Lycopene in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00068731
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: Phase 2
• Start date: January 2004
• Completion date: October 2009