At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Asian Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral Enzalutamide in Chemotherapy Naïve Subjects With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
In Brief
A Phase 3 clinical trial evaluating Enzalutamide and Placebo for Progressive Metastatic Prostate Cancer. Completed, enrolled 395 participants across 47 sites in 4 countries.
Detailed Summary
Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProgressive Metastatic Prostate Cancer
CountriesChina, Hong Kong, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedNov 2014
Primary CompletionSep 2015
Study CompletionJul 2024
TodayJul 2026
First PostedNov 19, 2014
Enrollment StartApr 23, 2014
Primary CompletionSep 20, 2015
Study CompletionJul 17, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.6 years ago
Interventions
Enzalutamidedrug
Oral
Placebodrug
Oral