NCT00345813

Brief Summary

RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery. PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

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

October 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

June 28, 2006

Last Update Submit

August 8, 2018

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation of pretreatment ER-β expression with response to soy supplementation

    after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.

    within 21 days after completetion of supplement regimen

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.

Dietary Supplement: soy isoflavonesDietary Supplement: soy protein isolate

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.

Other: placebo

Interventions

soy isoflavonesDIETARY_SUPPLEMENT

Given orally

Arm I
soy protein isolateDIETARY_SUPPLEMENT

Given orally

Arm I
placeboOTHER

Given orally

Arm II

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Clinically localized disease * Scheduled for radical prostatectomy * No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * No evidence of active nephrolithiasis * No history of hypercalcemic syndrome PRIOR CONCURRENT THERAPY: * No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs * No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil

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

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

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

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Soybean 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

  • M. Craig Hall, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

October 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)