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CompletedNCT00031746Updated Jul 19, 2016

Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels

A Phase 2 interventional study of soy protein isolate and casein proteins in Prostate Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 5 sites in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-07-19.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study summary

RATIONALE: Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (PSA) levels.

PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.

Read the detailed description

OBJECTIVES:

  • Compare the reduction in the rate of prostatic cellular proliferation in patients with an elevated PSA (5 to 10 ng/mL) and a negative biopsy for prostate cancer when treated with daily soy protein supplements vs placebo.
  • Compare the effect of these regimens on additional biomarkers of prostate cancer (PSA, high-grade prostate intraepithelial neoplasia, induction of apoptosis, sex steroid receptor expression, and loss of glutathione S-transferase-pi) in these patients.
  • Compare the effect of these regimens on quality of life, including urinary and sexual function, in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to race (Caucasian vs African American). After 2 weeks of daily oral placebo, patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive oral soy protein supplement daily for 12 months.
  • Arm II: Patients receive oral placebo daily for 12 months. Quality of life is assessed at baseline and at 6 and 12 months.

PROJECTED ACCRUAL: A total of 160 patients (80 per arm) will be accrued for this study within 12 months.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 26 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed absence of prostate cancer

    • Atypical adenomatous hyperplasia or prostatic intraepithelial neoplasia (high-grade or low-grade) allowed
    • Abnormal baseline transrectal ultrasound and digital rectal exam allowed
    • Biopsy may be before or after study entry, but must be within the past 90 days
  • PSA 5-10 ng/mL

PATIENT CHARACTERISTICS:

Age:

  • 50 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No known allergy to soy protein or milk protein
  • No invasive cancer within the past 5 years except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No prior hormonal therapy
  • No prior finasteride
  • No concurrent hormonal therapy
  • No concurrent finasteride

Radiotherapy:

  • Not specified

Surgery:

  • At least 6 months since prior transurethral resection of the prostate
  • No prior orchiectomy
  • No concurrent orchiectomy

Other:

  • No other concurrent soy products
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    soy protein + isoflavones

    Dietary Supplement: soy protein isolate

  • Active comparator
    casein proteins

    Dietary Supplement: casein proteins

Interventions

  • Dietary supplementsoy protein isolate

    25 mg daily

  • Dietary supplementcasein proteins

    25 mg daily

06

What researchers measure

Primary outcomes

  1. Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67

    Time frame: 12 months

07

Study locations

5 sites
  • Walter Reed Army Medical Center
    Washington, District of Columbia 20307-5001, United States
  • CCOP - Hematology-Oncology Associates of Central New York
    Syracuse, New York 13057, United States
  • Community General Hospital of Greater Syracuse
    Syracuse, New York 13215, United States
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    Columbus, Ohio 43210-1240, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00031746
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Feb 2000
Primary completion
Jun 2006
Completion
Jun 2006
Last update
Jul 19, 2016

Study contacts

James L. Mohler, MD
study chair · Roswell Park Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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