drugset / Trial / NCT02346578

Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.

NCT02346578

Phase 2 Completed 104 enrolled Taro Iguchi, MD, PHD Astellas Pharma Inc · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-12
Primary completion
2018-09-30
Completion
2019-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified 160 mg Oral
Comparator flutamide Small molecule 125 mg Oral