NCT00064194

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in preventing the development of prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combining vitamin E, selenium, and soy protein in preventing prostate cancer in patients who have high-grade prostate neoplasia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2008

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

6.4 years

First QC Date

July 8, 2003

Last Update Submit

April 1, 2020

Conditions

Precancerous/Nonmalignant ConditionProstate Cancer

Keywords

prostate cancerhigh grade prostatic intraepithelial neoplasia

Interventions

seleniumDIETARY_SUPPLEMENT
soy protein isolateDIETARY_SUPPLEMENT
vitamin EDIETARY_SUPPLEMENT

Eligibility Criteria

AgeUp to 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed high-grade prostatic intraepithelial neoplasia (HGPIN) * No evidence of invasive prostate cancer by at least 2 biopsies within the past 18 months * At least 1 biopsy must show evidence of HGPIN within the past 6 months * No prior invasive prostate cancer PATIENT CHARACTERISTICS: Age * Not specified Performance status * Not specified Life expectancy * More than 5 years Hematopoietic * Platelet count at least 75,000/mm\^3 * No coagulopathies Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * PT (INR) no greater than 1.5 times ULN * PTT no greater than 1.5 times ULN * No hepatic insufficiencies Renal * Creatinine no greater than 2 times ULN * No renal insufficiencies Other * No prior nonmelanoma skin cancer (e.g., squamous cell or basal cell carcinoma) * No other malignancy within the past 5 years except superficial bladder cancer * No known bowel malabsorption * No dietary behavior (e.g., morbid obesity or eating disorders) that would limit adherence to study therapy * No major illness, including psychiatric illness, that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 3 months since prior androgen therapy * More than 3 months since prior hormonal therapy for benign prostatic hyperplasia (e.g., finasteride) * No concurrent finasteride * No concurrent androgen therapy Radiotherapy * More than 2 years since prior radiotherapy to the pelvic region Surgery * Not specified Other * More than 2 weeks since prior supplemental vitamin E or selenium * No other concurrent vitamin E (greater than 100 IU/day), selenium, or soy protein isolate (more than 2 servings/week) * No other concurrent treatment for high-grade prostatic intraepithelial neoplasia

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

Sponsors & Collaborators

Study Sites (3)

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Fleshner NE, Kapusta L, Donnelly B, Tanguay S, Chin J, Hersey K, Farley A, Jansz K, Siemens DR, Trpkov K, Lacombe L, Gleave M, Tu D, Parulekar WR. Progression from high-grade prostatic intraepithelial neoplasia to cancer: a randomized trial of combination vitamin-E, soy, and selenium. J Clin Oncol. 2011 Jun 10;29(17):2386-90. doi: 10.1200/JCO.2010.32.0994. Epub 2011 May 2.

    PMID: 21537051RESULT

MeSH Terms

Conditions

Precancerous ConditionsProstatic Neoplasms

Interventions

SeleniumSoybean ProteinsVitamin E

Condition Hierarchy (Ancestors)

NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and BeveragesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Neil Fleshner

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

November 28, 2001

Primary Completion

April 30, 2008

Study Completion

April 30, 2008

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)