CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 86 enrolled
Drug / intervention
Soy Supplement +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00255125
NCT00255125Phase 3Completed

Role of Soy Isoflavones in Prostate Cancer Prevention

VA Office of Research and Development·interventional·Posted Nov 17, 2005·Updated Jun 18, 2019

In Brief

A Phase 3 clinical trial evaluating Soy Supplement and Placebo for Prostate Neoplasm. Completed, enrolled 86 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2005
Enrollment StartSep 1, 2005
Primary CompletionApr 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.6 years ago

Interventions

Soy Supplementdrug

Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Placebodrug

Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).