Robot, Robot, Burning Bright …

RALPH BLUM

If you have read some of my previous blogs you probably will be aware that I am not an advocate of radical prostatectomies in any shape, way or form. But since the robot-assisted laparoscopic prostatectomy (RALP) is the flavor of the month with both prostate cancer patients and their urologists, it seems pertinent to zero in on some of the information you need to know if you are considering this procedure.

 

There is something alluring about the idea a surgeon sitting at an attached console and manipulating a robot’s mechanical arms to perform this highly complex and intricate operation. But if you are under the impression that it is the robot making those small incisions in your abdomen to perform the operation, think again. It is the skill of the surgeon that will preserve (or not) your sexual function by avoiding damaging the miniscule nerves that run along each side of the prostate and control erections.  It is the surgeon’s experience that will (or not) protect the sphincter that allows you to retain urinary control. And it is the surgeon’s expertise that will ensure a positive, long-term outcome.

 

RALP has advantages over other forms of radical prostatectomy in terms of pain, blood loss, and recovery time. No small thing. But keep in mind that any complex surgery comes with risks: the small risk of heart-attack, stroke, blood clots in the legs that could travel to the lungs, reactions to anesthesia, and infection of the incision sites. And because there are many blood vessels near the prostate gland, there is also the risk of prolific bleeding, in which case blood transfusions might be necessary—which carry their own risk. But your risk level depends primarily on your overall health, your age, and the skill of your surgical team.

 

Having said that, I realize how tempting it is to go for closure. But is surgery—robotic- assisted or otherwise--really closure? Statistics show that is debatable.  And in terms of the side-effects that most men are concerned about (urinary incontinence and impotence)  there is little difference between robotic-assisted surgery and laparoscopic surgery performed without the robot. Bottom line, the most important factor with either procedure is the surgeon’s experience and skill.

 

Opinions differ about how many robotic-assisted operations a surgeon needs to perform to become really proficient, but surgeons at community hospitals rarely have sufficient experience. And you do not want to be part of a surgeon’s steep learning curve. Dr. Vipul Patel, of the Global Robotics Institute in Celebration, Florida, appears to be leading the pack having performed some 8,000 robotic prostatectomies.

 

It’s apparently hard to resist the lure of a robot. But any kind of radical prostatectomy is both costly and risky, so don’t let your natural desire for closure blind you to the risks of such a challenging surgery—especially if you are 70 or over.  In fact if you have low-risk prostate cancer and are over 65, you have a 20% chance of dying of cancer in the next 20 years compared to a 60% chance of dying of something else. So buyer beware!

The TEAL Shade of Blue

BY MARK SCHOLZ, MD

People assume that the differences in the way prostate cancer behaves—one man develops symptoms and another doesn’t—is because they are seeing different stages of the same illness.  What’s overlooked, often with disastrous consequences, is that these differences are also due to the fact that distinct varieties of prostate cancer exist.

Receiving optimal therapy depends on matching an appropriate treatment with both the correct stage and the correct type of prostate cancer.  Since blue is the color for prostate cancer, as pink is the color for breast cancer, the PCRI has subdivided prostate cancer into five major Shades of Blue. These shades incorporate both the stage and the type of disease. The five shades are SKY, TEAL, AZURE, INDIGO and ROYAL.

The first three shades, SKY, TEAL and AZURE, represent men who have had no previous surgery or radiation. TEAL is what medical professionals call “Intermediate-Risk.” Men in the TEAL shade have identical characteristics to SKY—PSA under 10, Gleason under 7 and a small nodule (or no nodule) on digital rectal examination. However, in addition, men in TEAL have one of the following: PSA between 10 and 20, or, Gleason of 7, or digital rectal exam with a “biggish” nodule confined to one side of the gland.

Since men in TEAL have a small but real chance of cancer spread, staging scans of the bone and body are needed.  In addition, a multiparametric MRI or a Color Doppler Ultrasound should be done to check for spread around the gland just outside the capsule. If extra-capsular disease is seen, the shade changes from TEAL to AZURE.

Treatment for TEAL
The list of treatment options for TEAL is long.  While occasionally men are candidates for active surveillance— particularly those who are older—one of the following treatments is usually administered: Robotic surgery, open surgery, intensity modulated radiation, temporary high-dose seed radiation, permanent seed radiation, a combination of seed radiation and IMRT, proton therapy, Cyberknife, focal therapy or testosterone inactivating pharmaceuticals (TIP).  Sometimes a short course of TIP is combined with radiation.

Focal therapy “focuses” treatment on the cancer itself rather than the whole gland.  Typical tools used for focal therapy are cryotherapy, HIFU or laser. In general, skillfully administered focal therapy is thought to be associated with a lower risk for side effects and only slightly higher risk of future cancer relapse. However, focal therapy is very new and there are relatively few studies accurately describing long-term results.

