NCT00093561

Lycopene in Preventing Prostate Cancer in Healthy Participants

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

• 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: Accepted

Summary

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

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lycopene

Timeline

• Start date: 2004-08-01
• Completion: 2006-02-01
• First posted: 2004-10-08
• Last updated: 2013-06-26

Locations

1 site across 1 country: United States