NCT00006078

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lycopene

Timeline

• Start date: 2000-06-01
• Completion: 2005-01-01
• First posted: 2003-01-27
• Last updated: 2013-06-26

Locations

1 site across 1 country: United States