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The Specific Role of Isoflavones in Reducing Prostate Cancer Risk


Phase 3
50 Years
80 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

The Specific Role of Isoflavones in Reducing Prostate Cancer Risk


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

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)

Safety Issue:

No

Principal Investigator

Nagi B. Kumar, PhD, RD, FADA

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000069097

NCT ID:

NCT00027950

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

Name

Location

CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - Scott and White HospitalTemple, Texas  76508
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405