Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer

June 25, 2013 updated by: University of Illinois at Chicago

Phase I Multiple Dose Pharmacokinetic Study of Lycopene Delivered in a Well-Defined Food-Based Lycopene Delivery System (Tomato Paste-Oil Mixture) in Patients at Increased Risk for Developing Prostate Cancer

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming in patients at high risk of developing prostate cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in patients who are at high risk of developing prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Define the toxicity and safety of lycopene administered as a food-based delivery system as a chemoprevention agent in patients who are at a high risk of developing prostate cancer.
  • Define the pharmacokinetics and tissue distribution in patients receiving this regimen.

  • Characterize surrogate endpoint biomarkers (SEBs) in the peripheral blood, buccal mucosa, and the prostate itself, which will provide evidence of biological activity relevant to a chemoprevention effect.

    • Characterize the oxidative stress state of the individual by studies of DNA oxidation in the prostate and buccal mucosa, as well as DNA oxidation and lipid peroxidation within the peripheral blood.
    • Define the effects of lycopene through a food delivery system on prostate histology (prostatic intraepithelial neoplasia), markers of cellular proliferation [PCNA], and apoptosis in the prostate.
    • Evaluate the effects of lycopene on the serum levels of total prostate-specific antigen (PSA), free PSA, and PSA density.
  • Provide the basic knowledge in reference to toxicity, pharmacokinetics, and SEBs needed to proceed to a large phase II or III lycopene study in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral lycopene in tomato paste and olive oil, once, twice, or three times daily for 3 months.

Cohorts of 6 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 6 patients experience dose-limiting toxicity.

Patients undergo buccal scrapings and blood collection periodically during study for pharmacokinetics and biomarker studies.

After completion of study treatment, patients are followed for 1 month.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Elevated prostate-specific antigen (PSA), meeting 1 of the following criteria:

    • PSA > 4.0 ng/mL for patients at any age
    • PSA > 2.0 ng/mL for patients 35 to 49 years of age
    • PSA rise (velocity) of > 0.75 ng/mL over the past year

  • Has undergone a prostate biopsy* (following findings of elevated PSA) within the past 180 days that failed to reveal prostate cancer

    • Prostate intraepithelial neoplasia allowed NOTE: *At least 4 core biopsies are considered acceptable

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 80-100%
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2 times upper limit of normal
  • Creatinine ≤ 2.0 mg/dL
  • WBC ≥ 3,000/mm^3
  • Hemoglobin ≥ 11.0 g/dL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 125,000/mm^3
  • No history of gastrointestinal malabsorption or other condition affecting drug absorption
  • No history of food allergy to tomato-based products
  • No history of any chronic medical condition that, in the judgment of the investigator, may pose threat or additional risk to the patient (including a current history of alcohol or drug abuse)
  • No active history of cancer or other illnesses that, in the opinion of the investigator, could represent a threat to patient's life, including congestive heart failure or uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

  • No participation in any other experimental trial within the past 4 weeks
  • No concurrent chronic use of nonsteroidal anti-inflammatory drugs
  • No concurrent participation in another experimental trial
  • No concurrent supplements (except multivitamins), including herbal and soy products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity as measured by NCI CTC v2.0
Feasibility of daily consumption of prescribed volumes of the formulation
Serum lycopene levels, including other carotenoids and lipid soluble vitamins, at 1 and 3 months
Pharmacokinetics at 1 and 3 months
Tissue distribution of lycopene (oral mucosa and prostate tissue)
Modulation of surrogate endpoint biomarkers which include oxidative stress in blood, oral mucosa, and prostate tissue
Modulation of serum prostate-specific antigen
Cellular proliferation as measured by proliferating cell nuclear antigen (PCNA)
Apoptosis as measured by Terminal deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling in prostate tissue
Serum levels of insulin-like growth factor (IGF-1) and the modulation of prostate histology (prostatic intraepithelial neoplasia [PIN], when and if present)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Keith A. Rodvold, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

December 27, 2006

First Submitted That Met QC Criteria

December 27, 2006

First Posted (Estimate)

December 28, 2006

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIC-2000-0931
  • CDR0000467322 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe