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Dr. Ryan on the Unblinding of the COU-AA-302 Trial

Charles J. Ryan, MD
Published: Monday, Aug 13, 2012

Charles J. Ryan, MD, medical oncologist, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the unblinding of the COU-AA-302 trial, a phase III study of abiraterone acetate (Zytiga) plus prednisone in chemotherapy-naïve, asymptomatic or mildly symptomatic, patients with metastatic castration-resistant prostate cancer.

The data for the interim analysis was collected in December 2011, compiled, and was reviewed by the Independent Data Monitoring Committee in the middle of February 2012. In aggregate, abiraterone acetate's ability to improve the co-primary endpoints of radiographic progression-free survival, overall survival, and secondary endpoints, such as time to chemotherapy, pain, and the deterioration of performance status, led to the committee's recommendation to unblind the trial.

Ryan believes it is important to note that although the COU-AA-302 trial was unblinded it was not stopped. The trial is currently ongoing and patients are still being monitored. The final analysis of the full data will become available at the completion of the trial.

Charles J. Ryan, MD, medical oncologist, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the unblinding of the COU-AA-302 trial, a phase III study of abiraterone acetate (Zytiga) plus prednisone in chemotherapy-naïve, asymptomatic or mildly symptomatic, patients with metastatic castration-resistant prostate cancer.

The data for the interim analysis was collected in December 2011, compiled, and was reviewed by the Independent Data Monitoring Committee in the middle of February 2012. In aggregate, abiraterone acetate's ability to improve the co-primary endpoints of radiographic progression-free survival, overall survival, and secondary endpoints, such as time to chemotherapy, pain, and the deterioration of performance status, led to the committee's recommendation to unblind the trial.

Ryan believes it is important to note that although the COU-AA-302 trial was unblinded it was not stopped. The trial is currently ongoing and patients are still being monitored. The final analysis of the full data will become available at the completion of the trial.


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