At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,199 enrolled
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
Enzalutamide 160 mgfrom 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.
Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Enzalutamide and Placebo for Castration-Resistant Prostate Cancer. Completed, enrolled 1,199 participants across 249 sites in 15 countries.
Detailed Summary
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCastration-Resistant Prostate Cancer
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom, United States
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartSep 2009
Primary CompletionSep 2011
Study CompletionNov 2017
TodayJul 2026
First PostedSep 10, 2009
Enrollment StartSep 30, 2009
Primary CompletionSep 15, 2011
Study CompletionNov 2, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 16.8 years ago
Interventions
Enzalutamidedrug
MDV3100, 160 mg orally per day
Placebodrug
Placebo comparator