ACS guideline:
Beginning at age 50, asymptomatic average-risk men with at least a 10-year life expectancy should receive information that allows them to make an informed decision, in collaboration with their healthcare providers, about prostate cancer screening

Despite the clear fact that PSA is the most accurate single cancer detection test in oncology, recent complaints about false positive test results (as occurs with all tests) and an inability to differentiate the most dangerous prostate cancers has the ACS backtracking on its prior pronouncements.  The America Urological Association (AUA) and the ACS are no longer in agreement about who should be screened.  This is a complex issue that even the experts do not agree, making it even more puzzling that the ACS is abdicating its leadership role and now wants to leave this controversy up to the patient.

Screening technically refers to testing an individual with no signs, symptoms or risk factors for a particular disease.  Thus screening recommendations should not be taken to dissuade testing of men with lower urinary tract voiding complaints or a family history of prostate cancer.  Most people have had their cancer for many years before it is detected regardless of the type of cancer.  A down side of early detection is that a tiny cancer found may never have caused the individual any problem in their lifetime thus subjecting them to unnecessary testing and treatments.  We clearly need to do more research in this area to better predict the lethality of a cancer in any specific individual case.  Yet we cannot forget that it is early detection, when a cancer is still just a small clump of cells that has allowed us to eradicate the cancer and maintain a person’s functional quality of life.  Today we rarely do a true radical prostatectomy anymore.  A nerve sparing prostatectomy is better described as a total prostatectomy because we do not take a lot of tissue surrounding the prostate as we did in the past.  This allows us to dramatically improve urinary control and erectile function results.  It is similar to our experience with breast cancer.  Twenty-five years ago a radical mastectomy was the standard of care.  Today, because of early detection (mammography and self examination), we are able to successfully eradicate the cancer in many women with a lumpectomy and preserve most of the breast.  I believe it is always better to know about the cancer than not.  An individual can always op for surveillance and delay treatment if they so desire.  Once the cancer is beyond a certain point, cure is limited.  However, with careful close monitoring an individual may avoid unnecessary treatment without unnecessary risk of advanced disease.

The ACS guidelines further advise against a DRE.  The DRE should remain a routine part of a comprehensive physical examination.  Not only can it pick up the 20% of prostate cancers which present with a normal PSA but can help detect rectal carcinomas, hemorrhoids and other anal lesions.

The add directs you to a web site which attempts to get your email address in addition to other demographic data.  You are then sent a very well produced color brochure describing what ProstRcision® entails.  After reading the pamphlet, one gets the impression that the RCOG are a research foundation rather that just a large radiation therapy group out of Decatur Georgia.  It sounds as though they invented this technique, which they did not or that they are doing something truly unique, which they are not.  I have confirmed this with a Professor of Radiation Therapy at the University of Louisville Brown Cancer Center.  RCOG appear to base most of their claims on a single publication by one of their physicians that reviews their results of combination radiotherapy in men treated with 5 or more years of followup.  They state that their table of comparisons to other treatment modalities is “an apples-to-apples comparison of cure rates” which in my professional opinion it is not.  They promote an Individual Cure Rate or ICR based on six clinical parameters which they claim “provides you with a precise chance of being cured”.  Their ICR claims over simplify the complexity of predicting outcomes with a particular treatment for prostate cancer.  No clinician can precisely predict how any individual patient’s treatment will turn out, mainly because prostate needle biopsies can frequently under stage and under grade the patient’s cancer.  Only after surgical removal of the entire prostate and lymph node dissection do you have a reasonably accurate pathological staging of your cancer and even that can sometimes be wrong.

Combination radiotherapy utilizing seed implantation followed by external beam radiation is a sound approach to treating men with clinical low grade, low stage prostate cancer in men with small prostates and minimal pre-treatment voiding complaints.  It can result in complications of impotence and incontinence, like all other modalities in addition to more serious problems like rectal injury, fistulas or scarring of the bladder neck.  Surgical removal of the prostate is generally not an option for men who have failed this type of radiation treatment.  I am unable to find any peer reviewed articles in the medical literature which claim ProstRcision® has the highest documented cure rate.

