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NCT01995513 · ClinicalTrials.gov registry record · Phase 4
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 509
- Enrollment target
NCT01995513: Completed Phase 4 study, sponsored by Pfizer.
NCT01995513 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 509 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01995513, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 509 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Primary Outcome
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new a
Interventions
- DRUG Prednisone
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG Placebo for Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 509 participants |
| Start Date | 2013-10-22 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 4 |
What the finished NCT01995513 record still lists
NCT01995513 is an interventional study that assigns participants to a tested intervention. The registered 509 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT01995513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01995513 about?
NCT01995513 is a clinical study titled "Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients". The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
What is the current status of trial NCT01995513?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 509 participants. The study started on 2013-10-22. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT01995513?
The interventions under investigation include: Prednisone (DRUG), Enzalutamide (DRUG), Abiraterone (DRUG), Placebo for Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT01995513?
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 NCT01995513's enrollment target sits among peer trials
509 162nd of 2000 higher than 1,839 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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