C Parker, S Nilsson, D Heinrich, S I Helle, J M O'Sullivan, S D Fosså, A Chodacki, P Wiechno, J Logue, M Seke, A Widmark, D C Johannessen, P Hoskin, D Bottomley, N D James, A Solberg, I Syndikus, J Kliment, S Wedel, S Boehmer, M Dall'Oglio, L Franzén, R Coleman, N J Vogelzang, C G O'Bryan-Tear, K Staudacher, J Garcia-Vargas, M Shan, Ø S Bruland, O Sartor
BACKGROUND: Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. METHODS: In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks...
July 18, 2013: New England Journal of Medicine