Lycopene In Preventing of Prostate Cancer

Prostate Cancer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00006078
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 1
• Start date: June 2000
• Completion date: January 2005