NCT00031746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2000

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

6.3 years

First QC Date

March 8, 2002

Last Update Submit

July 15, 2016

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

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

    12 months

Study Arms (2)

soy protein + isoflavones

ACTIVE COMPARATOR
Dietary Supplement: soy protein isolate

casein proteins

ACTIVE COMPARATOR
Dietary Supplement: casein proteins

Interventions

soy protein isolateDIETARY_SUPPLEMENT

25 mg daily

soy protein + isoflavones
casein proteinsDIETARY_SUPPLEMENT

25 mg daily

casein proteins

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, 13057, United States

Location

Community General Hospital of Greater Syracuse

Syracuse, New York, 13215, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Soybean Proteinsalpha-casein-binding proteins

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • James L. Mohler, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

February 1, 2000

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

US(5)