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CompletedNCT00006078Updated Jun 26, 2013

Lycopene In Preventing of Prostate Cancer

A Phase 1 interventional study of lycopene in Prostate Cancer, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-06-26.

Sponsored by University of Illinois at Chicago · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 45

Performance status:

  • Karnofsky 100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Hematologic function normal

Hepatic:

  • Liver function normal
  • No hepatic disease

Renal:

  • Kidney function normal
  • No renal disease

Cardiovascular:

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

Other:

  • 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)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Prevention

Interventions

  • Dietary supplementlycopene
06

Study locations

1 site
  • University of Illinois Medical Center
    Chicago, Illinois 60612, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00006078
Lead sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Jun 2000
Completion
Jan 2005
Last update
Jun 26, 2013

Study contacts

Keith A. Rodvold
study chair · University of Illinois at Chicago
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2004. You cannot join it, but the record below documents what was studied.

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