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

Journal of Clinical Oncology 2014 32:2 (76-82)

Purpose We evaluated angiogenesis-targeted sunitinib therapy in a randomized, double-blind trial of metastatic castration-resistant prostate cancer (mCRPC). Patients and Methods 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…(ver más)

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