Spots Global Cancer Trial Database for Lycopene in Preventing Prostate Cancer in Healthy Participants

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Trial Identification

Brief Title: Lycopene in Preventing Prostate Cancer in Healthy Participants

Official Title: 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

Study ID: NCT00093561

Conditions

Prostate Cancer

Interventions

lycopene

Study Description

Brief 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.