The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
- 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.
- 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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2
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.
baseline through 3 month
Peter R. Carroll, MD
University of California, San Francisco
United States: Federal Government
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|