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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Pharmaceutical form:Solution Route of administration: Intravenous
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Tablet Route of administration: Oral
Investigational Site Number 356005
Kollkata, India
Investigational Site Number 356003
New Delhi, India
Investigational Site Number 356002
Trivandrum, India
Number of patients with Related Serious Adverse Events
Time frame: up to13 months
Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications
Time frame: up to 13 months
Radiological overall response (if radiological tumor assessment done) using Recist criteria
Time frame: up to 13 months
Number of patients with at least 50% decrease in PSA
Time frame: up to 13 months
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