Status:
COMPLETED
Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 to...
Detailed Description
PRIMARY OBJECTIVES: I. Compare the differences in tissue concentrations of lycopene in patients with prostate cancer undergoing radical prostatectomy treated with different doses of neoadjuvant lycop...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00450749
Start Date
February 1 2008
End Date
May 1 2010
Last Update
December 18 2019
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030