Assessment of endpoints 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 literature and the design of existing clinical trials produced a consensus, which was presented to and critiqued by the members of the general conference. Results. The pitfalls associated with identification of local failure endpoints were discussed, and the more accurate endpoints of freedom from metastatic progression and overall survival were recognized. The strict definition that must be fulfilled for intermediate endpoints to become surrogates for metastasis free and/or survival endpoints was stressed. For more efficient and rapid conduct of future clinical trials, the urgent need to validate such surrogate endpoints by evaluation in randomized control trials is obvious. PSA, while an indicator of disease activity and a critical marker for estimating disease progression or regression in response to therapy, is not a surrogate for metastasis free or overall survival. Conclusion. Until surrogate endpoints are validated, the committee has evaluated the endpoints in current use, reviewed their limitations, and stressed the importance of quality-of-life assessment together with the traditional endpoint assessment. (C) 1997 by Elsevier Science Inc.