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

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