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Lycopene In Preventing of Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lycopene
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
June 25, 2013
Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006078
Brief Title
Lycopene In Preventing of Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
lycopene

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith A. Rodvold
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Lycopene In Preventing of Prostate Cancer

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