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Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval

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University of North Carolina at Chapel Hill Chapel Hill United States

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The objective of this work is to establish standard methods for measuring pain palliation and pain progression in prostate cancer clinical trials that are feasible, methodologically rigorous, and meet regulatory requirements for drug approval and labeling. The primary aim of this award is to conduct an observational longitudinal study in men with castrate-resistant metastatic prostate cancer receiving docetaxel-based chemotherapy, in order to establish key design elements of a pain endpoint model which can be used in pivotal trials. SUMMARY We report the following progress 1 the study designed to address Aim 1 is accruing patients at all four sites 2 a manuscript resulting from the work described in Aim 2 has been published in the journal European Urology, titled Effects of Cabozantinib on Pain and Narcotic Use in Patients with Castration-resistant Prostate Cancer Results from a Phase 2 Nonrandomized Expansion Cohort and 3 the manuscript resulting from work described in Aim 3 has been published by the journal Cancer, titled Pain Palliation Measurement in Cancer Clinical Trials The US Food and Drug Administration Perspective. Both manuscripts have been attached to annual report submitted to Department of Defenses in November 2015.

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Technical Report,30 Sep 2014,29 Sep 2015



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Approved For Public Release;

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