• Concentration of lycopene in prostatic surgical tissue at 4-7 weeks [ Designated as safety issue: No ]
  
• Change in serum lycopene concentration from baseline and at 4-7 weeks [ Designated as safety issue: No ]
  

• Ratio of testosterone (T) to dihydrotestosterone (DHT) in serum at baseline and at 4-7 weeks [ Designated as safety issue: No ]
  
• Ratio of T:DHT in prostatic surgical tissue at 4-7 weeks [ Designated as safety issue: No ]
  
• Serum concentrations of total prostate-specific antigen (PSA), free PSA, and human kallikrein 2 at baseline and at 4-7 weeks [ Designated as safety issue: No ]
  
• Growth potential assessed by the ratio of proliferation (Ki-67):apoptosis (TUNEL) in prostatic surgical tissue at 4-7 weeks [ Designated as safety issue: No ]
  
• Serum concentrations of insulin-like growth factor (IGF)-1 and IGF binding protein-3 at baseline and at 4-7 weeks [ Designated as safety issue: No ]
  
• Lymphocyte oxidative DNA damage capacity as measured by Comet assay at baseline and at 4-7 weeks [ Designated as safety issue: No ]
  
• Expression of GST-pi in prostatic surgical tissue at 4-7 weeks [ Designated as safety issue: No ]
  
• Histological characteristics of prostatic surgical tissue at 4-7 weeks [ Designated as safety issue: No ]
  
• Modulation of expression of androgen-related genes as measured by microarray in prostatic surgical tissue at 4-7 weeks [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Compare the differences in tissue concentrations of lycopene in patients with prostate cancer undergoing radical prostatectomy treated with different doses of neoadjuvant lycopene supplementation.
• Compare the change in serum lycopene concentration from baseline and at 4-7 weeks in patients treated with different doses of lycopene.

Secondary

• Determine the effect of this treatment in down-regulating 5-alpha-reductase activity by measuring the change in the ratio of testosterone (T) to dihydrotestosterone (DHT) in serum at baseline and at 4-7 weeks and the ratio of T:DHT in prostatic surgical tissue post-treatment.
• Determine the effect of this treatment in attenuating baseline blood serum concentrations of total prostate-specific antigen (PSA), free PSA, and human kallikrein 2 in these patients.
• Determine the effect of this treatment on growth potential by examining post-treatment radical prostatectomy tissue specimens for proliferative index (PI) by Ki-67 expression, apoptotic index (AI) by TUNEL assay, and PI:AI ratio in these patients.
• Determine the effect of this treatment in modulating putative biomarkers of lycopene efficacy, including serum concentrations of insulin-like growth factor (IGF)-1 and IGF binding protein-3, lymphocyte oxidative DNA damage capacity by Comet assay, and GST-pi expression in prostatic tissue from these patients.
• Compare the histological effect of different doses of lycopene on putative prognostic features, including the presence and extent of high-grade prostatic intraepithelial neoplasia, prostatitis, total tumor volume, local invasion (vascular and lymphatic, capsular, seminal vesicle), pathologic stage, Gleason score, surgical margins, and lymph node status in these patients.
• Determine the effect of this treatment in modulating the RNA expression of androgen-related genes by microarray analysis in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive oral placebo once daily.
• Arm II: Patients receive low-dose oral lycopene once daily.
• Arm III: Patients receive high-dose oral lycopene once daily. Treatment in all arms continues for 4-7 weeks.

All patients undergo radical prostatectomy after completion of treatment. Tumor samples are collected from prostatectomy for laboratory studies, including GST-pi expression by immunohistochemistry; histological analysis; microarray analysis of androgen-related genes; ratio of testosterone (T) to dihydrotestosterone (DHT); Ki-67 expression; and lycopene tumor-concentration measurement.

Patients undergo blood collection at baseline, week 4, and week 7 for laboratory studies, including serum lycopene concentration measurement; level of T or DHT by high-performance liquid chromatography/tandem mass spectrometry (HPLC/MS/MS) analysis; serum concentrations of total prostate-specific antigen (PSA), free PSA, and human kallikrein 2; lymphocyte oxidative DNA damage capacity; and serum concentrations of insulin-like growth factor (IGF)-1 and IGF binding protein-3 by radioimmunological assay.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study.