Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval
Annual rept. 30 Sep 2011-29 Sep 2012
SLOAN-KETTERING INST FOR CANCER RESEARCH NEW YORK
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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 At the close of the first year, we report the following progress 1 we anticipate the study designed to address Aim 1 to open at UNC and MSKCC in January February 2013, and the study will open at the additional sites in Q2 2013 2 the work outlined for Aim 2 will be conducted, as scheduled, in Months 16-36 and 3 the manuscript resulting from work described in Aim 3 is under review by a major scientific journal.
- Medicine and Medical Research