Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345813
• Other study ID #: CDR0000466317
• Secondary ID: CCCWFU-98203CCCW
• Status: Completed
• Phase: Phase 2
• Start date: October 2003
• Est. completion date: July 2006

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• soy isoflavones
Given orally
• soy protein isolate
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of pretreatment ER-ß expression with response to soy supplementation	after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-ß expression will be measured.	within 21 days after completetion of supplement regimen