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NCT00487721 · ClinicalTrials.gov registry record · Phase 2
The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00487721 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 12 participants.
The verdict
NCT00487721, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Silibinin has demonstrated anti-cancer activity in the laboratory for several different cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle. Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer patients to determine the safety of high-dose treatment. This study is for men with prostate cancer who are planning to have their prostate surgically removed. Participants will be given Silybin-Phytosome three times a day from enrollment in the study until the time of their surgery. Participation in this study will not affect the timing of surgery. We obtain blood and urine samples at the start and completion of the trial in addition to prostate tissue from the surgery. These samples will be analyzed for the effect of Silybin-Phytosome at the end of the study.
Interventions
- DRUG Silibin-Phytosome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00487721
The ClinicalTrials.gov registry entry for NCT00487721 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Silibin-Phytosome is the first listed.
NCT00487721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00487721 about?
NCT00487721 is a clinical study titled "The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer". Silibinin has demonstrated anti-cancer activity in the laboratory for several different cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle. Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer patients to determine the ...
What is the current status of trial NCT00487721?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2006-08. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00487721?
The interventions under investigation include: Silibin-Phytosome (DRUG).
Who is sponsoring clinical trial NCT00487721?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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