Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy
- 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
- 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
- Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones
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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Oxidative DNA damage as measured by 5-hydroxymethyluridine level at 3 weeks
Omer Kucuk, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|