Evaluating the association between radiographic progression free survival and overall survival using the ELMPC4 and ELMPC5 randomized clinical trial data

Lead Investigator: Howard Scher, Memorial Sloan Kettering Cancer Center
Title of Proposal Research: Evaluating the association between radiographic progression free survival and overall survival using the ELMPC4 and ELMPC5 randomized clinical trial data
Vivli Data Request: 9743
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

We plan to study circulating tumor cells (CTCs), cancer cells which have separated from the tumor into the bloodstream potentially leading to the spread of the disease, in patients with prostate cancer. Typically, imaging such as CT scans and MRIs are used to determine whether a patient’s tumor has responded to a given treatment. Our study aims to use data from two studies, ELM-PC4 and ELM-PC5, to develop new criteria to measure response using CTCs, and to directly compare CTC and imaging criteria (RECIST 1.1) to determine whether it is superior and/or complimentary.

No patients/members of the public will be affected directly by this study as all aspects of this analysis will be performed using anonymized data.

Requested Studies:

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
Data Contributor: Takeda
Study ID: NCT01193257
Sponsor ID: C21005

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Data Contributor: Takeda
Study ID: NCT01193244
Sponsor ID: C21004