Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of 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.
Dietary Supplement: lycopene
Other: laboratory biomarker analysis
|Study Design:||Primary Purpose: 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|
- 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 ]
|Study Completion Date:||September 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416325
|Principal Investigator:||Keith A. Rodvold||University of Illinois at Chicago|