Lycopene in Preventing Prostate Cancer in Healthy Participants

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 6, 2004
Last updated: June 25, 2013
Last verified: November 2006

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.

Condition Intervention Phase
Prostate Cancer
Dietary Supplement: lycopene
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity by blood chemistries and patient histories at 4 weeks after treatment [ Designated as safety issue: Yes ]
  • Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define dose range by blood lycopene concentrations at 4 weeks after treatment [ Designated as safety issue: No ]

Study Start Date: August 2004
Study Completion Date: February 2006
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes


  • Healthy participants in good medical condition

    • No chronic medical conditions
    • No regular use of prescription medications
    • No evidence of psychiatric disorder
    • Non-smoker

      • Former smokers allowed provided they have not smoked within the past 3 months
    • No history of alcohol abuse
  • Serum lycopene concentration < 700 nM



  • 18 to 45

Performance status

  • Karnofsky 100%

Life expectancy

  • Not specified


  • Hemoglobin ≥ 13.0 g/dL
  • WBC ≥ 4,000/mm^3
  • Platelet count 150,000-400,000/mm^3


  • AST and ALT ≤ 75 U/L
  • Bilirubin ≤ 2.0 mg/dL
  • No liver disease


  • Creatinine ≤ 1.5 mg/dL
  • No renal disease


  • No cardiovascular disease
  • No abnormal EKG


  • Within 15% of ideal body weight
  • No history of gastrointestinal malabsorption or other condition that would preclude drug absorption
  • No alcohol consumption within the past 72 hours
  • No allergy to tomato-based products
  • No history of cancer
  • No diabetes mellitus
  • No other illness that would preclude study participation


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • At least 4 weeks since prior experimental drugs
  • More than 14 days since prior prescription drugs
  • No concurrent participation in another experimental trial
  • No concurrent prescription drugs
  Contacts and Locations
Please refer to this study by its identifier: NCT00093561

United States, Illinois
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Principal Investigator: Keith A. Rodvold University of Illinois at Chicago
  More Information

Additional Information:
No publications provided Identifier: NCT00093561     History of Changes
Other Study ID Numbers: UIC-2004-0040, CDR0000389223
Study First Received: October 6, 2004
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses processed this record on April 23, 2014