drugset / Trial / NCT02918968
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
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
Outcome
Met primary endpoint
registry Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT vs Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT; p <0.001 NCT02918968 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Subject | Flutamide | Small molecule | 125 mg | Oral |