The objective of this proposal is to continue to provide research and laboratory core support to the Cooperative Clinical Trials of the National Cancer Institute's National Prostatic Cancer Project. For purpose of quality control, it is imperative for the various participating centers to have uniform biological markers, relevant to monitoring the efficacy of prostate cancer treatment and management, in various treatment protocols. An objective clinical pathological evaluation can be performed effectively in a cooperative group only from a standard set of tests and data. The evaluation will be carried out from clinical information compiled at the Central Statistics Office of the group, and from multiple laboratory tests, as provided by this proposal, that are not readily available in participating hospitals locally or routinely. Serum prostate-specific antigen, prostatic acid phosphatase, bone isoenzyme and liver isoenzyme of alkaline phosphatase will be measured. Any new biomarkers or assay procedures, which will indicate improved and/or additive clinical value in monitoring the treatment response of prostate cancer, can be added to the panel of tests as they become available. Computer-assisted statistical techniques, e.g. the Cox model and logistic model, among others, will be used for systematic and objective clinical-laboratory analysis. Additionally, establishment and inventory of a serum bank of prostate cancer will be carefully maintained and further expanded. This serum bank represents a national resource. The purpose of this renewal proposal is to continue the core function of this central laboratory, which has been a major component and has played as essential role in the continued success of the major cooperative clinical trial on prostate cancer under the auspices of the National Cancer Institute.
