Why Is There So Much Resistance to Active Surveillance?

BY RALPH BLUM

Multiple studies have shown that the survival rate of men with early stage low-risk prostate cancer who choose Active Surveillance, matches that of men who choose immediate surgery, and without all of the attendant risks. Men who choose Active Surveillance are enthusiastic about having dodged the double bullets of erectile dysfunction and loss of urinary control. So if the virtues of active surveillance are so obvious, and major medical centers like Johns Hopkins are reporting excellent results with their active surveillance program, why are prostates still being removed at a record pace?

One reason is the pressure on for-profit private hospitals to boost the volume of procedures in a bid to hold onto huge annual profit margins. And the 2,900 non-profit hospitals across the country, which are exempt from income taxes, actually end up averaging higher profit margins than the 1,000 for-profit hospitals—in one case more than $500 million in the fiscal year 2010.

I’m not suggesting that these jaw-dropping profit margins are solely the result of the drastic over-treatment of men with prostate cancer. However, there is also no doubt that prostate cancer is a multi-billion dollar industry.

Take surgical robots: The so-called Da Vinci Robotic system, broadly acclaimed as “state of the art” for prostate surgery, costs more than $1 million to acquire and install. Roughly $1,500 worth of parts must be replaced after every procedure. The Da Vinci System is now in use in more than 1,000 hospitals and clinics across the country. When a hospital invests that much money in a surgical robot and trains surgeons to use it, the pressure is huge to sell surgery over other treatments.

So the advent of robot-assisted prostatectomies has significantly increased the number of surgeries performed each year. Nationally, 80% of men over age 70 with low-risk disease are either undergoing radiation or having their prostates removed unnecessarily. Yet there is a confluence of new evidence that men with a PSA of less than 10 who had surgery gained no benefit from the procedure; that in many cases, no treatment is the best treatment.

Of course what Ted Turner calls “serious cash money” is not the only reason for the radical over-treatment of prostate cancer.  Even though 91% of men with this disease will have a normal life expectancy, a diagnosis of prostate cancer leaves most men reeling and, in many cases, with an overwhelming desire to “just cut it out”—despite the risks and life disrupting side effects one can expect if the delicate nerve-sparing surgery doesn’t go as planned. Yet according to prostate experts at Johns Hopkins, if urologists separated out men with low-risk disease and entered them in an Active Surveillance program, prostatectomies would dramatically decline and patients would be better off.

Research is currently underway at Johns Hopkins to further refine the protocols for separating out low-risk, slow-growing prostate cancers from the high-risk, aggressive cancers. And it is worth noting that, in the meantime, of the hundreds of men who have been enrolled in Hopkins’ Active Surveillance program, not a single patient has died of prostate cancer.

The Science Behind Active Surveillance

BY MARK SCHOLZ, MD

Active Surveillance versus the “Gold Standard”         
Ten years ago surgery was called the “Gold Standard,” the treatment to which every other kind of treatment should be compared.  Now you rarely encounter the Gold Standard argument to bolster surgery as the preferred treatment approach.  What scientific studies led to this change in perspective and why has it taken so long for this change to come about?
 
Finally, a Clear Answer
The final nail in the “Gold Standard” argument occurred in 2012, when the New England Journal of Medicine published a study by Dr. Timothy Wilt comparing the long-term outcome of surgery versus observation.¹ Between 1994 and 2002, seven hundred and thirty-one men volunteered to undergo either surgery or observation based on a coin flip. 

No Benefit for “Good” Cancer, Modest Benefits for “Bad” Cancer

The average age for the whole group of men was 67. The median PSA was 7.8. The study ultimately concluded that here was no difference in prostate cancer mortality with either approach. Mortality was within the expected range of statistical variation (5.8% died in the surgery group and 8.4% died in the observation group).  A small survival benefit for surgery was seen in men with a PSA over 10.  (Mortality was 12.8% in the observation group and 5.5% in the surgery group.) Dr. Wilt also reported the side effects of surgery.
     
Even before Dr. Wilt’s report was published, Active Surveillance had been gaining mainstream acceptance in the medical community. Multiple, independently-published studies consistently reach the same conclusion that Active Surveillance is safe.  Some of these studies are briefly summarized in the next few paragraphs. The full abstracts are posted on our website at www.keepmyprostate.com. 

Do All Men Have Prostate Cancer?

One of the most compelling arguments for forgoing radical treatment is based on the fact that prostate cancer is simply too common in the general population to represent an imminent threat to life. Studies of prostate glands removed from men dying of unrelated causes show that by the time they die, most men harbor prostate cancer.¹ That prostate cancer is incredibly common in the normal male population is also supported in another report from the New England Journal of Medicine where 4,692 healthy men over age 50 with a normal PSA (average 2.7) volunteered to undergo a simple six-core prostate biopsy.  The resulting biopsies showed that one-fourth of the men had cancer.²

Many Studies, Same Conclusion

Additional research has looked into comparing Active Surveillance with surgery. For example, a study from Johns Hopkins reported that life expectancy is only extended an average of 1.8 months by having immediate surgery.³  Another study in the Journal of Urology confirms that the grade of the tumor is an excellent method for determining which type of cancer is safe to monitor because prostate cancer mortality was almost nonexistent in 12,000 men with Gleason score of six or less  who were monitored for 12 years after surgery.⁴

Additional studies reporting the long-term outcome of Active Surveillance have been published: In a ten-year study of 1,000 men undergoing observation at Johns Hopkins Hospital, not a single man has died of prostate cancer or developed metastases.⁵ In another study of 450 men undergoing observation in Toronto that included some men with grade 7 disease, five out of 450 men died of prostate cancer.⁶

The Dark Side of Treatment

The idea of living with cancer may not seem at all attractive, but once the side effects of surgery are factored in, Active Surveillance starts to look really good. Unfortunately, the side effects of radical treatments like surgery are universally underemphasized by doctors and patients alike. Doctors downplay the effects of surgery because their years of working in the field accustom them to impotence and incontinence in their patients. The patients who have had treatment and are lucky enough to have had a good outcome, sing the praises of treatment because they took a radical step to remove their cancer and were fortunate to avoid bad consequences. The patients with bad outcomes are frequently too embarrassed to talk about their diapers and sexual incapacity.  They minimize the bad effects of the treatment and emphasize their gratefulness about “having been saved from cancer.”

The fact is that surgery and radiation cause permanent side effects with astounding frequency.  In a study of 475 men, four years after having surgery or radiation, less than 20% of men described their sexual function as returning to normal.⁷ In another study of 785 men, three years after surgery or seed implantation, less than 20% of men who had surgery and less than 50% of the men who had seeds described their sexual function as returning to normal.⁸ Unfortunately, to many people, all these statistics are an abstraction. Nevertheless, the tragedy of unnecessarily destroying even one man’s sexual identity cannot be calculated.

At First, New Thinking Always Seems Radical  

Let me close with an acknowledgement that Active Surveillance involves a totally new way of thinking. The very first conference to review the science of Active Surveillance was convened in San Francisco in 2007. At that time two hundred prostate cancer experts laid down the basic guidelines for Active Surveillance.  Doctors around the world are still being introduced to the idea of Active Surveillance. Believe it or not, some doctors have not even heard about it.  Inevitably, it takes time for people to change. Even so, that’s no reason for you to be trapped by outdated thinking.