Another option is to use TIP. TIP causes the cancer to shrivel up.  Typically TIP is continued for six to twelve months after which men are placed on active surveillance.

One general principle is that treatment success depends just as much on the skill of the administering doctor as it does on the type of treatment selected.

The second general principle is that cure rates with most of the different treatments are so close that for comparison purposes, they should be considered identical. Of course, the truth of this principle is predicated on the assumption that all treatments are administered by equally skilled experts.

Side Effects of Treatment
The prostate gland is so close to other critical organs it becomes very difficult to target the gland without damaging surrounding structures. The most common side effects, therefore, are persistent difficulties with sexual, urinary or rectal function.  For example, after radiation in an average 65-year-old, about 75% of men will recover back to their normal pretreatment level of urinary function. About 50% will recover back to their normal pretreatment level of sexual function. After surgery, about 50% of men have urinary function that is restored but only 20% describe their sexual function as recovering back to baseline.

Predictions about the incidence of side effects after focal treatment are less than certain because this technology is so new. Overall, assuming that the treating physicians are skillful, one would expect somewhat better potency rates and somewhat lower cure rates compared to standard surgery or radiation.

Comparing TIP with others options is even more difficult.  Cure rates are certainly much lower. However, the good news is that permanent side effects are rare.  The three most troublesome side effects during therapy are low libido, weight gain and fatigue. Weight gain and fatigue are partially counteracted with diligent diet and exercise. Low libido only resolves after TIP is stopped. Other common side effects such as hot flashes, calcium loss from the bones, mood swings, breast growth and erectile dysfunction can be prevented with medication.

Final Thoughts
Men in the TEAL Shade of Blue, compared to men in the other shades, face the biggest challenge—making a therapeutic choice.  First, there are so many options. Second, none of the options are attractive.  The “best” choice is only relatively better than the others; it’s never something you want to do. Making the best choice for yourself requires good comparison shopping skills, and that requires extensive homework. There are no shortcuts. Third, the biggest differences between the options are not related to the cure rates, it’s the concern about permanent side effects that needs the most attention.

Therefore, my recommendation for selecting treatment is to create a list of all the reasonable choices and study them closely, especially in term of the potential long-term side effects.  The “worst” choices should be eliminated one by one. The last option left on the list will probably be the best treatment for you. 

A Landmark Study: Surgery for Prostate Cancer

BY MARK SCHOLZ, MD

Between in 1994 and 2002, 731 men with an average PSA of 7.8 and age 67 volunteered to have either immediate surgery or observation based on a coin flip. The New England Journal of Medicine reported the 10-year survival statistics this week. What follows is a summary of the statistical outcome of the study.  I think the raw numbers speak for themselves.

Of the 364 who had surgery, 21 men died of prostate cancer.  Of the 367 assigned to observation 31 men died of prostate cancer.  So with observation, the risk of dying was less than 9%.  However, there was still a 6% chance of dying even with immediate surgery.  The net difference between observation and immediate surgery was 3%.

During the first 30 days after surgery there were a number of very serious side effects including one death.  Additionally, there were two men with blood clots in their legs, one stroke, 2 with blood clots in the lungs, 3 heart attacks, 1 man with renal failure requiring dialysis, 10 who required additional corrective surgery, 6 who required additional blood transfusions and 6 who still had urinary catheters more than 30 days after surgery.

Forty-nine men (17%) who had surgery compared to 18 men (6%) who underwent observation “have a lot of problems with urinary dribbling,” some losing larger amounts of urine than dribbling but not all day,” others who “have no control over urine,” and the remainder who “have an indwelling catheter.”

Two hundred thirty one men (81%) who had surgery compared to 124 men (44%) who underwent observation had erectile dysfunction defined as the inability to attain an erection sufficient for vaginal penetration.

Further statistical analysis of a subgroup of men with High-Risk prostate cancer indicated an 8% improved chance of not dying of prostate cancer compared to observation. Also, men who had surgery who were in the Intermediate-Risk or High-Risk category were 10% less likely to develop bone metastases within 10 years compared to the men on observation.

There was no difference in the incidence of mortality or metastases between surgery and observation in the men in the Low-Risk category.

This high-quality study, published in the most prestigious medical journal in the world evaluating the risks and benefits of surgery, required 18 years to perform.  It shows a barely discernible benefit resulting from immediate surgery for men with High-Risk prostate cancer. These findings are quite similar to another large randomized trial of surgery versus watchful waiting that reported 15-year results in the New England Journal of Medicine in May 2011.

The bottom line is very clear:  For men with Low-Risk disease, where surgery is concerned, the treatment is definitely worse than the disease.  Even more striking, is the relatively small survival benefit for surgery in men with High-Risk disease. One can’t help but wonder if the substantial risks of immediate treatment-related side effects outweigh the small benefit in survival.  

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.