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Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer.

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Michaelson M.D., Oudard S., Ou Y.C., Sengeløv L., Saad F., Houede N., Ostler P., Stenzl A., Daugaard G., Jones R., Laestadius F., Ullèn A., Bahl A., Castellano D., Gschwend J., Maurina T., Chow Maneval E., Wang S.L., Lechuga M.J., Paolini J., Chen I.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2014 32:2 (76-82)

We evaluated angiogenesis-targeted sunitinib therapy in a randomized, double-blind trial of metastatic castration-resistant prostate cancer (mCRPC). Men with progressive mCRPC after docetaxel-based chemotherapy were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo. Patients also received oral prednisone 5 mg twice daily. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS). Two interim analyses were planned. Overall, 873 patients were randomly assigned to receive sunitinib (n = 584) or placebo (n = 289). The independent data monitoring committee stopped the study for futility after the second interim analysis… (ver más)

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