In 2000, the da Vinci Surgical System broke new ground by becoming the first robotic surgery system approved by the U.S. Food and Drug Administration for general laparoscopic surgery. In its early years, robot-assisted radical prostatectomy was characterized by some in the surgical community as an expensive technology adopted for its own sake despite a lack of evidence to support its use. However, since then, robot-assisted radical prostatectomy has become the de facto standard of care in the surgical treatment of prostate cancer.
To shed light on the current status of robot-assisted radical prostatectomy and to examine some of the continuing debates in the management of prostate cancer, The ASCO Post spoke with Jeffrey M. Howard, MD, PhD, a surgical urologist who has experience in both approaches to prostate surgery and authored a commentary on this important clinical issue in JAMA Network Open.1
Jeffrey M. Howard, MD, PhD
Integrating Robotics Into Surgery for Prostate Cancer
As a surgeon, please talk a bit about the integration of robot-assisted prostatectomy into the treatment of prostate cancer.
I was in medical school at Baylor College of Medicine, when the surgical robot was still considered a novel approach. During my surgical residency at Brigham and Women’s Hospital in Boston, most radical prostatectomies were done by the open surgical approach. So, I’ve done both approaches, which is increasingly rare these days.
Not surprisingly, robotic surgery was met with a fair amount of skepticism in its early evolution; however, driven by several factors, it has become the most widely used procedure in prostate cancer surgery. In fact, we often get patients who come in and say they want the robotic surgery, not realizing it is more aptly described as a computer-assisted system, where the surgeon sits at a control console during surgery. The console is the control center of the device and allows the surgeon to view the surgical field through a three-dimensional endoscope and control the movement of surgical instruments. Naturally, the lay public likes the comfort zone implied by robotic surgery, in that they may feel it reduces the potential risk of human error. Although there are data supporting certain, if not small, advantages in robotic-assisted radical prostatectomy, there are still several questions and challenges that need to be addressed.
For instance, as I pointed out in my commentary in JAMA Network Open,1 evidence suggests that as for any expensive technology that needs to justify its own cost of acquisition, the mere availability of the robot resulted in it being presented to patients as a superior option, thus further reinforcing its use regardless of any proven clinical benefit. Aside from any controversy surrounding outcomes, robot-assisted radical prostatectomy has been criticized because of the high upfront costs of equipment and consumables, along with aggressive marketing, which has, in fact, created a monopoly by the manufacturers of the da Vinci system. Anytime you have a monopoly, you create potential conflicts, but so far, the system seems to be operating with more pluses than minuses.
What Does Gleason Score 6 Clinically Imply?
Given it is a pathology report that leads to surgery, please give us your opinion on the Gleason 6 score as per its status as a “cancer” and its subsequent therapeutic approach: active surveillance or not?
The Gleason system gives us a statistical sampling of the prostate in a representative manner; with the advent of targeted biopsies, that assumption is no longer completely true. But that’s another related issue.
Over the past decade or so, we have certainly made huge progress in eliminating unnecessary prostate cancer treatments.— Jeffrey M. Howard, MD, PhD
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When you’re talking about Gleason score 6, it implies a Gleason pattern of disease with no Gleason pattern 4. However, it’s important to note that it doesn’t say much about the volume of that disease or any of the other prognostic factors. As you may well know, this issue has not been resolved among the urologic community.
Personally, I tell patients who present with a Gleason score 6 that it is basically not cancer. It’s important to frame the discussion a certain way because many people go into emotional shock at the word cancer, even though we know that even intermediate-risk prostate cancer takes a long time to develop into potentially lethal disease. So, the very mention of the word cancer, in effect, may make it more difficult to suggest active surveillance for patients who should consider it a preferred treatment option.
