Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00345813
First received: June 28, 2006
Last updated: September 29, 2014
Last verified: July 2013
  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
Dietary Supplement: soy isoflavones
Dietary Supplement: soy protein isolate
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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.


Enrollment: 62
Study Start Date: October 2003
Estimated Study Completion Date: November 2016
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
Dietary Supplement: soy isoflavones
Given orally
Dietary Supplement: soy protein isolate
Given orally
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.
Other: 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: M. Craig Hall, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00345813     History of Changes
Other Study ID Numbers: CDR0000466317, CCCWFU-98203, CCCWFU-BG03-332
Study First Received: June 28, 2006
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014