Status:
COMPLETED
Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostat...
Detailed Description
OBJECTIVES: * Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Stage T1c or T2
- Disease confined to the prostate gland
- Planning to undergo radical prostatectomy within the next 3-4 weeks
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- ALT and AST less than 2 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2 times ULN
- Renal
- Not specified
- Other
- Fertile patients must use effective barrier contraception
- Medically cleared for surgery
- No concurrent thyroid disease
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior biological therapy for prostate cancer
- No concurrent biological agents
- Chemotherapy
- No prior chemotherapy for prostate cancer
- No concurrent chemotherapy
- Endocrine therapy
- No prior hormonal therapy for prostate cancer
- No concurrent thyroid hormone replacement medication
- No concurrent hormonal therapy
- Radiotherapy
- Not specified
- Surgery
- See Disease Characteristics
- Other
- At least 3 months since prior high-dose nutritional supplements
- No concurrent regular use (more than once weekly) of soy products greater than 50 g of soy protein or 50 mg of soy isoflavone
- No concurrent high-dose nutritional supplements
- Standard-dose single multivitamin tablet (e.g., Centrum™) allowed
- No concurrent herbs
- No concurrent soy foods
- No other concurrent isoflavone supplements
- No other concurrent antineoplastic agents
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00078923
Start Date
November 1 2001
End Date
May 1 2010
Last Update
March 5 2014
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379