Spots Global Cancer Trial Database for Lycopene in Treating Patients With Metastatic Prostate Cancer

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Trial Identification

Brief Title: Lycopene in Treating Patients With Metastatic Prostate Cancer

Official Title: A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation

Study ID: NCT00068731

Conditions

Prostate Cancer

Interventions

lycopene

Study Description

Brief Summary: RATIONALE: Lycopene, a substance found in tomatoes, may lower prostate-specific antigen (PSA) levels and slow or prevent the development of prostate cancer. PURPOSE: Phase II trial to study the effectiveness of lycopene in treating patients who have asymptomatic metastatic prostate cancer and a rising PSA level.

Detailed Description: OBJECTIVES: Primary * Determine the percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene. Secondary * Determine the response duration of PSA decline in patients treated with this therapy. * Determine the time to the first consistent PSA increase in patients treated with this therapy. * Determine whether a decline in PSA coincides with evidence of disease regression on physical examination or radiographic assessment in patients treated with this therapy. * Determine the adverse event profile of this therapy in these patients. * Determine the factors that motivate prostate cancer patients to enroll in a nutritional-based therapy study. OUTLINE: This is a multicenter study. Patients receive oral lycopene twice daily on days 1-28. Courses repeat every 28 days for at least 4 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.