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Dr. Shore on Current Clinical Trial Challenges in CRPC

Panelists: Raoul S. Concepcion, MD, Urology Associates, PC; Steve Dobbs, Urologic Associates of Oklahoma; Bryan A. Mehlhaff, MD, Oregon Urology Institute;
Published: Monday, Feb 18, 2013
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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.
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For High-Definition, Click
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.
View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Personalized Sequencing in Castration-Resistant Prostate Cancer: Bridging the Latest Evidence to the Bedside in Clinical ManagementAug 25, 20181.5
Community Practice Connections™: Precision Medicine for Community Oncologists: Assessing the Role of Tumor-Testing Technologies in Cancer CareNov 30, 20181.0
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