Prostate Cancer Metastatic Clinical Trial
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
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
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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