Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00345813

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: placebo Drug: soy isoflavones Drug: soy protein isolate	Phase II

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer

Drug Information available for: Proteins, soy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Expression of proliferation markers (Ki67, cyclin B1, p21, and cleaved caspase 3) in normal and cancerous prostate tissue [ Designated as safety issue: No ]
Correlation of pretreatment ER-β expression with response to soy supplementation [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	October 2003
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.	Drug: soy isoflavones Given orally Drug: soy protein isolate Given orally
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.	Drug: placebo Given orally

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.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345813

Locations

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

M. Craig Hall, MD

Wake Forest University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Piedmont Urological Associates ( M. Craig Hall )
Study ID Numbers:	CDR0000466317, CCCWFU-98203, CCCWFU-BG03-332
Study First Received:	June 28, 2006
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00345813
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Disease Progression
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009