Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: placebo; therapeutic conventional surgery; laboratory biomarker analysis; lycopene
Intervention description: Given PO; Undergo radical prostatectomy; Correlative studies; Given PO
Intervention MeSH terms: Lycopene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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)