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NCT00450749 · ClinicalTrials.gov registry record · Phase 2

Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
10
Enrollment target

NCT00450749: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00450749 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00450749, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well different doses of lycopene work in treating patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from growing or coming back after surgery.

Primary Outcome

Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER placebo
  • PROCEDURE therapeutic conventional surgery
  • DRUG lycopene

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2008-02
Est. Completion 2010-05
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00450749 record still lists

NCT00450749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT00450749 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00450749 about?

NCT00450749 is a clinical study titled "Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer". This randomized phase II trial studies how well different doses of lycopene work in treating patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from growing or coming back after surgery.

What is the current status of trial NCT00450749?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2008-02. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00450749?

The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), therapeutic conventional surgery (PROCEDURE), lycopene (DRUG).

Who is sponsoring clinical trial NCT00450749?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00450749's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00450749, the US trial registry maintained by the National Library of Medicine. NCT00450749 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.