Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Comprehensive Cancer Center of Wake Forest University

ClinicalTrials.gov Identifier:

NCT00345813

First received: June 28, 2006

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2006

Last Updated Date

June 28, 2012

Start Date ^ICMJE

October 2003

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation of pretreatment ER-β expression with response to soy supplementation [ Time Frame: within 21 days after completetion of supplement regimen ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00345813 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

Official Title ^ICMJE

Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression

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.

Detailed Description

OBJECTIVES:

Primary

Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy.

Secondary

Compare the toxicity and side effects of these regimens in these patients.
Compare the dietary patterns of these patients.

OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral soy supplementation daily for 4 weeks.
Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation.

Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Dietary Supplement: soy isoflavones
Given orally
Dietary Supplement: soy protein isolate
Given orally
Other: placebo
Given orally

Study Arm (s)

Experimental: Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
Interventions:
- Dietary Supplement: soy isoflavones
- Dietary Supplement: soy protein isolate
Placebo Comparator: Arm II
Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.

Intervention: Other: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00345813

Other Study ID Numbers ^ICMJE

CDR0000466317, CCCWFU-98203, CCCWFU-BG03-332

Has Data Monitoring Committee

Responsible Party

Comprehensive Cancer Center of Wake Forest University

Study Sponsor ^ICMJE

Comprehensive Cancer Center of Wake Forest University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

M. Craig Hall, MD

Comprehensive Cancer Center of Wake Forest University

Information Provided By

Comprehensive Cancer Center of Wake Forest University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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