The April issue of AUA News (a magazine only available to AUA members) includes an interesting article by David Penson, MD, in which he previews a lecture he will be giving at the upcoming annual meeting of the American Urological Association (in Atlanta, later this month).
The AUA has given Dr. Penson a platform to make a point that other members of the prostate cancer community have been making (on and off) for years:
As urological surgeons, we have spent the last 30 years arguing that surgery is superior to radiation or observation to treat [clinically localized prostate cancer]. However, as a specialty, we have not completed adequately sized, randomized clinical trials or properly risk adjusted observational studies that definitively support our contentions. Our inability to generate credible evidence to support our practices has led other to do the studies for us with results that many urologists take exception to.
Quite correct Dr. Penson. So what should the urology community do about this?
… now is the perfect time for our specialty to take the lead in identifying effective therapies for urological conditions and improving urological quality of care through data collection. There is a critical need for us to measure outcomes by creating large clinical data registries that go beyond existing administrative data sets, such as Medicare or SEER … -Medicare, and collect detailed patient level clinical information that can be used for better risk adjustment and more accurate assessment of outcomes.
Clearly Dr. Penson is including prostate cancer outcomes data in these registries. Unfortunately, data that are limited to urologic surgery outcomes in prostate cancer are only half of the battle. What are really needed are registries of the type Dr. Penson describes that are cross speciality where appropriate. In other words, in the case of clinically localized prostate cancer, we need a registry that contains standardized baseline and outcomes data regardless of treatment type, so that older forms of treatment can be compared to newer versions of that treatment (IMRT vs. PBRT) and so that very different forms of treatment can be compared to each other (CyberKnife radiation vs. high-intensity focused ultrasound [HIFU]).
In saying this, we are not disagreeing with Dr. Penson’s premise that it is time for urologists to “step up to the plate” and actually demonstrate that what they claim is actually true. We are only saying that “truth” will require data that are not limited to the outcomes achieved by urologists when it comes to clinically localized prostate cancer. “Truth” is going to require a nationally operable, cross-specialty registry system. With such a system in place, for example, we could probably have been able to give preliminary approval to the use of HIFU for the treatment of clinically localized prostate cancer — with the understanding that all patients so treated over the first 10 years would be required to have data entered into the registry according to a standardized proctocol … with complete and appropriate follow-up for (at least) 10 years — or longer.
Double-blind, randomized clinical trials are highly appropriate ways to test whether some new forms of therapy are safe and effective compared to current standards of care (particularly where systemic drug therapy is under consideration). In other cases, standardized registry studies may be just as effective. Clinicians, patients, and device manufacturers would understand that new treatment X had been given preliminary market approval subject to the need to collect relevant data in well-defined sets of patients. Failure to demonstrate that the new treatment was as effective or as safe as the normal standard of care would simply result in a recommendation that the cost of such care not be covered. People could still get it if they wanted it, but they would have to pay for it themselves. Why should “society” as a whole be paying for a treatment that doesn’t work well in the defined target patient group?