Since I first put up this post I was contacted by a law firm representing the Radiotherapy Clinics of Kentuckian (RCOK).  They are apparently affiliated with RCOG and threatened me with a law suit if I did not remove the article from my website. I am not implying any intentional misrepresentation by either RCOK or RCOG.  This is my professional opinion after reading through their literature.

February 14, 2010

Results Unproven, Robotic Surgery Wins Converts

By GINA KOLATA

At age 42, Dr. Jeffrey A. Cadeddu felt like a dinosaur in urologic surgery. He was trained to take out cancerous prostates the traditional laparoscopic way: making small incisions in the abdomen and inserting tools with his own hands to slice out the organ.

But now, patient after patient was walking away. They did not want that kind of surgery. They wanted surgery by a robot, controlled by a physician not necessarily even in the operating room, face buried in a console, working the robot’s arms with remote controls.

“Patients interview you,” said Dr. Cadeddu, a urologist at the University of Texas Southwestern Medical Center at Dallas. “They say: ‘Do you use the robot? O.K., well, thank you.’ ” And they leave.

On one level, robot-assisted surgery makes sense. A robot’s slender arms can reach places human hands cannot, and robot-assisted surgery is spreading to other areas of medicine.

But robot-assisted prostate surgery costs more - about $1,500 to $2,000 more per patient. And it is not clear whether its outcomes are better, worse or the same.

One large national study, which compared outcomes among Medicare patients, indicated that surgery with a robot might lead to fewer in-hospital complications, but that it might also lead to more impotence and incontinence. But the study included conventional laparoscopy patients among the ones who had robot-assisted surgery, making it difficult to assess its conclusions.

It is also not known whether robot-assisted prostate surgery gives better, worse or equivalent long-term cancer control than the traditional methods, either with a four-inch incision or with smaller incisions and a laparoscope. And researchers know of no large studies planned or under way.

Meanwhile, marketing has moved into the breach, with hospitals and surgeons advertising their services with claims that make critics raise their eyebrows. For example, surgeons in private practice at the New Jersey Center for Prostate Cancer and Urology advertise on their Web site that robot-assisted surgery provides “cancer cure equally as well as traditional prostate surgery” and “significantly improved urinary control.”

Robot-assisted prostate surgery has grown at a nearly unprecedented rate.

Last year, 73,000 American men - 86 percent of the 85,000 who had prostate cancer surgery - had robot-assisted operations, according to the robot’s maker, Intuitive Surgical, the only official source of such data. Eight years ago there were fewer than 5,000, Intuitive says.

Dr. Sean R. Tunis, director of the Center for Medical Technology Policy, a nonprofit organization that evaluates medical technology, said few other procedures had made such rapid inroads in medicine.

Medical researchers say the robot situation is emblematic of a more general issue. New technology has sometimes led to big advances, which can justify extra costs. But often, technology spreads long before investigators know whether it is worthwhile.

With drugs, the Food and Drug Administration requires extensive tests to determine safety and efficacy. But surgeons are free to innovate, and few would argue that surgery can or should be held to the same standards as drugs. Still, a situation like robot-assisted surgery illustrates how patients may end up making what can be life-changing decisions based on little more than assertive marketing or the personal prejudices of their surgeon.

“There is no question there is a lot of marketing hype,” said Dr. Gerald L. Andriole Jr., chief of urologic surgery at Washington University. Dr. Andriole does laparoscopic prostate surgery, and although he tried the robot, he went back to the old ways.

“I just think that in this particular instance, with this particular robot,” he said, “there hasn’t been a quantum leap in anything.”

Evaluating technology is complicated. As often happens in surgery, doctors can become enthusiasts without rigorous studies ever being done.

And with prostate cancer, more is at stake than just an academic dispute, said Dr. Jason D. Engel, director of urologic robotic surgery at George Washington University Medical Center in Washington. One in six American men develop prostate cancer in their lifetime. Treatment options include radiation and watchful waiting, but the most popular is surgery.

“With the stream of prostate cancer patients that come through,” Dr. Engel said, “this is a big, big business.”

