Can we use prostate cancer to develop national trial registry systems?

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?

6 Responses

  1. It’s disappointing to me that there seems to be no national database of the sort anticipated here. Such would obviously have significant potential for use in critical research. Why not?

  2. Grover:

    Two basic reasons … (1) the cost, which would be huge; (2) the politics, which would be complicated. Of course this doen’t mean we shouldn’t do it, but it does mean that we are highly unlikely to be able to get our act together!

  3. Dear Sitemaster,

    Thanks for your reply. I understand that there would be cost. I presume that the cost would be borne, at first, by physicians (their offices), providing their reports online. But they must be keeping such digitized data, now, on their own patients. This would become standardized, nationally, at a savings. A computer program would gather, organize, tabulate, and make the results available for a fee. And wouldn’t the fees pay for the cost? Seems to me that NIH would pay for a pilot program on, say, prostate cancer.

    Sorry to bother you with this reply. I can’t imagine you have time for much of this. No doubt you understand these matters better than me. But it seems to me a matter of interest. As I mentioned, I have been disappointed that there seems to be so little quantification of data, inputs and outcomes, against which I could compare my own case. I’m supposing such possibility would have a health value. Maybe I am not accessing the information in fact available.

    Thanks again.

  4. Dear Grover:

    The problem is that physicians do not like to keep “standardized” data. They like to collect the data that they think is valuable (which, in their opinions, can be a whole different thing). And if you think that most physicians in thsi country are using computer-based, electronic medical records already, please let me disabuse you of that idea. They aren’t, so the collection, management, and submission of all such data into a national database (which many physicians wouldn’t even consider doing without getting paid for it) is going to be a big problem.

  5. In no way was I suggesting that a urology-led registry should only focus on patients undergoing surgery for prostate cancer. Rather, I was suggesting that, as the providers who claim to be the doctors who are primarily responsible for diagnosing and managing prostate cancer, urologists need to be the ones who take the lead in establishing such a comprehensive registry that engages all stakeholders. We will see if the specialty is up to the task.

    I will add, however, that such registries and studies already exist and often are ignored by providers, patients, and policymakers. I am refering specifically to the CAPSURE disease registry and the Prostate Cancer Outcomes Study (PCOS). Both projects contain patient-centered data and have longitudinal follow-up for all treatment modalities. PCOS has the advantage of being population-based, CaPSURE has the advantage of being very large and more flexible because it is a true registry. I haven’t even mentioned the PROST-QA study which also has some value.

    Having pointed these incredibly valuable resources out, I have to say I am constantly shocked by how results from these projects are ignored by the very stakeholders who could gain the most benefit from them. No one quotes patient-reported outcomes from CaPSURE or PCOS to their patients. In fact, I have no doubt that someone will reply to this post by saying that those cohorts are historical because they don’t include IMRT, or proton-beam or robotic surgery or HIFU or whatever the latest, greatest technology is (and almost always is shown to be a marginal improvement at best over existing techniques when it is properly studied).

    My point is that, regardless of whether it is the AUA, ASTRO, PCORI, AHRQ, or whoever leads a registry, it is time for the stakeholders — specifically the patients, but also the payors and policymakers — to start to pay attention to the results and not be swayed by fancy marketing and unrealistic claims. Changing the way healthcare is reimbursed is beyond the scope of a registry. Helping patients to make smart and informed decisions is not.

  6. Dear Dr. Penson:

    Thank you very much for your clarifications.

    I would only note that if newly diagnosed patients are not made aware of the data from the current registry studies (CaPSURE, PCOS, etc.) by their physicians at the time of their diagnosis and discussion of their clinical options, the chances are high that most patients will never find out about such data until long after they have made a decision. As much as it is time for the patients, the payors, and the policy makers to pay attention the the data that are currently available, I hope you would agree that it is also time for the AUA, ASTRO, PCORI and AHRQ to collaborate seriously on the development of the treatment-neutral registry that you describe (specifically inclusive of data on active surveillance/monitoring).

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