Lycopene In Preventing of Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer. PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.

Detailed Description
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OBJECTIVES: Determine any dose limiting toxicities and the maximum tolerated dose of lycopene administered orally as a food based delivery system in healthy male subjects 18-45 years of age for the chemoprevention of prostate cancer. Determine the pharmacokinetics of this regimen in this population. Determine the dose range of this regimen to be used in the 3 month multiple dose study, based on the toxicity, pharmacokinetics and feasibility resulting from the present study in this population. OUTLINE: This is a dose-escalation study. Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains negligible carotinoid for 28 days. Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicities. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.

Official Title
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Single Dose Pharmacokinetic Study of Lycopene Delivered in a Well Defined Food-Based Lycopene Delivery System (Tomato Paste-oil Mixture) in Healthy Male Volunteers Between 18 and 45 Years of Age

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: lycopene


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions Baseline serum lycopene less than 600 nM PATIENT CHARACTERISTICS: Age: 18 to 45 Performance status: Karnofsky 100% Life expectancy: Not specified Hematopoietic: Hematologic function normal Hepatic: Liver function normal No hepatic disease Renal: Kidney function normal No renal disease Cardiovascular: No hypertension requiring medication No cardiovascular disease Normal EKG Other: No evidence of a psychiatric disorder Must be within 15% of ideal body weight based on standard weight tables No history of smoking within the past 3 months At least 72 hours since prior alcohol consumption and no history of alcohol abuse No history of gastrointestinal malabsorption or any other condition that could affect drug absorption No allergy to tomato based products No active malignancy at any site No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 14 days since prior prescription drugs No concurrent regular prescription medications At least 30 days since other prior experimental drugs No concurrent participation in any other experimental trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: lycopene|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer