Dr. Hussain on Meaningful Effect as an End Point in Prostate Cancer Trials

Maha Hussain, MD, FACP, FASCO, Genevieve E. Teuton Professor of Medicine in the Division of Hematology and Oncology of the Department of Medicine, and the deputy director of the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, discusses the importance of meaningful effect in prostate cancer trials.

Effective treatments are important and metrics to judge effectiveness cannot be limited to a lab value, says Hussain. Achieving a meaningful effect entails delaying the time to cancer spread, enhancing the response rate, and prolonging life, which Hussain emphasizes is the ultimate goal. Using what was discovered in the phase 3 PROSPER study, this is something that has been shown in advanced cancer and has been applied to nonmetastatic castration-resistant prostate cancer. The results provide a good indication of the potential benefit presented to an individual patient. This will hopefully help with guiding therapy for the patient, as well as disease management in terms of imaging and other interventions, Hussain says.

From a research perspective, these types of intermediate end points are important, Hussain explains. To do a large study and empower it for overall survival or metastasis-free survival is expensive, comprises thousands of patients, and can take many years. If multiple ideas are being developed in this setting, such as combination treatments or developing a new agent, looking at meaningful effect as an intermediate end point and an early metric will help to determine whether the treatment is effective. At the end of the day, definitive trials must be done; however, this allows for a shortcut to pick the right therapy, concludes Hussain.