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Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer

This study has been completed.

Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027950
  Purpose

RATIONALE: Soy isoflavones may reduce the risk of some types of cancer. It is not yet known if isoflavones are effective in preventing the development of prostate cancer.

PURPOSE: This randomized phase III trial is studying the effectiveness of isoflavones in preventing further development of cancer in patients who have stage I or stage II prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: multivitamin
Drug: soy isoflavones
Phase III

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Proteins, soy   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Active Control
Official Title:   The Specific Role of Isoflavones in Reducing Prostate Cancer Risk

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

Primary Outcome Measures:
  • Effect on prostate cancer risk parameters as measured by free testosterone, sex-hormone-binding globulin, estradiol, and prostate-specific antigen at baseline and post-study intervention (12 weeks) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in nutritional intake [ Designated as safety issue: No ]
  • Change in anthropometric measurements (height, weight, BMI) at baseline and post study [ Designated as safety issue: No ]

Estimated Enrollment:   148
Study Start Date:   October 2001
Primary Completion Date:   September 2005 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the effectiveness of isoflavones in producing a change in risk parameters, such as decrease in free testosterone, increase in sex-hormone-binding globulin and estradiol, and decrease in tumor progression and volume, as measured by decreasing prostate-specific antigen in patients with stage I or II prostate cancer.

OUTLINE: This is a randomized, double-blind study. Patients are stratified according to Gleason score (2-4 vs 5-6). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral isoflavones twice daily and an oral multivitamin once daily for 12 weeks.
  • Arm II: Patients receive oral placebo twice daily and an oral multivitamin once daily for 12 weeks.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study within 3 years.

  Eligibility
Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage I or II prostate cancer

    • Gleason score 2-6* NOTE: *Patients with a Gleason primary pattern 4 (4 + 1 or 4 + 2) are ineligible

PATIENT CHARACTERISTICS:

Age:

  • 50 to 80

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No known history of hepatic disease

Renal:

  • No known history of renal disease

Other:

  • Close to ideal body weight (body mass index no greater than 32 kg/m^2)
  • No known history of thyroid disease
  • No allergy to study agent
  • No other prior malignancy except nonmelanoma skin cancer
  • No evidence of prostatitis or urinary tract infection
  • Fertile patients must use effective contraception
  • Omnivorous diet (no vegan or vegetarian diets)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior or concurrent biologic therapy for prostate cancer

Chemotherapy:

  • No prior or concurrent chemotherapy for prostate cancer

Endocrine therapy:

  • No prior or concurrent endocrine therapy for prostate cancer
  • No concurrent thyroid hormone replacement medications

Radiotherapy:

  • No prior or concurrent radiotherapy for prostate cancer

Surgery:

  • No concurrent surgery

Other:

  • At least 30 days since prior antibiotics
  • At least 30 days since prior ingestion of a diet high in soy products
  • No other prior or concurrent therapy for prostate cancer
  • No concurrent diet high in soy products
  • No concurrent nutritional supplements (e.g., retinoids, beta-carotene, and isoflavones)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027950

Locations
United States, Arizona
CCOP - Western Regional, Arizona    
      Phoenix, Arizona, United States, 85006-2726
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida    
      Tampa, Florida, United States, 33612-9497
United States, Georgia
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler    
      Savannah, Georgia, United States, 31405-6015
United States, Texas
CCOP - Scott and White Hospital    
      Temple, Texas, United States, 76508

Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Nagi B. Kumar, PhD, RD, FADA     H. Lee Moffitt Cancer Center and Research Institute    
  More Information


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

Study ID Numbers:   CDR0000069097, MCC-0002, NCI-4031, NCI-P01-0195
First Received:   December 7, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00027950
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer  
stage II prostate cancer  

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on December 03, 2008




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