The PCCTC imaging data capture toolset: An analysis of its impact on prostate cancer clinical trial accuracy and workload.

Abstract

4635 Background: Prostate Cancer Working Group 2 (PCWG2) Concensus Criteria proposed time-to-event endpoints in early-phase clinical trials. Chief among these was time to radiographic progression for bone scintigraphy, based on a standardized definition with additional specifications to distinguish early “flare” from true progression. The Prostate Cancer Clinical Consortium (PCCTC) created a bone scan data capture tool to standardize and operationalize these definitions in clinical trials. We tested the hypothesis that the tool would improve clinical trial workload and data accuracy. Methods: At Memorial Sloan-Kettering Cancer Center (MSKCC), the PCCTC bone scan tool was vetted through 9 versions over the course of 3 years. Reproducibility, ease-of-use and accuracy were tested over the course of 12 clinical trials. To assess workload, accruals at MSKCC of two phase III trials using the same drug, contracting research organization (CRO) and electronic data capture system were analyzed. The first trial did not use the PCCTC tool and the second incorporated it in its data collection plan and case report form. Workload and data capture adequacy for each trial were determined by examining the number of imaging queries from the CRO as a function of the number of scans and patients. Results: Data from this analysis are found in the table below. The relative number of queries per scan was reduced by 86.71% by use of the tool. The queries:scan ratios were 0.82 versus 0.11 before and after the use of the tool respectively; likewise, the ratios of queries:patient were 2.81 vs. 0.56. Conclusions: Using the PCCTC bone scan data capture tool, data are more completely reported and workload is decreased. The reproducibility and feasibility of the tool is further being tested in phase III studies in which PCWG2 criteria are being clinically qualified. These efforts to quantitate, standardize and qualify imaging data advance the goal of developing an imaging biomarker in metastatic prostate cancer. Support: DOD PC071610. 2008 phase III 2009 phase III without tool with tool Patients 16 41 Queries 45 23 Scans 55 211 Avg queries/patient 2.81 0.56 Avg scans/patient 3.44 5.15 Queries/scan 0.82 0.11 Reduction in queries/scan with tool -86.71%