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NCT00345813 · ClinicalTrials.gov registry record · Phase 2

Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target

NCT00345813: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.

NCT00345813 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00345813, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target

Study Summary

RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery. PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.

Primary Outcome

after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.

Interventions

  • OTHER placebo
  • DIETARY_SUPPLEMENT soy protein isolate
  • DIETARY_SUPPLEMENT soy isoflavones

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2003-10
Est. Completion 2006-07
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT00345813 record still lists

NCT00345813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00345813 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00345813 about?

NCT00345813 is a clinical study titled "Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer". RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery. PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prosta...

What is the current status of trial NCT00345813?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2003-10. Estimated completion is 2006-07.

What interventions are being tested in trial NCT00345813?

The interventions under investigation include: placebo (OTHER), soy protein isolate (DIETARY_SUPPLEMENT), soy isoflavones (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00345813?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00345813's enrollment target sits among peer trials

62 1016th of 2000 higher than 975 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 NCT00345813, the US trial registry maintained by the National Library of Medicine. NCT00345813 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.