Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
- Conditions
- Prostate Cancer
- Interventions
- Dietary Supplement: LycopeneDietary Supplement: Soy isoflavonesDietary Supplement: Multivitamin
- Registration Number
- NCT00042731
- Brief Summary
RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
- Detailed Description
OBJECTIVES:
* Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer.
* Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients.
* Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients.
* Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients.
* Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral isoflavones with multivitamin Soy isoflavones Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. Oral lycopene with multivitamin Lycopene Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. Oral lycopene with multivitamin Multivitamin Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. Multiple vitamin alone Multivitamin Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. Oral isoflavones with multivitamin Multivitamin Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
- Primary Outcome Measures
Name Time Method Occurrences of Treatment Effect on Biomarkers in Each Group 4 years Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision
- Secondary Outcome Measures
Name Time Method Occurrences of Plasma Level Changes for Each Group 4 years Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention
Occurrence of Tissue Level Increases 4 years Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention
Occurrences of Disease Progression for Each Group 4 years Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention
Occurrences of Hormonal Effect 4 years Effect of isoflavones and lycopene on serum steroid hormones as measured by sex-hormone-binding globulin, estradiol, and free testosterone at baseline and post-study intervention
Trial Locations
- Locations (5)
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
🇺🇸Savannah, Georgia, United States