Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy
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 isoflavones before radical prostatectomy.
- Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated
with these regimens.
- Determine the potential response, in terms of tumor and prostatic intraepithelial
neoplasia grade and volume, extraprostatic extension, and serum prostate-specific
antigen level, in patients treated with soy isoflavones and in those treated with
placebo.
- Determine the safety of soy isoflavone supplementation in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study.
Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1
of 4 treatment arms.
- Arm I (control group): Patients receive oral placebo once daily.
- Arm II: Patients receive oral soy isoflavones and oral placebo once daily.
- Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once
daily.
- Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones
once daily.
In all arms, treatment continues for 2-6 weeks (depending on the time from study entry to
planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical
prostatectomy.
Patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this
study within 12.5 months.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
Oxidative DNA damage as measured by 5-hydroxymethyluridine level at 3 weeks
Safety Issue:
No
Principal Investigator
Omer Kucuk, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000353197
NCT ID:
NCT00078923
Start Date:
November 2001
Completion Date:
May 2010
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage II prostate cancer
- adenocarcinoma of the prostate
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
