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
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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 |
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.
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 |


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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
United States, Illinois | |
University of Illinois Medical Center | |
Chicago, Illinois, United States, 60612 |
Study Chair: | Keith A. Rodvold | University of Illinois at Chicago |
ClinicalTrials.gov Identifier: | NCT00006078 |
Other Study ID Numbers: |
UIC-H-99-058 CDR0000067915 ( Registry Identifier: PDQ (Physician Data Query) ) UIC-N01-CN-85081 NCI-P00-0143 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 26, 2013 |
Last Verified: | December 2004 |
prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Lycopene Anti-Inflammatory Agents |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents |