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

This study is currently recruiting patients.

Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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: Randomized clinical trial to study the effectiveness of isoflavones in preventing further development of cancer in patients who have stage I or stage II prostate cancer.

Condition Treatment or Intervention
stage I prostate cancer
stage II prostate cancer
 Drug: multivitamins
 Drug: soy protein isolate
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
 Procedure: complementary and alternative therapy
 Procedure: dietary intervention
 Procedure: dietary modification
 Procedure: herbal medicine / botanical therapy
 Procedure: nutritional supplementation
 Procedure: phytoestrogen therapy

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Randomized Study of Isoflavones in Reducing Risk Factors in Patients With Stage I or II Prostate Cancer

Further Study Details: 

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   -   80 Years,  Genders Eligible for Study:  Both

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:

Chemotherapy:

Endocrine therapy:

Radiotherapy:

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)

Location and Contact Information


Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2944    david.king@baannerhealth.com 

Florida
      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612-9497,  United States; Recruiting
N. B. Kumar, PhD, RD, FADA  813-903-6889 

      Urology Associates of Pinnellas County, Clearwater,  Florida,  33756,  United States; Recruiting
Craig S. Barkley, MD  727-441-1508    cbarkley@tampabay.rr.com 

Georgia
      Cancer Care and Research Pavilion at St. Joseph's/Candler, Savannah,  Georgia,  31405-6015,  United States; Recruiting
Mark A. Taylor, MD  912-819-6194    mtayl03@yahoo.com 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4880    jwg684@sprg.mercy.net 

      Hulston Cancer Center at Cox Medical Center South, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-5257 

      St. John's Regional Health Center, Springfield,  Missouri,  65804-2263,  United States; Recruiting
John Wendall Goodwin, MD  417-269-6513 

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-6125    lwong@swmail.sw.org 

Study chairs or principal investigators

N. B. Kumar, PhD, RD, FADA,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069097; MCC-0002; NCI-4031; NCI-P01-0195; NCT00027950
Record last reviewed:  February 2005
Last Updated:  March 10, 2005
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027950
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005