Those are the main findings that we saw, but we also looked at global quality-of-life measures, things like physical function—ability to do daily activities, emotional function, and a domain called "energy" or fatigue. There were no differences between groups in those domains. And what that tells us is that men seem to deal with the side effects of treatment without infringing on their general quality of life. Obviously, the domains of sexual function, urinary function, and bowel function are important to people, but in large part they did not seem to have a great impact on the emotional wellbeing or ability to perform their daily activities.
In your practice, have you seen an increase of patients opting for active surveillance?
That is a very important question, and is one that transcends the practice level. The short answer is, yes, definitely—and it is something that is happening nationwide. There is no doubt that urologists are recommending active surveillance increasingly for men with low-risk disease and/or men with a limited life expectancy. That is demonstrated daily in our practice but has also been shown in several different studies that both we and others have published. There is a trend toward increasing the utilization of active surveillance in the appropriate settings. I think too often we were overtreating, and I think treatment is decided more sensibly and judiciously these days.
In the state of Michigan, there is a urology collaborative called MUSIC, and they are showing utilization of active surveillance in about 50% among me with low-risk disease. We did a study in the SEER-Medicare Linked Database showing the rising trend of the use of active surveillance in low-risk patients. We did another study using this CEASAR cohort and comparing it to an older cohort that was accrued in a similar fashion, through the SEER registry. I am very encouraged by these studies on long-term oncologic outcomes of active surveillance, which have been very favorable—very few people die of prostate cancer using that strategy and if we can safely keep men away from the side effects of treatment, we are doing them a favor.
Our study did not show any difference in survival—but it wasn’t intended to show that. For that, you would need to look at much longer follow-up and there are not many good studies that have done that. One randomized trial followed men after 10 years—most of them had low-risk disease and so you wouldn’t expect to see differences in survival because it is relatively low follow-up and mortality events are very uncommon in men with low-risk disease. The other studies we have are not randomized, they are old observational studies using older techniques. Those make surgery look better and I am not sure if that is a fair comparison or not, and I'm not sure if it is still true today with more modern radiation techniques—we usually think of them as neutral, as equally effective. The point that I am making is that some folks believe that surgery may be a more effective or definitive treatment than radiation, and some men might find those side effects acceptable or tolerable if they have more aggressive disease.
What message do you think community oncologists need to know about active surveillance?
I think it is a safe alternative for men with favorable disease characteristics. There are pretty specific criteria that we use to recommend active surveillance in terms of having low-risk disease features. It is a nuisance for the patient in the term of repeat testing and biopsies, and there is a potential for patients having some uncertainty or anxiety about living with a cancer that is being observed. But again, the evidence shows that this is a safe strategy. Patients have to accept the possibility of disease progression while they are on active surveillance; although the likelihood of that happening is very low, it is not zero. There is some acceptance of risk on the part of the patient, but typically that risk of disease progression is small compared to the risk of side effects from treatment that they may not need. So, when it is presented to patients in the right way, they seem to understand and accept it.
One additional thought—and this is anecdotal—is that I find patients accept active surveillance more readily if they have been counseled before biopsy. If they have been counseled before the biopsy, the biopsy could come out 1 of 3 different ways: it could be negative; positive for a clinically significant cancer that we need to treat; or it could come out in this middle ground—a low-grade cancer that can probably be safely observed, which are the cancers that most men will develop over their lifetime and usually do not spread or effect lifespan. If they hear that before the biopsy, then they are less surprised when you talk to them about active surveillance afterward.