Spots Global Cancer Trial Database for Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer
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Trial Identification
Brief Title: Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer
Official Title: Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.
Study ID: NCT01576029
Conditions
Study Description
Brief Summary: 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
Detailed Description: Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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