According to a media release issued yesterday by the University of North Carolina Lineberger Cancer Center, researchers at this institution have been awarded the first contract we are aware of “to conduct comparative effectiveness research comparing different management strategies for localized prostate cancer.”
The fact that the range of treatments that may be suggested as an appropriate therapy for the management of localized prostate cancer is confusing is well known. The fact that invasive treatment may not even be necessary is less well known. The relative merits of the different forms of treatment — compared to each other and compared to so-called active surveillance (monitoring without invasive therapy) — in carefully defined groups of patients are almost completely unknown.
A research team led by Paul Godley, MD, PhD and Ronald Chen, MD, MPH has now received a contract from the Agency for Healthcare Research and Quality (AHRQ) to “fill gaps in evidence” about which forms of treatment are most effective. Dr. Chen was kind enough to talk with us about this project earlier today.
The plan is to use data available in North Carolina to identify and offer to enroll up to 1,200 patients who have been newly diagnosed with any stage of prostate cancer that is localized to the prostate and the seminal vesicles (i.e., AJCC stages I- III or clinical stages T1-3N0M0). Participation in the study will be entirely voluntary. Once enrolled, patients will be categorized by age, ethnicity, socioeconomic status, and disease risk. They will be asked to complete a range of questionnaires over time, and they will permit the research team to have access to their medical records so that patient perceptions can be cross-checked against the actual records. The initial contract provides funding to follow patients for up to 3 years, but Dr. Chen and his colleagues are clear that they want to be able to follow these patients for as long as possible, and they are already planning to identify follow-up funding over time.
In the first component of the study, the goal is to assess patients’ health-related quality of life (HRQoL) and correlate that to the form of therapy (or monitoring) that they receive. The study will specifically assess things like patients’ urinary, sexual, and bowel function over time regardless of treatment type. In other words, the study is not primarily intended to determine which form of treatment has the “best” oncologic outcome. Rather, it is intended to assess the impact of each treatment on the patient’s overall quality of life over time (although oncologic outcome data will inevitably be an element of all the data collected).
In a second component of the study, the research team will specifically examine outcomes in African American patients and in patients living in medically underserved areas to see whether (and how) differences in patient demographics affect their treatment selection and outcomes. There are several areas of North Carolina that meet federal criteria for being medically underserved, and the research team is particularly interested in being able to assess how access to care affects patient decision processes and subsequent outcomes.
Effectively, this study appears to be potential pilot for the development of a national prostate cancer registry, which The “New” Prostate Cancer InfoLink has called for on a number of occasions as a means to investigate the relative merits of different forms of therapy over time. The Lineberger team recognizes that there are limits to their study in that there will be significant variation in the data collected and available on each individual patient. However, this study may, in itself, allow us to learn a great deal more about the management of prostate cancer outside major medical centers. Currently only two other patient databases offer large-scale information on the management of prostate cancer in the community setting: the CaPSURE database coordinated through the University of California at San Francisco and the SEARCH database, which is derived from data collected at a number of Veterans Administration hospitals.
Whether this study will meet objective criteria for prospective evaluation of the “comparative effectiveness” of differing forms of therapy for prostate cancer is important. Failure to meet such objective criteria is likely to mean that no one takes the results of the study seriously. However, The “New” Prostate Cancer InfoLink is of the opinion that the research team has a sound basic structure to their project. The hard part will be convincing a wide enough variety of patients to participate fully in the study over time. If the research team enrolls 1,200 patients but most of them drop out after a couple of years, then a lot of work will produce data of very limited utility.