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.
Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Pharmaceutical form: solution Route of administration: intravenous
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: solution Route of administration: subcutaneous
Investigational Site Number 007
Centro, Brazil
Investigational Site Number 004
Curitiba, Brazil
Investigational Site Number 006
Lajeado, Brazil
Investigational Site Number 005
Porto Alegre, Brazil
Investigational Site Number 001
Santo André, Brazil
Investigational Site Number 002
São Paulo, Brazil
Proportion of patients with some episode of neutropenia classified as grade ≥ 3
Time frame: 21 days
Proportion of patients with episode of neutropenia grade ≥3
Time frame: up to 24 months (every 21 days)
Rate of febrile neutropenia
Time frame: up to 24 months (every 21 days)
Rate of diarrhea grade ≥3
Time frame: up to 24 months (every 21 days)
PSA response rate
Time frame: up to 24 months (every 21 days)
Circulating Tumor Cells Count (CTC) rate
Time frame: Day 42, Day 84, Day 126 and End of Treatment
Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI)
Time frame: up to 24 months (every 21 days)
Number of patients with adverse events
Time frame: up to 24 months (every 21 days)
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