Most people who favor recategorizing Gleason score 6 are in the urology community, simply because we want to encourage active surveillance. It’s important for patients to understand that a Gleason score 6 presentation has no metastatic potential. However, pathologists are the other half of this dynamic, and they must put their signature on the report that describes the disease; there is often resistance from many pathologists to reclassify Gleason score 6 probably because there is a fair amount of judgment involved. If we say pattern 3 is not cancer, it may put the pathology community in a more difficult position.
That said, I think both sides are missing something. Urologists might not appreciate how difficult it is to make such an important and nuanced finding. On the other hand, pathologists do not sit in front of nervous patients trying to convince them not to undergo a morbid treatment, even though they are programmed by the “get it all out” impulse when it comes to cancer.
It will take a lot more effort to educate and convince low-risk patients to try active surveillance. In that doctor/patient discussion, it might be useful to mention the medical community is debating whether to reclassify a Gleason 6 score as cancer; the fact that there’s an ongoing debate about reclassifying it as a cancer may help ease patient anxiety and hopefully lead to a rational decision-making process. So, there’s still a lot of work to be done on this important clinical issue. However, over the past decade or so, we have certainly made huge progress in eliminating unnecessary prostate cancer treatments.
Level of Evidence for Surgical Approaches
About 85% of radical prostatectomies are now performed via robot-assisted means. However, as some leaders in surgical urology have pointed out, there are limited rigorous long-term cancer control data on robotic surgery. What are your thoughts on this?
The nature of medical evidence is structured differently in surgery. We always want level one evidence, in which we randomly assign patients to protocol A or B and measure the difference in outcomes. Those types of trials, however, are super difficult to conduct in the surgical setting for various reasons, such as a higher degree of heterogeneity among techniques and varying proficiency among surgeons.
However, when it comes to prostatectomy, studies have looked at robotic surgery outcomes vs open and laparoscopic approaches. As I noted in my commentary in JAMA Network Open, the previous high-level evidence has suggested only minimal (if any) long-term benefit to robot-assisted radical prostatectomy compared with open radical prostatectomy when both are performed in expert hands. And studies have also shown a slight advantage with robot-assisted radical prostatectomy regarding erectile dysfunction. However, I think we need to look at the reality of the bigger clinical picture: Robot-assisted radical prostatectomy was introduced about 20 years ago and have now become, in most instances, the first option for patients undergoing the procedure.
Robot-assisted radical prostatectomy is here to stay, and over time, like all technologies, it will become more effective.— Jeffrey M. Howard, MD, PhD
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More important, if you were to poll the current body of urologic oncology surgeons, you’d find there is now near-uniform approval of the value of robot-assisted surgery. So, it’s here to stay, and over time, like all technologies, it will become more effective. Other issues such as vendor lock-in and cost-effectiveness will still be debated, but as surgeons, that’s not within our purview—outcomes are.
Shifting Sands of Prostate Cancer Management
Please share your thoughts on the evolution of prostate cancer detection and treatment.
I think the one-liner on this is that everything in this clinical space is changing all at once. So, it becomes difficult to know what to do with an individual patient because the assumptions upon which we’re building our management may no longer be true.
One example of that is the Gleason score. The entire system of 3+4 or 4+3 or 4+4 derives from a paradigm in which the prostate is biopsied using a template that is supposed to represent a systematic sampling of the gland to guide treatment decisions. But now, we’ve put a finger on the scale with the advent of targeted biopsies. These targeted biopsies will enrich pattern 4 disease at the expense of pattern 3 disease; on a population scale, this will push more patients in the direction of treatment. That’s one problem that no one has yet figured out.
This is just one example of many issues that will pose challenges as we move forward. However, it is abundantly clear that we have made great strides in the detection and management of prostate cancer, and I’m excited to be part of a field that holds so much promise for the future.
DISCLOSURE: Dr. Howard reported no conflicts of interest.
1. Howard JM: Robotic, laparoscopic, and open radical prostatectomy: Is the jury still out? JAMA Netw Open 4:e2120693, 2021.