Findings From the COU-AA-302 Trial

Howard I. Scher, MD, Chief of the Genitourinary Oncology Service at the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan-Kettering Cancer Center, discusses an updated analysis of the COU-AA-302 trial.

This trial examined treatment with abiraterone acetate (AA) plus prednisone in men with metastatic castration-resistant prostate cancer (mCRPC) prior to the administration of chemotherapy. The trial compared AA plus prednisone to placebo and reported several important findings, Scher suggests.

First, the trial established that a hormonal agent is capable of delaying time to progression and potentially could improve survival. Additionally, the trial helped to establish an important trial design aspect through the validation of radiographic progression-free survival (rPFS) as an endpoint.

Clinical Pearls

This endpoint consisted of a bone scan assay that allowed for consistent interpretation of bone scans. In the trial, a correlation between rPFS and overall survival was observed. This endpoint will serve as a useful tool in future trials, Scher notes, especially for comparing agents and regulatory approval.

• The COU-AA-302 trial compared abiraterone acetate plus prednisone to placebo and reported several important findings
• The trial established that a hormonal agent is capable of delaying time to progression and potentially could improve survival
• The trial helped to establish an important trial design aspect through the validation of rPFS as an endpoint
• This endpoint will serve as a useful tool in future trials, especially for comparing agents and regulatory approval