Time for a new approach to urologic research on prostate cancer?

With the conclusion of the AUA annual meeting in San Francisco and the opening of the annual meeting of ASCO in Chicago, your correspondent has once again noted some core differences in the ways the oncology community and the urology community seem to approach their research agendas.

At the AUA meeting there must have been well over 600 new papers and presentations on prostate cancer over the course of 5 days (quite apart from all of the educational courses and opinion-based debates). However, relatively few of these presentations provided new data from prospective, multi-center, randomized clinical trials that could hope to offer category 1, practice-changing (or practice confirming) evidence about the management of prostate cancer. Where such data were presented, it was usually because the studies had been funded by commercial pharmaceutical, medical device, or diagnostics companies that need to conduct such trials in order to gain regulatory approval for a new drug, a new form of treatment, or a new diagnostic test. The vast majority of the data presented was based on prospective and retrospective analysis of single-institution (and sometimes multi-institution) patient series.

Now we should be clear that data from some of these single- and multi-institution patient series are extremely important, because they may refine thinking or they may generate new hypotheses that need to be tested. However, what still seems to be missing is a community mindset among urologists that they really need to be cooperating in the design and implementation of the types of large, prospective, multi-center trials and registry studies that can really help to define best practices in an increasingly complex and opinion-driven clinical setting. Let us offer one simple example of where such a multi-center trial might be really helpful.

For several years there has been an intense debate over the value of PSA velocity as an indicator for the risk of prostate cancer in undiagnosed patients. There is little doubt that PSA velocity is helpful in at least a very small subset of patients. However, there are strong suggestions that PSA velocity has little to no relevance in the case of the majority of patients. The National Comprehensive Cancer Network guidelines continue to recommend the use of PSA velocity. Yet there has most certainly been no good prospective clinical study, carefully structured to address things like patient age and other important baseline factors, and using rigorous criteria for how and how often PSA testing is carried out, that truly would confirm or deny the value of PSA velocity as an indicator of risk for prostate cancer. It would not seem to be too difficult to conduct such a study using a well-defined registry system. What is required as the priority is a willingness among the opinion leaders to put the needs of patients first (i.e., ahead of their individual research agendas) and work together to design and implement a really good study to address this issue.

The oncology community — by comparison, and in general — is much more used to the idea of the cooperative group and multi-center trial. This does not mean that there aren’t all sorts of small retrospective analyses and single-institution studies, but every year at ASCO there are reports of major, practice-changing trials. These aren’t all in prostate cancer, of course, but our point is that the oncology clinical research community certainly appears to be more understanding of the need for cooperation between centers.

The recent focus on the need for what has been termed “comparative effectiveness research” into the relative benefits of differing treatment options in medicine may help to drive some badly needed trials in urology. It may also help to drive the development of some very poorly designed trials that actually prove very little. Your commentator is certainly not smart enough to appreciate all of the issues that need to be addressed in the development and implementation of large, multi-center studies on the management of prostate cancer. However, he does believe that we will not solve some of the most fundamental issues in the management of this disorder until we are willing to bring a more cooperative mindset to the execution of practice-defining studies in this field. We clearly have the ability to do this. We have shown this through trials like the Prostate Cancer Prevention Trial, the SELECT study, and others that involved hundreds of doctors and their patients across the USA. It seems to us that there is a major leadership opportunity here for someone or some organization.

2 Responses

  1. Perhaps this quote from The New England Journal of Medicine (July 31, 1997; Vol. 337, No. 5) is pertinent:

    “The many recent changes in therapeutic approaches to localized prostate cancer are exciting and preoccupying but to patients they are bewildering and can seem dangerous. Until the trials now under way have been completed, we have no firm guidelines for advising our patients about which therapeutic option is best. This means that education is more important than ever, but the art of multidisciplinary counseling is hampered by rivalries that seem more common among prostate-cancer specialists than in other cancer specialties. This must change. The necessity for cooperation between surgeons and radiation therapists in treating men by brachytherapy is one bridge that can link disciplines. Close collaboration between surgeons, radiotherapists, and medical oncologists is mandatory for substantially improved control of prostate cancer.”

    Seems to me that very little has changed in the 13 years since that was written. Why aren’t oncologists involved in earlier stages of treatment decisions. They are usually only consulted when primary treatment has failed or the diagnosis comes too late in the day. I understand that is not the case for other cancers — notably breast cancer. Should activists be focusing on this issue more than they do?

  2. This Sitemaster has made a significant contribution to furthering our knowledge re PSA and prostate cancer and deserves a huge thanks.

    Recently, I have noticed more editorizing rather than focus on the hard facts, which is now explained by the admission that it is time to take a break. In my opinion, the review of the Shaw paper in the British Journal of Cancer on insignifant (?) prostate cancer is overly harsh; all that needed to be said is … we need to read the details in the whole paper before passing judgment. Yes, the progress in diagnosing and treating prostyate cancer is moving in baby steps and that is frustrating. At the same time, new info is coming out that — if catalogued in the right way — can help answer subtle clinical questions.

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