Dr. Michael J. Barry, a professor of medicine at Massachusetts General Hospital in Boston, said that once a hospital invests in a robot - $1.39 million for the machine and $140,000 a year for the service contract, according to Intuitive - it has an incentive to use it. Doctors and patients become passionate advocates, assuming that newer means better.

“Doctors and medical centers advertise it, and patients demand it,” Dr. Barry said, creating a “folie a deux.”

The robot’s ability to reach into small spaces comes with tradeoffs. Ordinarily, doctors can feel how forcefully they are grabbing tissue, how well they are cutting, how their stitches are holding. With the robot, that is lost. And the robot is slow; it typically takes three and a half hours for a prostate operation, according to Intuitive, twice as long as traditional surgery.

A few highly experienced doctors are much faster. Dr. Vipul Patel, for example, at Florida Hospital in Celebration, Fla., has done more than 3,500 robot-assisted prostate surgeries. He often does six a day, taking about one and a half hours for each.

“From Day 1, when I sat down at that robotic console, I knew we would give patients a better outcome,” Dr. Patel said. “I have not seen anyone who has done a good amount of robotic surgery go back.”

Dr. Patel also started The Journal of Robotic Surgery to provide a forum, he said. Dr. Engel said he and others who use robots welcome it. They had had difficulty getting published in traditional journals, Dr. Engel said.

But papers in the new journal tend to report on one surgeon’s experience. Studies like that, which were also published in the past to promote traditional surgery, have methodological problems - biases in patient selection and evaluation are likely and, because the surgeons tend to be much better than average, it is hard to generalize.

In contrast, the national study of Medicare patients from 2003 to 2007, by Dr. Jim C. Hu of Brigham and Women’s Hospital in Boston, included 6,899 men who had surgery with four-inch incisions and 1,938 who had laparoscopic surgery, many with a robot.

The study was not ideal - patients were not randomly assigned to have one type of surgery or another, and laparoscopic operations done without a robot were included with the robot-assisted ones because Medicare did not distinguish between the two. But it is the only large national study that compares what is thought to be a largely robot-assisted surgery group with a group that did not have a robot.

The paper, published last October in The Journal of the American Medical Association, found that laparoscopic surgery patients had shorter hospital stays, lower transfusion rates and fewer respiratory and surgical complications. But they also had more incontinence and impotence.

It is not known whether the extra costs of robot-assisted surgery are balanced by lower costs for shorter hospital stays and fewer surgical complications.

Experts in robotic surgery say studies like Dr. Hu’s can be misleading. Medicare data, they say, include results from surgeons who may have little experience with robots.

Dr. Barry, an author of Dr. Hu’s paper, said Medicare data reflect the real world. “Everyone tends to cite data from centers of excellence as though they were their own,” he said.

Highly skilled surgeons, like Dr. Ashutosh K. Tewari at Weill Cornell Medical College in New York, say it takes about 200 to 300 robot-assisted operations to become highly proficient. Dr. Tewari has done 3,200.

Surgeons who do nonrobotic prostate surgery agree.

“What happens is that if you take leading experts, whether they do open or robotic, they are going to get good results,” said Dr. Herbert Lepor of New York University, who has done more than 4,000 traditional open prostatectomies.

“I say robotic surgery has to be better to justify its learning curve,” Dr. Lepor said, “to justify its unknown cancer control, to justify its increased cost.”

Both traditional surgeons and those who do robot-assisted surgery point to patients who did extremely well.

Among them is James Lamb, a 40-year-old New York City police officer who had robot-assisted surgery with Dr. Tewari on Jan. 5. Two days later, while he was in the hospital and still had a catheter in his penis, Officer Lamb had an erection.

Two days after that, Officer Lamb said, he was home and had sexual intercourse. (In one study by Dr. Barry, which surveyed patients a year after surgery, only half the men, regardless of surgical method, were back to their presurgery potency a year later, with or without the use of a drug like Viagra.)

But, Dr. Barry and Dr. Tewari note, an extraordinary patient or two can be misleading. “The message for patients is not to assume that newer is better,” Dr. Barry said. Measures like the number of operations a surgeon has done “still matter a lot,” he said.

