Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer
Sponsored by National Cancer Institute (NCI)
About this trial
Last updated 6 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 16 years ago
What is this trial about?
What are the Participation Requirements?
Criteria: * Creatinine normal * Biopsy-confirmed adenocarcinoma of the prostate * Localized disease * Planned radical prostatectomy * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * WBC >= 3,000/mm^3 * Platelet count >= 100,000/mm^3 * Bilirubin normal * AST and ALT =< 2.5 times upper limit of normal * Fertile patients must use effective barrier contraception * No other invasive cancer (except nonmelanoma skin cancer) within the past 2 years * Patients who received curative treatment and have shown no evidence of recurrence within the past 2 years are eligible * No history of allergic reactions attributed to compounds of similar chemical or biological composition to lycopene (e.g., other carotenoids, including lutein and beta-carotene) * More than 30 days since prior regular (> once weekly) lycopene supplementation (>= 15 mg/day) and meets the following criteria: no more than 2 servings of tomato sauce, juice, or soup per week; no more than 4 servings of grapefruit, raw tomato, or watermelon per week * Must not consume 1 serving of tomato sauce, juice, or soup per week AND more than 2 servings of grapefruit, raw tomato, or watermelon per week * More than 30 days since prior and no concurrent investigational medication * No concurrent chemotherapy, radiotherapy, hormonal therapy, or immunotherapy * No history of allergy to foods containing lycopene (e.g., tomatoes or tomato products, watermelon, guava, and pink grapefruit) * No concurrent uncontrolled illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness/social situations that would limit compliance with study requirements * No prior therapy for prostate cancer, including radiotherapy to the prostate or pelvis, androgen ablation, or antiandrogen systemic therapy * No other concurrent lycopene (>= 15 mg/day)
