Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer

Prostate Cancer Clinical Trial

Official title: The Molecular Effects of Nutrition Supplements (MENS) Prostate Study

Status Completed

Clinical Trial Summary

RATIONALE: The use of lycopene, a substance found in tomatoes, or omega-3 fatty acid nutritional supplements may keep cancer from growing in patients with prostate cancer.

PURPOSE: This randomized clinical trial is studying lycopene to see how well it works compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II prostate cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• Compare gene expression in normal prostate tissue (at baseline and after treatment) of patients with stage I or II adenocarcinoma of the prostate treated with lycopene vs omega-3 fatty acid nutritional supplements vs placebo.

Secondary

• Determine new candidate molecular targets for lycopene and omega-3 response pathways.

• Correlate baseline gene expression patterns, determined by cDNA array analysis, with self-reported dietary intake.

• Correlate gene expression patterns with progression or lack of progression at 12 months after study entry.

• Determine if lycopene or omega-3 supplements affect the incidence of tumor progression.

OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified according to dietary intake of tomato and fish (low tomato [< 4 servings/week], low fish [< 2 servings/week] vs low tomato, high fish [≥ 2 servings/week] vs high tomato [≥ 4 servings/week], low fish vs high tomato, high fish). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients maintain normal diet and receive oral omega-3 fatty acids placebo 3 times daily and lycopene placebo twice daily.

• Arm II: Patients receive oral lycopene twice daily and oral omega-3 fatty acids placebo 3 times daily.

• Arm III: Patients receive oral lycopene placebo twice daily and oral omega-3 fatty acids 3 times daily.

In all arms, treatment continues for up to 90 days or until post-treatment biopsy is scheduled (a maximum of 104 days) in the absence of disease progression.

Patients complete a dietary questionnaire at baseline and then for 3 days each month during study therapy. Quality of life is assessed at baseline and at 3 months.

Prostate tissue needle biopsies and blood samples are collected at baseline and at 3 months. Tissue and blood samples are examined for lycopene and omega-3 fatty acids (treatment compliance), omega-6 fatty acids, insulin-like growth factor (IGF)-1, IGF binding protein-5, and cyclooxygenase-2 gene by polymerase chain reaction, cDNA microarray hybridization, and other gene expression assays.

After completion of study treatment, patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 114 patients will be enrolled in this study. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00402285
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: April 2003
• Completion date: January 2008