Lycopene in Preventing Prostate Cancer in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093561
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: lycopene Phase 1

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.

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : August 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Primary Outcome Measures :
  1. Toxicity by blood chemistries and patient histories at 4 weeks after treatment
  2. Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment

Secondary Outcome Measures :
  1. Define dose range by blood lycopene concentrations at 4 weeks after treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093561

United States, Illinois
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Cancer Institute (NCI)
Principal Investigator: Keith A. Rodvold University of Illinois at Chicago Identifier: NCT00093561     History of Changes
Other Study ID Numbers: UIC-2004-0040
CDR0000389223 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: November 2006

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
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents