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

Not Applicable

Completed

Conditions: Prostate Cancer

Interventions: Dietary Supplement: lycopene supplement
Dietary Supplement: fish oil supplement
Other: Placebo

Registration Number: NCT00402285

Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lycopene supplement	lycopene supplement	Two 15mg lycopene capsules daily for 3 months.
fish oil supplement	fish oil supplement	1g fish oil capsule daily for 3 months.
placebo	Placebo	placebos for lycopene and fish oil.

Primary Outcome Measures

Name	Time	Method
Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2	baseline through 3 month	Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.

Secondary Outcome Measures