Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carotenoids; Lycopene

Criteria

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)