Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval
Abstract
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 third year, we report the following progress: (1) we anticipate the study designed to address Aim 1 to open at UNC in November/December 2013, and the study will open at the additional sites in Q1 2014; (2) a manuscript resulting from the work described in Aim 2 has been written and approved by all authors and by the industry sponsor. This manuscript is planned for submission to a peer reviewed journal during the next quarter; and (3) the manuscript resulting from work described in Aim 3 was accepted for publication by the journal Cancer and it is currently in the press. The title of the manuscript is: Pain Palliation Measurement in Cancer Clinical Trials: The US Food and Drug Administration Perspective .
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2013
- Accession Number
- ADA594899
Entities
People
- Antonia V Bennett
- Ethan Basch
Organizations
- University of North Carolina at Chapel Hill