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Determining the clinical benefit of drug therapies for metastatic castration-resistant prostate cancer (mCRPC) is challenging. Because the disease is highly bone-tropic, it complicates the assessment of treatment response using standard criteria developed for other types of cancer. Also, the use of overall survival (OS) as a regulatory endpoint, which has traditionally been viewed as unambiguous, is compromised by the availability of multiple agents that prolong survival.
To test whether a quantitatively defined radiographic progression-free survival (rPFS) endpoint could serve as a response biomarker in mCRPC, an international group of investigators conducted a follow-up analysis of 1088 chemotherapy-naive mCRPC patients in the COU-AA-302 s…