Lycopene In Preventing of Prostate Cancer

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006078

Enrollment

Unknown

Registered

2003-01-27

Start date

2000-06-30

Completion date

2005-01-31

Last updated

2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTlycopene

Study design

Primary purpose

PREVENTION

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026