The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP).

ABSTRACT: New systemic therapies have prolonged the lives of men with metastatic castration-resistant prostate cancer (mCRPC). Use of these therapies in the adjuvant setting when the disease may be micrometastatic and potentially more sensitive to therapies may decrease mortality from prostate cancer. However, the conduct of adjuvant prostate cancer clinical trials is hampered by taking longer than a decade to reach the meaningful endpoint of overall survival (OS) and the fact that many men never die from prostate cancer, even if they relapse. A validated intermediate clinical endpoint (ICE) in prostate cancer that is a robust surrogate for OS has yet to be defined. This paper details the plans, process, and progress of the international Intermediate Clinical Endpoints in Cancer of the Prostate (ICE

SUBMITTER: ICECaP Working Group 

PROVIDER: S-EPMC5964738 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature