BACKGROUND: Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 ( METHODS: For patients with metastatic castration-resistant prostate cancer treated with RESULTS: Of 785 patients with baseline and Week 12 ALP measurements, 779 were eligible for the OS analyses. Overall, 80% of patients had an ALP decline. Median OS was longer in patients with than without an ALP decline (18.1 versus 14.2 months
HR 0.74
95% CI 0.60-0.92). In patients with an ALP decline, there was no clear OS difference between those with versus without a pain response. For patients without ALP decline, median OS was longer in those with versus without a pain response (16.2 versus 10.9 months
HR 0.50
95% CI 0.32-0.77). CONCLUSIONS: Decreases in ALP and/or pain during CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02141438. Analyses from the radium-223 REASSURE global study suggest that declines in alkaline phosphatase and pain during treatment may predict longer survival in patients with advanced prostate cancer and may help doctors make decisions with their patients.