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NCT01288911 · ClinicalTrials.gov registry record · Phase 2
A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
A Phase 2 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 375
- Enrollment target
NCT01288911: Completed Phase 2 study, sponsored by Astellas Pharma.
NCT01288911 is a Phase 2 study that has completed, run by Astellas Pharma. The registered enrollment target is 375 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (182% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01288911, a Phase 2 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 375 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.
Primary Outcome
PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response
Interventions
- DRUG enzalutamide
- DRUG bicalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2011-03-22 |
| Est. Completion | 2017-11-08 |
| Phase | Phase 2 |
What the finished NCT01288911 record still lists
NCT01288911 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (182% higher).
The record links to 0 conditions, and to 2 interventions - of which enzalutamide is the first listed.
NCT01288911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01288911 about?
NCT01288911 is a clinical study titled "A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer". The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.
What is the current status of trial NCT01288911?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 375 participants. The study started on 2011-03-22. Estimated completion is 2017-11-08.
What interventions are being tested in trial NCT01288911?
The interventions under investigation include: enzalutamide (DRUG), bicalutamide (DRUG).
Who is sponsoring clinical trial NCT01288911?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01288911's enrollment target sits among peer trials
375 116th of 2000 higher than 1,883 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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