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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00402285
• Date of registration: 20/11/2006
• Primary sponsor: University of California, San Francisco
• Public title: Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
• Scientific title: The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
• Date of first enrolment: April 2003
• Target sample size: 114
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00402285
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Peter R. Carroll, MD
• Affiliation: University of California, San Francisco

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate meeting the following
criteria:

- Newly diagnosed disease

- Small cell acinar type

- Gleason score = 6 with no pattern 4 or 5 histology

- Gleason pattern 4 seen as a microfocus (< 2 mm in length) allowed

- Stage I-II (T1 or T2a) disease

- Must have had an extended pattern biopsy (defined as 8+ cores) within the past 2
years

- Patients meeting all of the eligibility criteria except for the aforementioned
extended pattern biopsy within the past two years may enroll in the study if
they have an extended pattern clinical biopsy scheduled no more than 6 weeks
before beginning study treatment AND are willing to have an additional 4 biopsy
cores

- No more than 33% of biopsy cores positive

- 33% or more of biopsy cores positive due to microfoci of adenocarcinoma allowed

- No more than 50% of the length of a tumor core involved by carcinoma

- Watchful waiting planned as primary treatment strategy

- Must have 3 serum prostate-specific antigen (PSA) level readings taken = 2 weeks
apart over the past year

- PSA = 10.0 ng/mL

- PSA < 15 ng/mL in patients with benign prostatic hyperplasia or prostatitis
allowed

- PSA doubling time = 3 months

PATIENT CHARACTERISTICS:

- Life expectancy = 3 months

- ECOG performance status 0-2

- No history of allergic reactions attributed to tomatoes, fish, soybean oil, gelatin
capsules, or compounds of similar chemical or biologic composition to lycopene
(carotenoids) or fish oil (omega-3 fatty acids)

- No uncontrolled intercurrent illness including, but not limited to, the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would limit study compliance

PRIOR CONCURRENT THERAPY:

- No prior or concurrent treatment for prostate cancer, including surgery, radiation,
hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin,
megestrol, nilutamide, diethylstilbestrol/estrogen), chemotherapy, PC-SPES, or
investigational agents

- More than 4 weeks since prior and no concurrent lycopene, fish oil (omega-3 fatty
acids), or any other preparation intended to supplement levels of omega-3 unsaturated
fatty acids

- More than 4 weeks since prior and no concurrent finasteride, dutasteride, saw
palmetto or any other herbal/nutritional preparation indicated to affect hormone
levels

- More than 1 month since prior nonsteroidal anti-inflammatory drugs (NSAIDs),
cyclooxygenase-2 (COX-2) inhibitors, and/or aspirin for > 7 days duration

- No concurrent NSAIDs, COX-2 inhibitors, or aspirin



Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Dietary Supplement: lycopene

Dietary Supplement: omega-3 fatty acid

Genetic: gene expression analysis

Genetic: microarray analysis

Genetic: polymerase chain reaction

Procedure: biopsy

Procedure: complementary or alternative medicine procedure

Procedure: quality-of-life assessment

Primary Outcome(s)

2-fold + or - change in mRNA transcript level receiving lycopene or omega-3 fatty acids vs placebo by quantitative PCR comparing insulin-like growth factor 1 and COX-2 genes at baseline with normal prostate biopsies at 3 months [Time Frame: No]

Secondary Outcome(s)

Correlation of gene expression patterns (determined by cDNA array analysis) with disease progression or lack of progression at 12 months [Time Frame: No]

Correlation of gene expression patterns (determined by cDNA array analysis) with self-reported dietary intake [Time Frame: No]

Incidence of tumor progression [Time Frame: No]

New candidate molecular targets for lycopene and omega-3 response pathways by cDNA microarray [Time Frame: No]

Secondary ID(s)

CDR0000505501

UCSF-03553

UCSF-H5664-22834-04A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)