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 Radiation Round-Up

BY RALPH BLUM

Despite the significant advances in treatment options, there is still considerable uncertainty—even among doctors—about how or even whether to treat prostate cancer. The treatment controversy is the prostate cancer equivalent of a Dempsey-Firpo fight: the proponents of surgery slugging it out with those who favor some form of radiation.

In recent years we’ve seen the arrival of the elegant robotic surgery. Instead of cutting half-blind in a field of blood, with the da Vinci robot a surgeon can observe the anatomy blown up 100 times on a big TV screen and, with the aid of the robot, perform the complex and intricate surgery more precisely.

There are, however, two problems with this sophisticated new surgical procedure. First, it’s hard to justify the significant additional cost of the robot because the results are not that much different from those obtained with traditional surgery.

The second problem is rather disquieting. I have observed the power of the robot as a selling tool—a blend of high visibility, big bucks, slick advertising—with the result that a considerable number of men who really do not (repeat, do not) need surgery in the first place are seduced, Pied Pipered into the O.R. by what one critic called the “bloodless glamor” guaranteed by the da Vinci robot. You might want to consider my earlier blog, “The Robots Have Landed.” 

My feeling —depending, of course, on your risk category—is that if you are going to opt for radical treatment you should be lining up for one of the state-of-the-art targeted radiation treatments: either radioactive seed implantation, or intensity modulated radiation therapy (IMRT).

So how do you determine which you should choose?

Not all men are candidates for radioactive seed implants, otherwise known as brachytherapy. It is not recommended for men with enlarged prostate glands, men with pre-existing urinary problems, or men with cancer outside the prostate. If, however, you are eligible, seeds have the advantage of a single hospital visit, whereas IMRT requires daily sessions at a specialized facility for two months. Also, with seeds, the radiation dose is minimally higher, giving you the possibility of slightly better cure rates.

Bottom line your decision to go for seeds versus IMRT is mainly influenced by your risk category. In my case, if, after all these years of “prostate cancer coexistence,” if I decided on treatment, I would choose IMRT because it can be administered to a slightly broader field, thus creating a wider margin around the gland and even, if necessary, radiating the surrounding lymph nodes.

You will undoubtedly hear conflicting opinions about which treatment is best for you, and your decision will inevitably be complicated by multiple factors. With any prostate cancer treatment there is the risk of side effects, but with targeted radiation therapies the risk is significantly reduced. Moreover, both of these therapies—seeds and IMRT—are at least as effective as surgery at curing the disease without the additional risks of a major operation.

The Robots Have Landed

BY RALPH BLUM

Nearly every industry on God’s good earth has become mechanized in some form or another over the past 200 years, and the Prostate Cancer Industry—yes, it’s an industry, folks—is no exception. Enter the da Vinci Robot.

In 2009, according to Intuitive Surgical Systems (the company that manufactures the da Vinci robot), 85,000 American men, 86%  of those who underwent prostate cancer surgery that year, had robot-assisted surgery. Furthermore, roughly 75% of today’s urologists are being trained in robotic surgery, and the da Vinci robot is now found in more than 1000 hospitals and clinics across the country, snipping, slicing and dicing the family jewels. These are fairly staggering statistics. So let’s examine this infatuation with the robot.

Undoubtedly robotic surgery is currently the most advanced treatment option for men with localized cancers who still belong to the “just cut it out” school of prostate cancer. In the hands of an experienced robotic surgeon, you will experience less blood loss, less pain, a shorter hospital stay—usually only one or two nights—and faster recovery. Some men claim to be teeing off in a week. All great selling points. But what is the downside?

Obviously recovery varies from man to man depending on age, general health, and cancer stage. However it is not at all clear whether the long-term results or survival rate after robotic surgery are better, worse or the same when compared to the traditional open prostatectomy. And despite the marketing frenzy surrounding robotic surgery, studies to date show that rates of incontinence and impotence are virtually identical to the results obtained with the traditional methods, and ultimately depend on the skill and experience of the surgeon.

According to a recent study, a year after robotic surgery only one out of four men had recovered the ability to have intercourse. Another new survey showed that half of the men who undergo robotic surgery experience a greater incontinence problem and less sexual function than they anticipated.

A radical prostatectomy, whether traditional or robotically assisted, is a complex and intricate surgery. The prostate is located within millimeters of the bladder and the rectum, giving the surgeon very little room in which to work. And blood pooling in the operative field makes it seriously challenging to avoid damaging the nerves—thinner than a human hair—that run along each side of the prostate and control erections. Even in the hands of the most highly skilled surgeon you are fortunate if you achieve what Dr. Peter Scardino, Chief of Urology at Memorial Sloan-Kettering calls a “Trifecta:” negative margins (meaning no cancer left behind after the operation), maintained potency, and preserved urinary control. However, in less skilled hands such  good results are extremely unlikely.

Remember, it’s the surgeon behind the robot who is actually performing the operation. Even the best surgeons report impotence rates of up to 50% and incontinence rates of 10%. And not all surgeons are created equal. Too often, operations are being performed at community hospitals by surgeons without sufficient experience.

Opinions differ widely about how many robot-assisted operations a surgeon needs to perform in order to be considered “proficient.”  Some researchers estimate as few as 150 to 200 procedures. Others claim that as many as 1,600 operations are required in order to gauge with 90% accuracy how much tissue surrounding the prostate needs to be removed to get all the malignant cells.

Bottom line: A good outcome depends on the experience and skill level of your surgeon. So choose carefully. And before you decide, be sure to ask how many robot-assisted prostatectomies he has performed. You do not want to be part of your surgeon’s learning curve.

The lure of the robot is high-tech glamorous. The promise of a less invasive surgery with faster recovery time, plus the expectation of a better long-term outcome (based more on marketing hype than on actual studies), has almost doubled the number of radical prostatectomies performed each year in this country. So before you make what is sure to be a life-changing decision—and especially if your prostate cancer is the low-risk variety or you are 70 or over—don’t let all the publicity, or your urologist’s bias in favor of robotic technology, persuade you that surgery is your best treatment option.

Data from the recent Prostate Cancer Intervention Versus Observation Study (PIVOT) indicates that a vast majority of the 85,000 prostate cancer surgeries performed in 2009 were simply unnecessary. In other words, most of those men would live just as long without any surgery at all, and would be spared the risk of impotence and incontinence. Clearly men are failing to get the full picture of the risks and benefits of all the different options—Surgery, Seeds, IMRT, Testosterone Deprivation, Hormone Blockade, Focal Cryotherapy, Active Surveillance—before they commit to robotic surgery.

So, yes, the robots have landed. And whatever else is still uncertain, one thing is for sure—they employ first-rate Madison Avenue publicists.