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NCT01664923 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 396
- Enrollment target
NCT01664923: Completed Phase 2 study, sponsored by Pfizer.
NCT01664923 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 396 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (198% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01664923, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 396 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.
Primary Outcome
PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radio
Interventions
- DRUG Enzalutamide
- DRUG Bicalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2012-08 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
What the finished NCT01664923 record still lists
NCT01664923 is an interventional study that assigns participants to a tested intervention. The registered 396 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 (198% higher).
The record links to 0 conditions, and to 2 interventions - of which Enzalutamide is the first listed.
NCT01664923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01664923 about?
NCT01664923 is a clinical study titled "Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer". The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.
What is the current status of trial NCT01664923?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 396 participants. The study started on 2012-08. Estimated completion is 2018-01.
What interventions are being tested in trial NCT01664923?
The interventions under investigation include: Enzalutamide (DRUG), Bicalutamide (DRUG).
Who is sponsoring clinical trial NCT01664923?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01664923's enrollment target sits among peer trials
396 103rd of 2000 higher than 1,898 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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