The Use of Nomogram Predictions as Comparators for Adjuvant Treatment Studies in Prostate Cancer

• Activity Number: 668
• Type: Contributed
• Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biometrics Section
• Author(s): Zhenyu Jia*+ and James Koziol and Michael Lilly and Dan Mercola
• Companies: University of California, Irvine and The Scripps Research Institute and University of California, Irvine and University of California, Irvine
• Keywords: clinical trials ; prostate cancer ; adjuvant multimodality therapy ; Bernoulli ; probability generating functions

Abstract

Nomograms are widely used for predicting clinical outcomes in prostate cancer patients based on relevant clinical characteristics. Here we demonstrate the use of nomogram predictions as comparators to evaluate the efficacy of adjuvant multimodality therapy in patients at high risk for prostate cancer recurrence after radical prostatectomy. Particularly, we describe individual outcomes as independent Bernoulli random variables, with probabilities of failure given from the nomogram. Hence, the total number of observed treatment failures will follow a null distribution which is a convolution of independent, non-identically distributed random variables. This distribution can be easily computed using probability generating functions which facilitates statistical test for phase II trials of small sample sizes.