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.

Important News on Active Surveillance

BY MARK SCHOLZ, MD

For men with prostate cancer on active surveillance or (“watchful waiting,” as it is often known), new and compelling data from a large study called the “PIVOT  Trial” was presented at the annual meeting of the American Society of Urology this May. In this trial, which started in 1994, 731 men volunteered to get either watchful waiting or immediate surgery based on a coin flip. The goal of the trial was to determine if immediate surgery prolongs life compared to watchful waiting.

The men in the study had a median PSA of 7.8. One strength of the study was the fact that 75% of the men were diagnosed after biopsy for a rising PSA (as opposed to feeling a lump on the prostate).  This means that these study results can be more easily compared to the situation men face in this modern era. The weakness of previously published watchful waiting studies was that they were done on men with more advanced disease, cancer that was diagnosed by feeling an abnormality on the prostate gland during a digital rectal exam (DRE)—so called palpable disease, a situation that is far less common these days. 

The breakdown of the risk categories of the men participating in the study was similar to what is commonly reported in men with newly-diagnosed prostate cancer in the modern era:

·         43% Low-Risk

·         36% Intermediate–Risk

·         20% High-Risk

The surprising finding, after 12 years, was that there was no difference in survival between surgery and watchful waiting in the Low-Risk or in the Intermediate -Risk group.  On the other hand, men who were in the High-Risk category did benefit with improved 12-year survival when treated with immediate surgery compared to the men with High-Risk disease who did watchful waiting.

The results of the Pivot Trial are very important because up till now only men with Low-Risk prostate cancer were thought to be safe candidates to do watchful waiting.  

We eagerly await the final publication of all the data from the PIVOT trial since expanding the recommendation for watchful waiting to men with Intermediate-Risk disease would essentially double the number of men in the United States who would be eligible for monitoring. Additionally, this new discovery that men with Intermediate-Risk prostate can be safely monitored provides even stronger assurance to men with Low-Risk disease who have been experiencing trepidation about forgoing immediate treatment.