Spots Global Cancer Trial Database for Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

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Trial Identification

Brief Title: Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

Official Title: Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Study ID: NCT02074137

Conditions

Prostate Cancer Metastatic

Interventions

CABAZITAXEL XRP6258

Prednisone

Prednisolone

Study Description

Brief Summary: Primary Objective: To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer Secondary Objectives: 1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer 2. To describe patient profile in terms of demography, disease characteristics and prior treatment history 3. To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response

Detailed Description: The study consists of: * a screening phase (maximum length of 7-day). * a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent. * a 30-day follow-up visit after the last dose of study medication.