It is time. We need to rationally approach prostate cancer with new tools. Imaging first -- biopsy last.
In 2004 Dr. Thomas Stamey, Chief of Urology at Stanford, published a seminal journal article in the Journal of Urology, heralding the end of the PSA era. He had been known as "the father of the PSA." This was not greeted with great applause. He concluded that PSA testing was not an accurate measure of prostate cancer. In subsequent years, he has admitted the correlation coefficient between PSA testing and prostate cancer is approximately 20 percent. That is less than even odds that an elevated PSA equals prostate cancer. (Vigorous sex can raise your PSA up to 40 percent.)
Men are in constant fear of an elevated PSA and its implications. It's like watching the Dow. But the approach has been too slow to evolve.
Let me give you the best example. Women typically have an annual mammogram -- often followed by an ultrasound (it should be the opposite). If a suspicious mass is found, a wire-guided biopsy is performed. This is very targeted and limited only to the specific area of interest. A positive biopsy is now most commonly followed by a lumpectomy. The story then becomes complicated.
For men, the approach is backwards, and medieval. A suspicious digital rectal exam, followed by an elevated PSA (greater than 4.0) will inevitably demand a prostate biopsy. Fifteen years ago this would have been a "four core" sample. Four blind stabs. But over the interval there has been a tendency to increase to eight cores, then 12 cores and now 16 cores. Blind stabs through an area that cannot be sterilized. This can frequently cause infection, bleeding and pain.
It is time for this approach to come to an ignominious end.
We now have a far more sophisticated approach -- endo-rectal MRI scans with spectral analysis. The first and foremost was located at UC San Francisco. The most prominent center is now located in Thousand Oaks, Calif.
A PSA greater than 4.0, followed by a suspicious a digital rectal exam, can be referred for an endo-rectal MRI. No biopsy. The endo-rectal MRI has high specificity. Any suspicious lesion is accurately localized and graded with a "Gleason score." The key characteristic is "gland confined." This means that the tumor is intra-capsular. These are slow growing tumors. We need perspective.
If the MRI is positive, then an image-guided biopsy with no more than one to four cores is obtained under local anesthesia with considerably less pain and fewer complications. There is no reason why men are not routinely referred for these MRI scans, thus bypassing prostate biopsies.
Why is this not done? Routines. Medical algorithms. Reimbursement patterns. Surgeon training. Community "standard of care" nonsense.
There was a time 40 years ago when the time-honored Halsted radical mastectomy approach to breast cancer was finally questioned and a new era of lumpectomy was ushered in. This was only after a few brave individuals questioned the wisdom and necessity of "time-honored" radical procedures.
The time for a new approach for men has now come. But you must be persistent and seek a new course. You must be educated and demand from your physician/urologist that do not want (or need) a biopsy. You want the endo-rectal MRI with spectral analysis first.
This seismic shift could literally revolutionize the approach to prostate cancer and decrease the unneeded and unnecessary procedures and algorithms that follow. Did Warren Buffet need therapy?
We have seen the formulation of "task force recommendations" that are confusing the issue. Current recommendations, which make no sense, state all men greater than 65 should not be PSA tested and younger than 65 be PSA tested with caution.
Benefits [of PSA testing] seemed to be limited to men younger than 65 years. Treating approximately 3 men with prostatectomy or 7 men with radiation therapy instead of watchful waiting would each result in 1 additional case of erectile dysfunction. Treating approximately 5 men with prostatectomy would result in 1 additional case of urinary incontinence. Prostatectomy was associated with perioperative death (about 0.5%) and cardiovascular events (0.6% to 3%), and radiation therapy was associated with bowel dysfunction.
Conclusion: Prostate-specific antigen-based screening results in small or no reduction in prostate cancer-specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary.
But it is a misunderstanding of the specificity and variability of the PSA, which is not based on imaging studies. Serial PSA values are essential. It is the velocity curve that determines the possibility of prostate cancer. You don't stop testing. You learn how to more accurately profile the extent and aggressiveness of disease.
Send this blog to all your friends and loved ones. You can effect this paradigm shift. You deserve a 21st-century approach to this disease.
Philip Lee Miller, MD
May 9, 2012
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