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Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345813
First Posted: June 29, 2006
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
June 28, 2006
June 29, 2006
November 29, 2017
October 2003
July 2006   (Final data collection date for primary outcome measure)
Correlation of pretreatment ER-β expression with response to soy supplementation [ Time Frame: within 21 days after completetion of supplement regimen ]
after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.
Not Provided
Complete list of historical versions of study NCT00345813 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Dietary Supplement: soy isoflavones
    Given orally
  • Dietary Supplement: soy protein isolate
    Given orally
  • Other: placebo
    Given orally
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
July 2006
July 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00345813
CDR0000466317
CCCWFU-98203
CCCWFU-BG03-332
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: M. Craig Hall, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
November 2017

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