Dr. Cadeddu, though, said that sort of message is falling on deaf ears. Patients want the robot. So Dr. Cadeddu has now begun offering robot-assisted surgery to those who want it.

“The battle is lost,” Dr. Cadeddu added. “Marketing is driving the case here.”

Radiation Offers New Cures, and Ways to Do Harm

As Technology Surges, Radiation Safeguards Lag

Status of Radical Prostatectomy in 2009:  Is There Medical Evidence to Justify the Robotic Approach?

Herbert Lepor, MD
New York University School of Medicine, New York, NY

This article presents the evolution of open radical retropubic prostatectomy (ORRP) into a minimally invasive procedure and reviews the literature to provide a legitimate comparison between ORRP and robotic-assisted laparoscopic radical retropubic prostatectomy (RALRP). The article is limited to manuscripts cited in the peer-reviewed literature, and an effort was made to identify those articles that fulfilled the highest level of medical evidence. In centers of excellence, ORRP is performed with no mortality, extraordinarily low technical and medical complications (1%), the rare need for blood transfusions, 1 to 2 day hospital stays, urinary catheters that are routinely removed in a week, the majority of men returning to work in 2 weeks, and up to 97% of men regaining urinary continence.  Return of potency remains a challenge, especially for older men with marginal erections. RALRP is now the most common approach for the surgical removal of the malignant prostate. A critical review of the literature fails to support the marketing claims that RALRP is associated with shorter hospitalization, less pain, better cosmetics, shorter catheter time, lower transfusion rates, or improved continence and potency rates.  The highest level of medical evidence suggests that RALRP may significantly compromise oncologic outcomes and that men undergoing this approach have higher regret rates than men undergoing ORRP.
[Rev Ural. 2009;11 (2}:61-70]

Dr. William J. Catalona

Chicago, Illinois

Patients contemplating radical prostatectomy for prostate cancer want the answers to many important questions.  Will I be cured of my cancer? Will I be continent? Will I be able to have spontaneous erections?  What is my risk for other complications? How long will it take to return to my regular activities?  Open nerve sparing radical retropubic prostatectomy is the gold standard for the surgical treatment of prostate cancer, and the answers to these questions are well documented for open prostatectomy. The results have shown that high volume surgeons usually achieve excellent outcomes. Recently largely due to hype and aggressive marketing, there has been increasingly widespread use of robot assisted laparoscopic radical prostatectomy in the United States.¹   Reports directly comparing open and laparoscopic procedures are just beginning to be published because of the relatively recent use of laparoscopic operations to treat prostate cancer. However, during the last year several highly credible studies on comparative data have indicated important disadvantages of these minimally invasive approaches in terms of achieving cancer control, urinary continence and patient’s satisfaction.^2-4  Furthermore, recent studies have called into question whether robotic surgery offers any material advantage in terms of side effects or recovery time.^5,6   These comparative studies are more informative than reports merely claiming that laparoscopic or robotic surgery has significant advantages compared to open surgery.

Using a sample of the Medicare database, Hu et al compared open and  minimally invasive surgery  from 2003 to 2005.  Men undergoing minimally invasive surgery were more than 3 times (27.8% vs 9.1 %) more likely to require treatment for tumor recurrence within 6 months. For those men treated by low or medium volume minimally invasive surgeons, the need for further treatment for tumor recurrence ranged from 40% to 32%, respectively.  However, even those patients treated by the highest volume minimally invasive surgeons were more than twice as likely (19%) to require salvage therapy as those treated by all open surgeons combined (9%).  Although there were significantly fewer medical complications (cardiac, respiratory, vascular etc) with minimally invasive surgery, the need for a subsequent procedure to remedy a surgical complication such as anastomotic stricture was 40% higher. These results call into question whether all patients with prostate cancer are receiving high quality care in this country. 

