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NCT00809458 · ClinicalTrials.gov registry record · Phase 3
Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer
A Phase 3 study, sponsored by New Mexico Cancer Research Alliance.
- Terminated
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT00809458: Clinical Trial Phase 3 study, sponsored by New Mexico Cancer Research Alliance.
NCT00809458 is a Phase 3 study that was terminated before completion, run by New Mexico Cancer Research Alliance. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00809458, a Phase 3 study, was terminated before completion, sponsored by New Mexico Cancer Research Alliance.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the tumor cells may die. Vitamin E is a commonly used vitamin that has not been approved by the Food and Drug Administration for use in this type of cancer or for any known cancer. This study will test the hypothesis that vitamin E, in the setting of an oxidative stress such as smoking, can reduce prostate cancer related biomarkers in patients with localized prostate cancer in the neoadjuvant setting.
Primary Outcome
PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.
Interventions
- DRUG Vitamin E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
Why NCT00809458 stopped before completion
NCT00809458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin E is the first listed.
NCT00809458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00809458 about?
NCT00809458 is a clinical study titled "Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer". The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the tumor cells may die. Vitamin E is a commonly used vitamin that has not been approved by the Food and Drug Administrat...
What is the current status of trial NCT00809458?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2008-09. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00809458?
The interventions under investigation include: Vitamin E (DRUG).
Who is sponsoring clinical trial NCT00809458?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00809458's enrollment target sits among peer trials
15 1977th of 2000 higher than 18 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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