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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00031746
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: soy protein isolate Dietary Supplement: casein proteins Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
Study Start Date : February 2000
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Casein
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: soy protein + isoflavones Dietary Supplement: soy protein isolate
25 mg daily
Active Comparator: casein proteins Dietary Supplement: casein proteins
25 mg daily


Outcome Measures

Primary Outcome Measures :
  1. Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67 [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031746


Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: James L. Mohler, MD Roswell Park Cancer Institute
More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00031746     History of Changes
Other Study ID Numbers: CALGB-79806
U10CA076001 ( U.S. NIH Grant/Contract )
NCI-P02-0207
CDR0000069221 ( Registry Identifier: NCI Physicians Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action