Is prostate-specific antigen progression a surrogate for objective clinical progression in early prostate cancer?
- 15 July 2004
- journal article
- genitourinary cancer
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 22 (14_suppl) , 4652
- https://doi.org/10.1200/jco.2004.22.14_suppl.4652
Abstract
4652 Background: It is a common misconception that a correlation between endpoints is enough to demonstrate surrogacy. To show true surrogacy, the effect of an intervention on an intermediate endpoint relative to a control treatment needs to reliably predict the effect of the intervention on the clinical outcome of interest. Valid surrogate endpoints are needed to accelerate availability of information about new therapies for early prostate cancer where clinical progression and survival times are prolonged. The usefulness of prostate-specific antigen (PSA) progression as a surrogate for objective clinical progression has therefore been assessed in the bicalutamide (‘Casodex’) Early Prostate Cancer (EPC) Program, the world's largest prostate cancer treatment program. Methods: Individual data from all 8113 patients across 21 countries in the EPC Program were examined. Time to PSA progression and time to objective clinical progression were the endpoints evaluated. The effect of treatment on time to PSA progr...Keywords
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