drugset / Trial / NCT02918968

Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

NCT02918968

Phase 4 Completed 206 enrolled Astellas Pharma Inc Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).

Timeline

Start
2016-11-02
Primary completion
2020-03-27
Completion
2020-03-27

Drugs

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

Indications