Effective Management of Prostate Cancer - Episode 17
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Neal D. Shore, MD, explains that historically, new therapeutics to treat advanced prostate cancer have been approved based on overall survival, except denosumab and zoledronic acid that were approved based on a delay in skeletal-related events. Specifically, he notes, sipuleucel-T, docetaxel, abiraterone, enzalutamide, and cabazitaxel were all approved following phase III trial with overall survival as the primary endpoint.
Consequently, Shore says, researchers are "victims of their own success," since improving overall survival has become more difficult, especially in large trials. Talks have begun, Shore highlights, regarding potential new trial endpoints.
A clear need is present to improve communications with the FDA and European Medical Authority regarding trial designs, Shore says. Conducting clinical trials is very difficult and there has to be consensus on appropriate endpoints.