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NCT00255125 · ClinicalTrials.gov registry record · Phase 3
Role of Soy Supplementation in Prostate Cancer Development
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
NCT00255125: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT00255125 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 86 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00255125, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
Study Summary
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.
Primary Outcome
Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.
Interventions
- DRUG Placebo
- DRUG Soy Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00255125 record still lists
NCT00255125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00255125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00255125 about?
NCT00255125 is a clinical study titled "Role of Soy Supplementation in Prostate Cancer Development". This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of the...
What is the current status of trial NCT00255125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2005-09. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00255125?
The interventions under investigation include: Placebo (DRUG), Soy Supplement (DRUG).
Who is sponsoring clinical trial NCT00255125?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00255125's enrollment target sits among peer trials
86 1745th of 2000 higher than 254 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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