Spots Global Cancer Trial Database for Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

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Trial Identification

Brief Title: Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Official Title: A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.

Study ID: NCT01649635

Conditions

Prostate Cancer

Interventions

CABAZITAXEL (XRP6258)

Prednisone

Ciprofloxacin

G-CSF (Granulocyte colony-stimulating factor)

Study Description

Brief Summary: Primary Objective: - To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation. Secondary Objectives: * PSA response rate; * Descriptive assessment of CTC (circulating Tumor Cells); * Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period; * Description of the Health Quality of Life of the patients; * Incidence of adverse events.

Detailed Description: Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months