Alternatives to Immediate Prostate Biopsy

BY MARK SCHOLZ, MD

Your PSA is elevated. Now your doctor recommends a needle biopsy, 12 cores through the rectum to check for cancer in the prostate.  Sounds icky, but also logical; after all who wants to miss cancer? But come on, do you really have to do 12 stabs via the rectum?

Each year over a million men submit their prostates for a biopsy.  At an average cost of around four thousand dollars, the prostate biopsy business is a 4-billion-dollar-a-year enterprise.  But it’s not merely the cost that gives pause.  Three percent of men end up hospitalized with life-threatening infections.  Around a 100,000 men every year get a confounding diagnosis of Grade 6 prostate cancer, a truly harmless entity, unless you get suckered into an unnecessary radical prostatectomy.

Obviously, prostate biopsy is an unpleasant proposition with notable risks.  However, ignoring a high PSA incurs the risk of missing a diagnosis of a higher grade prostate cancer. As things stand now, of the million biopsies being done annually, over a hundred thousand men with Grade 7 or higher cancers are being detected. For these men, their early diagnosis is beneficial, leading to early, curative treatment in a timely fashion.

How can we detect the 100,000 men with higher-grade cancers that need to be detected without doing 900,000 “unnecessary” biopsies?   The answer to this question continues to evolve as technology marches forward. Our latest thinking at Prostate Oncology (assuming the PSA is not wildly elevated, say over 20) is a three step process:

1.    Simply repeat the PSA to confirm it is indeed abnormally elevated.  All sorts of things can cause temporary elevations of PSA ranging from nonspecific inflammation of the prostate, to recent sexual activity, to simple laboratory errors. 

2.    If the PSA remains elevated with repeat testing the next step to consider is an OPKO-4Kscore blood test. The OPKO test reports a percentage estimate of the likelihood of higher grade cancer being present.  The test is not perfect, but it performs pretty well.  For example, if a specific patient receives an OPKO report with an estimated risk of high grade disease of less than 15%, a standard random biopsy (if he elected to do one) will confirm the absence of high grade disease 92% of the time. Not bad.

3.    Our next step at Prostate Oncology, in the cases where a patient has an OPKO test indicating that the risk of high grade disease is over 15%, is to obtain a prostate scan with high-resolution color Doppler ultrasound or with a 3-Tesla multiparametric MRI. With scanning, the location of the high-grade disease can be determined over 90% of the time so that a targeted biopsy with 2 or 3 cores can be substituted for the traditional 12-core biopsy.       

The business of prostate biopsy has become so out of control the US Preventative Services Task Force advocates against PSA testing altogether.  The Task Force’s scientifically-based arguments that PSA testing is causing more harm than good are really quite convincing.  However, back in 2011 when they published their recommendations, the OPKO test and 3-Tesla multiparametric prostate MRI were unavailable. With the advent of these new technologies, PSA screening to detect higher grade prostate cancers at an early stage when they are still curable makes perfect sense. 

The Premature Biopsy Blues

BY RALPH BLUM

As I have said many times I am no fan of biopsies, but to most urologists, an elevated PSA calls for an immediate biopsy. A majority of urology practices rush men into biopsy despite the risks and discomfort involved, and despite the fact that there are other, far less invasive indicators to help determine what is going on in the prostate before doing a biopsy. If these indicators point to the presence of an aggressive cancer, submitting to a biopsy to get further information is appropriate. But in most cases, it is not appropriate, and almost inevitably gets you a first class ticket on the Overtreatment Express.

Prostate cancer is different from other cancers and, in a majority of cases, far less malignant. Accumulating studies show that approximately 30% of men in their fifties, and as many as 70% of eighty-year-old men, harbor microscopic amounts of the disease. In fact, in the opinion of one well-known urologist, "If you are over seventy, and you don't have prostate cancer, chances are you're a woman."

Yet despite the fact that so many men have it, less than 3% of men in the U.S. die from it, and the mortality rate is dropping every year.

So if your PSA is elevated, take a deep breath and don't panic. Rather than triggering an immediate biopsy, an elevated PSA should set a risk assessment process in motion. More than half the biopsies in this country are done for evaluation of an elevated PSA coming from BPH—an enlarged prostate. And there are various other non-cancerous causes of an elevated PSA. So check them out and repeat the test. Still elevated? Insist on having an OPKO-4k blood test. Studies show that the OPKO-4K can not only demonstrate the presence or absence of cancer, it gives a readout on the likelihood of higher-grade cancer, the kind of cancer that should be treated rather than watched.

