Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
- Conditions
- Prostate Cancer
- Interventions
- Procedure: neoadjuvant therapyDietary Supplement: soy isoflavonesOther: Placebo
- Registration Number
- NCT00078923
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- 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 prostate cancer.
PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo neoadjuvant therapy Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks. Placebo Placebo Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks. Soy isoflavones and placebo soy isoflavones Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks. Soy isoflavones and placebo neoadjuvant therapy Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks. Soy isoflavones and placebo Placebo Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks. Soy Isoflavones/Placebo soy isoflavones Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks. Soy Isoflavones/Placebo neoadjuvant therapy Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks. Soy Isoflavones/Placebo Placebo Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks. Soy Isoflavones soy isoflavones Arm IV: Arm III: Patients receive oral soy isoflavones (PTI G-2535) 600 mg genistein capsules by mouth daily for 3 weeks.
- Primary Outcome Measures
Name Time Method Oxidative DNA damage as measured by 5-hydroxymethyluridine level at 3 weeks Lipid oxidation as measured by 8-isoprostane level at 3 weeks
- Secondary Outcome Measures
Name Time Method Tumor size, grade, and extension at 3 weeks Prostate-specific antigen and prostatic intraepithelial neoplasia grade at 3 weeks Biomarkers of cell growth, differentiation, and apoptosis at 3 weeks Toxicity as measured by number and grade of adverse events at 3 weeks
Trial Locations
- Locations (1)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States