Spots Global Cancer Trial Database for Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
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Trial Identification
Brief Title: Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
Official Title: A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
Study ID: NCT00042731
Conditions
Study Description
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.
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Contact Details
Name: Nagi B. Kumar, PhD, RD, FADA
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: STUDY_CHAIR
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