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In Reply: We agree with Dr Sherr that the radiotherapy dose for this protocol, which was designed in 1987, was lower than that which would be used today. Because most studies to date have demonstrated a greater efficacy for a higher dose of radiotherapy, we too might expect a greater difference in outcomes if the study were initiated today. While the effect on metastasis-free survival was close to the criterion for statistical significance, the lower than expected event rate had a major effect on the study's ability to reach statistical significance.

Dr Pisansky and colleagues comment on the study's primary end point. We agree that based on the rates of metastasis seen over the course of the study, the trial was underpowered to assess the primary end point. An enormous and perhaps unachievable study size would have been required to fully address this question. Although the metastasis-free results in which . . . [Full Text of this Article]

Ian M. Thompson, MD
thompsoni@uthscsa.edu
Department of Urology
University of Texas Health Science Center at San Antonio

Catherine M. Tangen, DrPH
Southwest Oncology Group Statistical Center
Seattle, Wash

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