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

September 19, 2013 updated by: University of Illinois at Chicago

Randomized Placebo-Controlled Adjuvant Study of Prevention of Prostate Cancer Recurrence After Radical Prostatectomy by Soy Protein Isolate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

284

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer

    • Clinically localized (T1c or T2) disease

  • At high risk for recurrence, as defined by ≥ 1 of the following:

    • Preoperative PSA > 20.0 ng/mL
    • Seminal vesicle invasion
    • Extracapsular extension (excluding the bladder neck)
    • Positive surgical margins (excluding apical margins)
    • Micrometastases in any removed pelvic lymph nodes
    • Final Gleason score of ≥ 8
  • Must have undergone radical prostatectomy for prostate cancer within the past 4 months
  • Must have an undetectable PSA (< 0.07 ng/mL) at baseline, as measured by Tosoh PSA assay
  • No clinical evidence of locally recurrent or metastatic disease

PATIENT CHARACTERISTICS:

  • No significant intake of soy (i.e., more than once a week) at baseline including, but not limited to, any of the following:

    • Vegetarians who regularly consume soy products (e.g., tofu)
    • Individuals with customary Asian dietary habits, including regular intake of soy products
    • Individuals who use soy-based milk replacements
  • No anemia, iron deficiency problems, or subclinical iron deficiency at baseline
  • No diabetes
  • No thyroid disease
  • No requirement for a sodium-free diet
  • No substantive tendency to be constipated (i.e., ≥ grade 2 constipation experienced regularly)
  • No medical problem that would preclude the consumption of the soy containing beverage powder, including allergies against soy (or milk protein)
  • No concurrent major disease, including major mental disease or major substance abuse problems
  • No significant side effects from medication

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent radiotherapy or hormonal therapy
  • No other concurrent adjuvant therapy for prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive an oral soy protein isolate beverage once daily.
Dietary supplement: soy protein isolate
Given orally
Placebo Comparator: Arm II
Patients receive an oral casein placebo beverage once daily.
Other: placebo
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Two-year PSA failure rate (as surrogate for recurrence)
Time to PSA failure

Secondary Outcome Measures

Outcome Measure
Isoflavone uptake or compliance as measured by serum isoflavone concentration
Serum total cholesterol levels
Steroid hormone axis as measured by serum testosterone, estradiol, and SHBG levels
Thyroid activity as measured by serum T3 and T4 levels
Apoptotic activity as measured by serum soluble Fas and Fas-ligand levels
Angiogenesis as measured by serum VEGF and bFGF levels
Oxidative stress as measured by serum 8-isoprostane levels
IGF axis as measured by serum IGF-1 and IGFBP-3 levels
Equol production as measured by serum equol concentration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Maarten C. Bosland, DVSc, PhD, University of Illinois at Chicago
  • Roohollah Sharifi, MD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000615902
  • UIC-2006-0706

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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