At a glance
ClinicalIndex Comparison RecordPhase 2Active· 100 target
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.
NCT04015622Phase 2ActiveMonitorUpdated 10mo ago · Completion was 3mo agoSlow Enrollment
A Randomized Phase II Trial Comparing Biomarker Directed Therapy Versus Clinician's Choice of Enzalutamide or Docetaxel in Patients With Advanced Prostate Cancer Post Abiraterone
In Brief
A Phase 2 clinical trial evaluating Enzalutamide and Docetaxel for Metastatic Castration-Resistant Prostate Cancer (mCRPC). Active but no longer recruiting, targeting 100 participants across 7 sites.
Signals
Enrolling slower than its timeline implies
Detailed Summary
The purpose of this study is to assess the strategy in treatment selection using ctDNA fraction as a predictive biomarker to direct treatment decision (ctDNA fraction \<2% receives enzalutamide, and ctDNA fraction ≥2% receives docetaxel) versus clinician's choice of enzalutamide or docetaxel, in subjects with metastatic castration-resistant prostate cancer post abiraterone setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--
Timeline
Phase 2Active
20202021202220232024202520262027
First PostedJul 2019
Enrollment StartOct 2020
Primary CompletionApr 2026
TodayJul 2026
Study CompletionDec 2026
First PostedJul 11, 2019
Enrollment StartOct 7, 2020
Primary CompletionApr 1, 2026
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 7.0 years ago
Interventions
Enzalutamidedrug
Enzalutamide 160 mg PO OD
Docetaxeldrug
Docetaxel 75 mg/m2 IV every 3 weeks