Phase II Trial to Evaluate Benefit of Early Switch from first-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the opposite sequence, exploring molecular markers and mechanisms of taxane resistance in men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy
ID Number 13-1542Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
This study will evaluate the investigational use of cabazitaxel (Jevtana®). An investigational drug is not approved by the United States Food and Drug Administration (FDA) for use except in research studies. Cabazitaxel was approved by the FDA in 2010 for the treatment of metastatic castration resistant prostate cancer previously treated with docetaxel. The FDA approved cabazitaxel to be given at a dose of 25 mg/m² in combination with prednisone. For the purpose of this study, cabazitaxel is considered investigational because it is not approved for treatment of metastatic castration resistant prostate cancer not previously treated with chemotherapy. Prednisone is an FDA-approved steroid for use in the treatment of prostate cancer. Docetaxel is an FDA-approved chemotherapy treatment for several types of cancer, including prostate cancer.
Recruiting Patients: No