Dr. Morris on rPFS as an Endpoint in Clinical Trials

Michael J. Morris, MD, medical oncologist, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, discusses the use of radiographic progression-free survival (rPFS) as an endpoint in prostate cancer clinical trials.

Traditionally, Morris says, it had to be demonstrated that patients lived longer (overall survival) or better (skeletal-related event prevention) as a result of treatment. These endpoints take substantial time to evaluate. Morris also notes that it is difficult to determine if benefit is a result of the drug being tested or another therapy given after the conclusion of a clinical trial.

The challenge of finding earlier endpoints that are closely associated with overall survival may have been answered by rPFS, which is a standardized definition of when a patient has progressed on a trial. Researchers and physicians are setting the stage for rPFS to be established as an interim endpoint in this disease as it is so closely associated with a "hard" clinical endpoint.