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IGF-1

Insulin-like Growth Factor 1, Somatomedin C

Quick Stats
Studies 92
Trials 100
Completed PHASE2, PHASE3 INTERVENTIONAL NCT00765479

Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

RATIONALE: Soy protein may help prevent prostate cancer recurrence in patients who have undergone surgery for prostate cancer. PURPOSE: This randomized phase II/III trial is studying how well soy protein works and compares it to a placebo in preventing recurrent cancer in patients who have undergone surgery for stage II prostate cancer.

Detailed Description

OBJECTIVES: * Determine whether soy protein isolate reduces the PSA failure rate and time to PSA failure within 2 years following radical prostatectomy in patients who are at high risk for prostate cancer recurrence. * Determine the effects of soy protein isolate on intermediate biomarkers of steroid hormone axis (testosterone, estradiol, and SHBG) and thyroid activity (T3 and T4). * Determine the effects of soy protein isolate on intermediate biomarkers of apoptosis (soluble Fas and Fas-ligand), angiogenesis (VEGF and bFGF), antioxidant activity (8-isoprostanes), and IGF axis (IGF-1 and IGFBP-3). * Compare patients who are equol producers to those who are non-producers. OUTLINE: This is a multicenter study. Patients are stratified according to hospital/clinic site (NYU vs UIC or Jesse Brown VA Medical Center vs other sites), number of high-risk characteristics (1 vs \> 1), and race (African American vs non-African American \[i.e., non-Hispanic White, Hispanic, Asian, and other\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive an oral soy protein isolate beverage once daily. * Arm II: Patients receive an oral casein placebo beverage once daily. Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for biomarker laboratory studies. Samples are analyzed to measure PSA levels by Tosoh PSA assay; cholesterol levels; isoflavone and equol concentrations by HPLC and ESA; and indicators of steroid hormone axis (testosterone, estradiol, and SHBG), indicators of thyroid activity (T3 and T4), indicators of apoptosis (soluble Fas and Fas-ligand), indicators of angiogenesis (VEGF and bFGF), indicators of oxidative stress (8-isoprostanes), and indicators of IGF axis (IGF-1 and IGFBP-3) by ELISA.

Interventions

Name: soy protein isolate
Type: DIETARY_SUPPLEMENT
Description: Given orally
Name: placebo
Type: OTHER
Description: Given orally

Primary Outcomes

Measure: Two-year PSA failure rate (as surrogate for recurrence)
TimeFrame:
Description:
Measure: Time to PSA failure
TimeFrame:
Description:

Trial Information

NCT ID

NCT00765479

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2, PHASE3

Sponsor

University of Illinois at Chicago

Last Updated

December 15, 2025