Primary Objective: * To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels. Secondary Objectives: * PSA response rate * Overall survival (OS) * Incidence of Adverse Events
Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Pharmaceutical form: solution Route of administration: intravenous
Pharmaceutical form: solution Route of administration: intravenous
Investigational Site Number 004
Barretos, Brazil
Investigational Site Number 008
Brasília, Brazil
Investigational Site Number 009
Londrina, Brazil
Investigational Site Number 003
Mogi das Cruzes, Brazil
Investigational Site Number 005
Porto Alegre, Brazil
Investigational Site Number 006
Rio de Janeiro, Brazil
Investigational Site Number 001
Rio de Janeiro, Brazil
Investigational Site Number 007
São Paulo, Brazil
Median time to PSA progression
Time frame: up to 60 days
PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA
Time frame: up to 60 days
Overall Survival: Median time elapsed between the date of starting treatment until death by any cause
Time frame: up to a maximum of 2 years
Number of patients with adverse events
Time frame: up to a maximum of 2 years
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