Lycopene in Preventing Prostate Cancer in Healthy Participants

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer. PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.

Detailed Description
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OBJECTIVES: Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants. Determine the pharmacokinetics of this agent in these participants. Determine the dose range of this agent in these participants. OUTLINE: This is a dose-escalation study. Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1. Cohorts of 5 participants 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 participants experience dose-limiting toxicity. Participants are evaluated periodically for 28 days. PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.

Official Title
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Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to 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: Healthy participants in good medical condition No chronic medical conditions No regular use of prescription medications No evidence of psychiatric disorder Non-smoker Former smokers allowed provided they have not smoked within the past 3 months No history of alcohol abuse Serum lycopene concentration < 700 nM PATIENT CHARACTERISTICS: Age 18 to 45 Performance status Karnofsky 100% Life expectancy Not specified Hematopoietic Hemoglobin ≥ 13.0 g/dL WBC ≥ 4,000/mm^3 Platelet count 150,000-400,000/mm^3 Hepatic AST and ALT ≤ 75 U/L Bilirubin ≤ 2.0 mg/dL No liver disease Renal Creatinine ≤ 1.5 mg/dL No renal disease Cardiovascular No cardiovascular disease No abnormal EKG Other Within 15% of ideal body weight No history of gastrointestinal malabsorption or other condition that would preclude drug absorption No alcohol consumption within the past 72 hours No allergy to tomato-based products No history of cancer No diabetes mellitus No other illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 4 weeks since prior experimental drugs More than 14 days since prior prescription drugs No concurrent participation in another experimental trial No concurrent prescription drugs

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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Accepts Healthy Volunteers

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 |
| --- | --- | --- |
| Toxicity by blood chemistries and patient histories at 4 weeks after treatment |  |  | 
| Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define dose range by blood lycopene concentrations at 4 weeks after treatment |  |  | 

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