Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Prevention	Completed	50 to 80	NCI	MCC-0002 NCI-4031, NCI-P01-0195, NCT00027950

Objectives

1. 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.

Entry 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]

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)

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/m²)
• 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)

Expected Enrollment

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

Outcomes

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)

Change in nutritional intake
Change in anthropometric measurements (height, weight, BMI) at baseline and post study

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Nagi Kumar, PhD, RD, FADA, Protocol chair		Ph: 813-745-6885; 888-663-3488

Registry Information
Official Title		The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
Trial Start Date		2001-10-19
Trial Completion Date		2005-09-29
Registered in ClinicalTrials.gov		NCT00027950
Date Submitted to PDQ		2001-10-17
Information Last Verified		2006-06-06

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