-grade disease is diagnosed, further staging followed by counseling about treatment is needed.

 

The doctor who reads the scan summarizes his 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

When to Biopsy Ambiguous Lesions
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, bulge the prostate capsule or are associated with increased blood flow or diffusion. An ambiguous lesion may require biopsy if a subsequent scans show an enlarging lesion. Expert judgment that takes individual patient characteristics into account comes into play during a discussion between the patient and doctor about whether or not a targeted biopsy is indicated.

“Cross Checking” Ambiguous Lesions
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.

New Technology Brings Growing Pains
You might think that new technological advances would immediately revolutionize prostate cancer management. Not necessarily. Many doctors simply don’t know what’s now available. Those that are aware are often unacquainted with the full capabilities modern imaging can achieve. And finally, even the well informed doctors may be reluctant to venture outside their comfort zone to embrace imaging as a substitute for doing a random biopsy.

Final Thoughts
Lack of awareness about how random biopsy leads to the over diagnosis of harmless, low grade cancers is resulting in a 100,000 men undergoing unnecessary surgery and radiation every year. Forgoing PSA screening altogether is both foolish and dangerous. State-of-the-art prostate imaging, not random biopsy, should be the first step in evaluating men with elevated PSA levels.

Join us in Long Beach, CA at Barnes & Noble Marina June 26, 2014 @ 7pm- Ask the Author: Mark Scholz, MD will be discussing his book, Invasion of the Prostate Snatchers and Men's Health. More June events and details here: https://groups.google.com/forum/#!topic/prostateoncology/H1AE5oeW2jc 

A Prostate Biopsy Can be Dangerous

BY MARK SCHOLZ, MD

Last August, I railed against too many biopsies. However, my experience at a recent prostate cancer meeting prompted me to revisit the topic for today’s blog.  There is now general agreement among experts that prostate cancer is over-diagnosed.  I believe this results from the excessive use of random prostate biopsy and, all too often, leads to radical over-treatment.

More than a million men in the United States have prostate tissue extracted by transrectal needle biopsy every year. Of all those biopsied, one-fourth, about 240,000 men, are diagnosed with prostate cancer. Of these 240,000, between one-third and one-half—that is, from 80,000 to 120,000—are diagnosed with a harmless condition destined to remain dormant for life. And yet, despite the innocuous nature of low-grade prostate cancer, the great majority of these unfortunate men still undergo radical treatment with decidedly negative impact on their quality of life.

The unwillingness of surgeons and radiation therapists to withhold treatment for low-grade prostate cancer is not entirely surprising given that doctors are specifically trained to treat cancer.  Understandably, patient enthusiasm for treatment is also a major contributing factor, considering how dangerous it would be to withhold treatment of most any other type of cancer.

The overtreatment of prostate cancer is giving experts sufficient concern that editorials are appearing in prestigious scientific journals, such at the Journal of Clinical Oncology and Lancet Oncology, discussing the possibility of renaming low-grade prostate cancer something besides “cancer.” Everyone seems to agree that it’s unreasonable to name a condition cancer when we know this low-grade form doesn’t usually metastasize.

Given these daunting issues, I was interested to survey a group of twenty male experts at a prostate cancer meeting last month about their attitudes toward biopsy.  Because the average age of the group was around sixty, everyone in the group readily agreed that if all of us underwent a standard random biopsy at least five would be diagnosed with prostate cancer. With such a high statistical risk of finding cancer, I then asked by a show of hands if anyone was interested in having a biopsy.

While an unnecessary cancer diagnosis is one risk of biopsy, there is one other significant risk: the possibility of toxic effects of biopsy itself.  The Journal of Urology this month reports that with prostate biopsy the rate of infections serious enough to require hospitalization has quadrupled to approximately one in fifty. One out every twenty of these infected men admitted to the hospital actually dies—making the risk of death from biopsy is one in a thousand.

Not a single doctor raised his hand.

Fortunately there is an excellent alternative to random biopsy.  Modern prostate imaging with 3-Tesla MRI or color Doppler ultrasound, is just as accurate for detecting high-grade disease. When an abnormality is detected through imaging, it can be targeted with just one or two biopsy cores instead of randomly shooting a dozen cores throughout the gland. And yet, despite the obvious advantages of imaging and targeted biopsy, practically all biopsies done in the United States are being performed randomly. 

Sadly, the general public—including most primary care physicians and even perhaps the majority of urologists and radiation oncologists—remains uninformed about the advantages of modern imaging technology. For more information about biopsy and Imaging Technology see my March 27, 2012 blog, Biopsy, Biopsy Everywhere: http://prostatesnatchers.blogspot.com/2012/03/biopsy-biopsy-everywhere.html