Prostate Cancer Clinical Trial
Lycopene in Healthy Male Participants
Summary
This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.
Full Description
OBJECTIVES:
I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.
II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.
III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.
OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.
Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.
Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.
PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers judged to be in good medical condition based on history and physical exam
Karnofsky performance status 100%
AST and ALT ≤ 75 IU/L
Bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 1.5 mg/dL
Hemoglobin ≥ 13.0 g/dL
WBC ≥ 4,000/mm³
Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³
Must be within height and weight standards identified by Metropolitan Life scales
Nonsmoker (for ≥ 3 months)
No history of alcohol abuse
No history of gastrointestinal malabsorption or other condition that could affect drug absorption
No history of a psychiatric condition
No chronic medical condition
No active history of any of the following:
Cancer
Liver disease
Cardiovascular disease
Renal disease
Diabetes mellitus
Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life
No allergy to tomato-based products
No lycopene in the diet for ≥ 14 days
At least 4 weeks since prior and no other concurrent experimental medications
No concurrent participation in another experimental study
No concurrent use of regular prescription medication or over-the-counter medications
No concurrent vitamin, mineral, or herbal supplements
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There is 1 Location for this study
Chicago Illinois, 60612, United States
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