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Lycopene In Preventing of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00006078
Recruitment Status : Completed
First Posted : January 27, 2003
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 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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
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
Study Start Date : June 2000
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Lycopene

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:   No


  • Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions
  • Baseline serum lycopene less than 600 nM



  • 18 to 45

Performance status:

  • Karnofsky 100%

Life expectancy:

  • Not specified


  • Hematologic function normal


  • Liver function normal
  • No hepatic disease


  • Kidney function normal
  • No renal disease


  • No hypertension requiring medication
  • No cardiovascular disease
  • Normal EKG


  • No evidence of a psychiatric disorder
  • Must be within 15% of ideal body weight based on standard weight tables
  • No history of smoking within the past 3 months
  • At least 72 hours since prior alcohol consumption and no history of alcohol abuse
  • No history of gastrointestinal malabsorption or any other condition that could affect drug absorption
  • No allergy to tomato based products
  • No active malignancy at any site
  • No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus)


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • At least 14 days since prior prescription drugs
  • No concurrent regular prescription medications
  • At least 30 days since other prior experimental drugs
  • No concurrent participation in any other experimental trial

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 ClinicalTrials.gov identifier (NCT number): NCT00006078

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United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Cancer Institute (NCI)
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Study Chair: Keith A. Rodvold University of Illinois at Chicago
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ClinicalTrials.gov Identifier: NCT00006078    
Other Study ID Numbers: UIC-H-99-058
CDR0000067915 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: December 2004
Keywords provided by National Cancer Institute (NCI):
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents