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CompletedNCT00416325Updated Jun 26, 2013

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

A Phase 1 interventional study of lycopene and laboratory biomarker analysis in Prostate Cancer, sponsored by University of Illinois at Chicago. Completed. Open to male participants aged 35 Years to 75 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
Enrollment
18
Ages
35 Years to 75 Years
Sex
Male
01

Study 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.

Read the 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.

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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.

This study's planned enrollment of 18 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

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
35 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Enrollment
18 participants (estimated)

Interventions

  • Dietary supplementlycopene
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Toxicity as measured by NCI CTC v2.0

  2. Feasibility of daily consumption of prescribed volumes of the formulation

  3. Serum lycopene levels, including other carotenoids and lipid soluble vitamins, at 1 and 3 months

  4. Pharmacokinetics at 1 and 3 months

  5. Tissue distribution of lycopene (oral mucosa and prostate tissue)

  6. Modulation of surrogate endpoint biomarkers which include oxidative stress in blood, oral mucosa, and prostate tissue

  7. Modulation of serum prostate-specific antigen

  8. Cellular proliferation as measured by proliferating cell nuclear antigen (PCNA)

  9. Apoptosis as measured by Terminal deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling in prostate tissue

  10. Serum levels of insulin-like growth factor (IGF-1) and the modulation of prostate histology (prostatic intraepithelial neoplasia [PIN], when and if present)

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 26422197 ↗
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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 ↗
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Registry details

Key details

Study ID
NCT00416325
Lead sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
First posted
Dec 28, 2006
Completion
Sep 2006
Last update
Jun 26, 2013

Study contacts

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

Not currently enrolling

This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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