Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer - Full Text View

Sponsors and Collaborators:	University of Illinois National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416325

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: lycopene Other: laboratory biomarker analysis	Phase I

Study Type:	Interventional
Study Design:	Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Toxicity as measured by NCI CTC v2.0 [ Designated as safety issue: Yes ]
Feasibility of daily consumption of prescribed volumes of the formulation [ Designated as safety issue: No ]
Serum lycopene levels, including other carotenoids and lipid soluble vitamins, at 1 and 3 months [ Designated as safety issue: No ]
Pharmacokinetics at 1 and 3 months [ Designated as safety issue: No ]
Tissue distribution of lycopene (oral mucosa and prostate tissue) [ Designated as safety issue: No ]
Modulation of surrogate endpoint biomarkers which include oxidative stress in blood, oral mucosa, and prostate tissue [ Designated as safety issue: No ]
Modulation of serum prostate-specific antigen [ Designated as safety issue: No ]
Cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) [ Designated as safety issue: No ]
Apoptosis as measured by Terminal deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling in prostate tissue [ Designated as safety issue: No ]
Serum levels of insulin-like growth factor (IGF-1) and the modulation of prostate histology (prostatic intraepithelial neoplasia [PIN], when and if present) [ Designated as safety issue: No ]

Estimated Enrollment:

18

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.

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416325

Sponsors and Collaborators

University of Illinois

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Keith A. Rodvold

University of Illinois

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000467322, UIC-2000-0931
Study First Received:	December 27, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00416325 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

prostate cancer

Study placed in the following topic categories:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Prostatic Diseases
Genital Neoplasms, Male

Lycopene
Urogenital Neoplasms
Tomato
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lycopene
Physiological Effects of Drugs

Urogenital Neoplasms
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009