The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to improve the disease control in first line CRPC patients.
CHEIRON trial is a phase II randomized study comparing docetaxel plus enzalutamide to docetaxel alone as first line for castration resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form : soft gelatin capsules Route of administration: oral
Santa Chiara Hospital
Trento, Italy
Rate of patients without progression (according to guideline of Prostate Cancer Clinical Trials Working Group 2 - PCWG2)
Rate of patients without progression (according to guideline of Prostate Cancer
Time frame: 6 months after docetaxel first administration
Rate of objective response according to RECIST criteria
Rate of objective response according to RECIST criteria
Time frame: 6 months after docetaxel first administration
Rate of biochemical response according to PCWG2
Rate of biochemical response according to PCWG2
Time frame: 6 months after docetaxel first administration
Kaplan-Meier estimates of progression-free survival
Kaplan-Meier estimates of progression-free survival
Time frame: 6 months after docetaxel first administration
Kaplan-Meier estimates of overall survival
Kaplan-Meier estimates of overall survival
Time frame: 6 months after docetaxel first administration
Kaplan-Meier estimates of biochemical progression-free survival
Kaplan-Meier estimates of biochemical progression-free survival
Time frame: 6 months after docetaxel first administration
Rate of treatment-related mortality
Rate of treatment-related mortality
Time frame: 6 months after docetaxel first administration
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Rate of toxicity-related protocol withdrawal
Rate of toxicity-related protocol withdrawal
Time frame: 6 months after docetaxel first administration
Scales of brief pain inventory (BPI)
Scales of brief pain inventory (BPI
Time frame: 6 months after docetaxel first administration
Analgesic score
Analgesic score
Time frame: 6 months after docetaxel first administration
Functional scales and items of FACT - P questionnaire
Functional scales and items of FACT - P questionnaire
Time frame: 6 months after docetaxel first administration
Type and grade of any adverse reaction to treatment, according to CTC-AE v. 4.03
Type and grade of any adverse reaction to treatment, according to CTC-AE v. 4.03
Time frame: 6 months after docetaxel first administration