European Organization for Research and Treatment of Cancer (EORTC) prostate cancer trials, 1976-1996

The Genito-Urinary Tract Cancer Cooperative Group (GU Group) is one of the 18 European Organization for Research and Treatment of Cancer (EORTC) cooperative groups. It was established as a nonprofit organization in 1976 with the aim of conducting phase II and phase III clinical trials. Its membership includes urologists, oncologists, radiotherapists, and endocrinologists that work in close collaboration with its five data managers and one statistician in the EORTC Data Center. Eight subcommittees meet independently to plan and to monitor urological trials and to design programs on quality of life and quality control. In the past 20 years, 3,500 prostate cancer patients have been recruited in 16 phase III trials in untreated and advanced disease and in seven phase II trials in hormone-refractory, metastatic disease. This vast experience led the EORTC GU Group to be involved in the development of response and progression criteria, as well as the validation of prognostic factors, quality of life questionnaires, and basic expertise on the design and analysis of prostate cancer trials, including the meta-analysis of the trials with maximal androgen blockade. The conclusions drawn out of this large pool of experience show the complexity of the clinical research questions. Global collaboration and megatrials with the development of surrogate endpoints and the emphasis on quality of life may prove to be as important as the sacred overall survival endpoint. (C) 1998, Elsevier Science Inc. All rights reserved.