NCT00416325

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
Last Updated

June 26, 2013

Status Verified

September 1, 2006

First QC Date

December 27, 2006

Last Update Submit

June 25, 2013

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (10)

  • 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)

Interventions

lycopeneDIETARY_SUPPLEMENT
laboratory biomarker analysisOTHER

Eligibility Criteria

Age35 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Gann PH, Deaton RJ, Rueter EE, van Breemen RB, Nonn L, Macias V, Han M, Ananthanarayanan V. A Phase II Randomized Trial of Lycopene-Rich Tomato Extract Among Men with High-Grade Prostatic Intraepithelial Neoplasia. Nutr Cancer. 2015;67(7):1104-12. doi: 10.1080/01635581.2015.1075560.

    PMID: 26422197DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Keith A. Rodvold

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Completion

September 1, 2006

Last Updated

June 26, 2013

Record last verified: 2006-09