Some major cancer centers use 3-Tesla, multi-parametric MRI as a diagnostic tool. Also to be considered is another form of imaging—color Doppler ultrasound—that is comparable in quality to MP-MRI, is easier to perform, takes less time, can be done in the doctor's office. Color Doppler provides higher resolution images than the usual gray-scale ultrasound machines, and also shows areas of increased blood flow associated with higher-grade or more aggressive prostate cancers. If a suspicious lesion is detected a targeted rather than a random biopsy can be performed.

PSA is a remarkable tool. However PSA testing alone frequently gives an inconclusive message. So if your PSA is slightly elevated, instead of submitting immediately to a random needle biopsy that would likely lead to un-called-for radical treatment for a non-threatening cancer, ask your urologist to slow down. Now is the time to gather more information by testing with OPKO-4K and color Doppler ultrasound. Never forget that prostate cancer is the tortoise of cancers, so don’t be frightened into making a decision you might regret.  This is one situation where taking the Local may provide a better ride than the Express.    

First Stop on the Overtreatment Express: The Unnecessary Biopsy

RALPH BLUM

The first four words of the subtitle of our book, Invasion of the Prostate Snatchers are, “No More Unnecessary Biopsies.” At the appropriate time, a biopsy is an essential diagnostic tool. Unfortunately, however, far too many urologists still schedule an immediate biopsy if there is even a slight rise in PSA. And that has led to a multi-billion dollar industry bent on administering treatment to every kind of prostate cancer, whether it is life-threatening or not.

So what do you need to know before agreeing to submit to a biopsy? There are several possible reasons for an elevated PSA besides cancer:

1. A prostate infection, in which case a simple course of antibiotics may be all it takes to lower PSA into the normal range. Years ago my PSA went zooming up from an infection.

2. PSA rises after sexual activity, so abstinence is necessary a day or two prior to testing.

3. Recent bicycle riding activity can cause an elevated PSA.

4. An enlarged prostate—aka Benign Prostatic Hyperplasia, or BPH—usually results in an elevated PSA. More than half the biopsies in the U.S. are performed for evaluation of an elevated PSA coming from BPH.

5. A random laboratory error is always a possibility, and occurs more often than we realize.

So rather than triggering the scheduling of an immediate biopsy, an “abnormal” PSA should set a risk-assessment process in motion. The first step is to eliminate any of the above possible causes—checking for an infection, repeating the PSA to see if a lab error caused the elevation, performing an ultrasound scan to determine the size of the prostate to see how much BPH is present, and to determine whether the ratio between PSA and prostate size is in the expected range.

 

If these measures all fail to explain the elevated PSA, further testing—with an OPKO-4K blood test that is specific for high-grade cancer—should be considered before resorting to a biopsy. Other useful procedures prior to undertaking a biopsy are color Doppler ultrasound and/or multiparametric  MRI. Imaging studies provide an accurate measure of the prostate size so that the PSA “density” (PSA elevation in the context of prostate size) can be calculated.  If  the OPKO-4k,  PSA density and imaging are favorable, then surveillance with periodic PSA and  imaging, may be preferable to an immediate biopsy.

 

You have probably realized by now that I am not a fan of biopsies.They can be painful, can cause erectile dysfunction, and fail to spot cancer as much as 20% of the time, especially in men with large prostates. But the main reason I am against unnecessary biopsies is because of the unnecessary radical prostatectomies that usually follow—estimated at above 80,000 annually in the U.S. alone. Having a biopsy is like opening Pandora’s box.

 

According to Thomas Stamey, M.D., who developed the PSA blood test, prostate cancer is a disease that almost all men get if they live long enough. So the older the man, the more likely a biopsy will reveal cancer. But that doesn’t mean every man should have his prostate removed. However, only too often, that is what happens. The treatment of choice of most urologists is surgery (they are, after all, surgeons), and most men yield to the emotional appeal of “cutting it out.” This unfortunate situation is what led to Stamey’s famous quote: “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.”

 

An unwarranted biopsy is the first stop on the Overtreatment Express.