ASSESSMENT OF END-POINTS FOR CLINICAL-TRIALS FOR LOCALIZED PROSTATE-CANCER

Objectives. The AUA Practice Guidelines Panel convened to address the issue of appropriate endpoints for assessment of treatment modalities for localized carcinoma of the prostate. Methods. A review of the lite rature and the design of existing clinical trials produced a consensus , which was presented to and critiqued by the members of the general c onference. Results. The pitfalls associated with identification of loc al failure endpoints were discussed, and the more accurate endpoints o f freedom from metastatic progression and overall survival were recogn ized. The strict definition that must be fulfilled for intermediate en dpoints to become surrogates for metastasis free and/or survival endpo ints was stressed. For more efficient and rapid conduct of future clin ical trials, the urgent need to validate such surrogate endpoints by e valuation in randomized control trials is obvious. PSA, while an indic ator of disease activity and a critical marker for estimating disease progression or regression in response to therapy, is not a surrogate f or metastasis free or overall survival. Conclusion. Until surrogate en dpoints are validated, the committee has evaluated the endpoints in cu rrent use, reviewed their limitations, and stressed the importance of quality-of-life assessment together with the traditional endpoint asse ssment. (C) 1997 by Elsevier Science Inc.