The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Osaka City University Graduate School of Medicine
Osaka, Japan
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
Time frame: Month 3
Percentage of participants whose PSA decreased 50 percent or more at month 6
Time frame: Month 6
Percentage of participants who showed disease progression at month 3
Time frame: Month 3
Percentage of participants who showed disease progression at month 6
Time frame: Month 6
PSA progression-free survival (PFS)
Time frame: Up to 39 months
QOL measured by functional assessment of cancer therapy-prostate (FACT-P)
Time frame: Up to 39 months
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