Objective and Specific Aims The study objective is to quantify the impact of adding the ODX assay to standard, patient-centered counseling in low-intermediate risk PCa with the following specific aims (endpoints): 1. Choice of treatment (primary endpoint). We will test the hypothesis that the ODX assay will increase selection of active surveillance in AA men (and Hispanic men, in exploratory analysis). 2. Perceived risk of a poor outcome (death, disability). We will test the hypothesis that the test will decrease perceived risk among men whose gene profiles indicate a substantial decrease in predicted risk, regardless of treatment choice. We will also quantify the degree of increased risk perception among men whose test shifts the risk level upward. 3. Changes in mood/anxiety during the pretreatment period. We will test the hypothesis that the assay will improve mood and lessen anxiety among men whose risk level is downshifted as a result of the test. We will also quantify the degree of worsened mood and increased anxiety among men whose risk level is adjusted upward. 4. Prediction of adverse pathology. We will test the hypothesis that the prediction accuracy of the pre-specified ODX test differs between AA and Hispanic men and differs in both these groups from published data for white men. We will use the ODX assay to predict upgrading and upstaging on RP pathology, as well as tumor volume and grade progression on AS re-classification biopsy. As an exploratory aim, we will also determine whether re-weighting the ODX algorithm for AA and Hispanic men provides better calibration for these endpoints.
|Effective start/end date
|9/15/15 → 9/14/19
- U.S. Army Medical Research and Materiel Command (W81XWH-15-1-0534)
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