Touijer et al reported that patients treated by a leading expert in laparoscopic surgery were less likely to regain urinary continence than those treated with open prostatectomy.³ Patients who underwent laparoscopic surgery also had a higher rate of emergency room visits, hospital readmissions and further surgery for complications.  Schroeck et al reported that patients who chose robotic prostatectomy were 4.45 times more likely to regret their decision than those treated with open surgery, possibly because of the higher expectations associated with an innovative procedure.⁴

Do laparoscopic and robotic approaches even offer patients a quicker, less painful path to recovery?  Nelson et al reported that patients treated with robotic or open surgery recovered on essentially the same clinical pathway.⁵  Similarly Wood et al reported that short-term recovery after discharge home including time to normal and full activity, driving and post-discharge narcotic use, was comparable between robotic and open procedures.⁶ 

With laparoscopic and robotic surgery there is generally less blood loss, but when bleeding occurs it cannot be controlled as quickly without thermal energy as it can with open surgery. Therefore, ultrasonic shears or electrocautery is frequently used by many laparoscopic surgeons in or near the neurovascular bundles to stop the bleeding.  However, hemostatic energy sources can irreversibly damage the neurovascular bundles. Thus if the dissection is carried widely to encompass the cancer, the nerves get cooked, and if the dissection is carried too medially in attempting to spare the nerves, there is a risk of cutting into the prostate or, worse, leaving behind prostate tissue and tumor. 

Other disadvantages of robotic surgery also come into play such as the lack of tactile feedback and inferior global visualization. In addition, the transperitoneal approach to robotic prostatectomy is more invasive than the extraperitoneal approach with open surgery, and there is a greater risk of vascular, bowel and ureteral injury as well as intraperitoneal adhesions that predispose to subsequent intestinal obstruction. The 6, 1-inch incisions (with 1enlarged to extract the prostate) used for robotic prostatectomy in contrast to a single 4 to 5-inch incision with open prostatectomy beg the question of superior cosmetic results with robotic surgery. Thus despite the overstated claims and widespread use of robotic prostatectomy, it is far from established that the laparoscopic or robotic approach is as safe an operation for cancer as classic open prostatectomy, or that nerve sparing can be as readily or safely accomplished. 

The marketing and hype of robotic prostatectomy have not fooled all of the people all of the time. New York Times columnist Tara Parker-Pope commented on the report of Schroeck et al in her blog “Well,” writing, “The research … is the latest to suggest that technological advances in prostate surgery haven’t necessarily translated to better results for men on which it is performed. It also adds to growing concerns that men are being misled about the real risks and benefits of robotic surgical procedures used to treat prostate cancer.”^4,7

In the short term the holy grail of the trifecta for patients with prostate cancer, including cancer cure, potency and continence, is driven primarily by continence and potency. In the long term cancer control is the big issue. If the cancer comes back salvage radiation or hormonal therapy can nullify any early gains in potency achieved at the expense of complete tumor excision.  Therefore, the most important and as yet unanswered question is what will the prostate specific antigen recurrence rate be 10 years after surgery?

The jury is still out with laparoscopic and robotic prostatectomy. Time will tell but to date much of the important evidence leaves claims of superiority to or even of equivalence with open prostatectomy in doubt.

I. Eastham JA: Robotic-assisted prostatectomy: is there truth in advertising? Eur Urol 2008; 54:720.

2. Hu TC, Wang Q, Pashos CL et al: Utilization and outcomes of minimally invasive radical prostatectomy. J Clin Oncol 2008; 26:2278.

3. Touijer K, Eastham JA, Secin FP et al: Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005. J Urol 2008; 179: 1811.

4. Schroeck FR, Krupski TL, Sun L et al: Satisfaction and regret after open retropubic or robot-assisted laparoscopic radical prostatectomy. Eur Uro1 2008; 54:785.

5. Nelson B, Kaufman M, Broughton G et al: Comparison of length of hospital stay between radical retropubic prostatectomy and robotic assisted laparoscopic prostatectomy. J Urol 2007; 177: 929.

6. Wood DP, Schulte R, Dunn RL et al: Short-term health outcome differences between robotic and conventional radical prostatectomy.  Urology 2007; 70: 945.

7. Parker-Pope T: Regrets after prostate surgery. In: Well: Tara Parker-Pope on Health. The New York Times, August 27, 2008.