Prostate cancer trial is unblinded early
Bayer announced that an Independent Data Monitoring Committee (IDMC) has recommended to unblind the trial due to the observation of an imbalance of more fractures and deaths in the treatment arm investigating radium-223 in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).
Bayer is unblinding the study per the IDMC’s recommendation and will thoroughly analyze the findings and continue monitoring as per study protocol. Data from other types of studies in which this combination treatment was evaluated did not show new safety signals.
Learning Zones
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