Please discuss the trial you presented at this year's AUA annual meeting and its implications for the use of hormonal therapy in early prostate cancer.
The role of androgen deprivation therapy in early-stage prostate cancer remains controversial. Questions must be answered about who should receive it and at what doses, and a large, randomized, multicenter trial set out to do just that. The results provide some answers, while raising additional questions. In this interview, Robert C. Flanigan, MD, professor and chairman, department of urology, Loyola University, Maywood, Il, sat down with William A. See, MD, professor and chairman, department of urology, Medical College of Wisconsin, Milwaukee, to discuss the findings and clinical implications of the North American arm of the study, on which Dr. See and colleagues reported at this year's AUA annual meeting in San Antonio.
Q. Please discuss the trial you presented at this year's AUA annual meeting and its implications for the use of hormonal therapy in early prostate cancer.
We have learned many things from this trial. When it was designed, many of the investigators assumed that the patient population across trial centers would be relatively homogeneous. In fact, there was a wide variation in disease stage among the different countries and some practice differences among regions.
Looking at this patient population in retrospect, these patients not only had earlier-stage prostate cancer than those in the European trials, but also, in many respects, they had prostate cancer with an excellent prognosis. These were patients at the "good end" of the risk continuum as evidenced by their pretreatment PSA levels. This has translated into a very low event rate in the control arm, making it very difficult to ascertain the impact of bicalutamide in the experimental arm.
Patients in the European and Scandinavian trials were different from the North American trial, and the data have been illuminating. Patients in those centers had more advanced disease. There was minimal disease burden in the North American patients, intermediate disease in the general European patients, and more advanced disease in the Scandinavian population.