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NCT00459407 · ClinicalTrials.gov registry record · Phase 1
Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00459407: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00459407 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00459407, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate
Primary Outcome
Descriptive statistics will be performed on prostate tissue EGCG within each intervention group. The difference in concentration levels between the two intervention groups will be tested using a two-group t-test at a one-sided 0.05 level of significance. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. The percentage of patients positive for EGCG in prostate tissue will be compared between the intervention groups using a Fisher's exact test of proporti
Interventions
- DRUG placebo
- OTHER laboratory biomarker analysis
- OTHER immunohistochemistry staining method
- OTHER immunoenzyme technique
- DIETARY_SUPPLEMENT defined green tea catechin extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-03 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
What the finished NCT00459407 record still lists
NCT00459407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00459407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00459407 about?
NCT00459407 is a clinical study titled "Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate". Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate
What is the current status of trial NCT00459407?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2007-03. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00459407?
The interventions under investigation include: placebo (DRUG), laboratory biomarker analysis (OTHER), immunohistochemistry staining method (OTHER), immunoenzyme technique (OTHER), defined green tea catechin extract (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00459407?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00459407's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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