NCT02918968

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

A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in Castration-resistant Prostate Cancer (CRPC) Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus Androgen Deprivation Therapy (ADT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Oral Capsule
DRUG	Flutamide	Oral tablet
OTHER	Androgen deprivation therapy	All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.

Timeline

• Start date: 2016-11-02
• Primary completion: 2020-03-27
• Completion: 2020-03-27
• First posted: 2016-09-29
• Last updated: 2024-12-09
• Results posted: 2021-05-21

Locations

47 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study