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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

NCI-2009-00857

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18+ Years
Male

Trial Timing

Ended 16 years ago

What is this trial about?

This randomized phase II trial studies how well different doses of lycopene work in treating patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from growing or coming back after surgery.

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)