"Drs. Richard Cote and John P. Stein lead a strong GenitoUrinary Oncology Program. The program includes a number of internationally recognized, well-established clinical investigators, strong basic science, and productive collaborations with members of the Epidemiology Program. During the last grant cycle, these investigators initiated important and innovative translational clinical trials in both prostate and bladder cancers using information gleaned from a unique database created by Dr. Don Skinner (Chief of Urology at the Norris Hospital). Dr. Skinner and his colleagues created a clinical database that contains information on more than 1600 bladder cancer patients and approximately 2200 prostate cancer patients. Importantly, the patients contained within these databases were treated in a fairly consistent manner. Furthermore, the clinical data are linked to the patients’ paraffin-embedded tissue specimens. This invaluable and unique data set has allowed the GU investigators to conduct exploratory correlative studies that examine putative molecular prognostic and predictive markers. In concert with their epidemiology colleagues, GU investigators used this unique database to develop molecular profiles of bladder and prostate cancers that were subsequently used to distinguish subsets of patients with unfavorable outcomes following standard therapy. To test the validity of these molecular profiles, a series of investigator-initiated trials have been undertaken. For example the group hypothesized that patients with invasive bladder cancer and p53 abnormalities may be good candidates for adjuvant chemotherapy since they appear to be at higher risk for recurrence. To test this hypothesis, they organized and now lead an ongoing international trial that prospectively employs the molecular profile finding in a stratification factor. Patients with resected bladder cancer and a poor prognostic molecular profile are randomized between treatment and no treatment. This is a superb example of bench to bedside translational research. Because of its excellent leadership, the GU Program is destined to remain one of the premier elements of the Cancer Center in the coming grant cycle.”