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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00402285
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : May 16, 2013
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: lycopene supplement Dietary Supplement: fish oil supplement Other: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
Study Start Date : April 2003
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: lycopene supplement
Two 15mg lycopene capsules daily for 3 months.
 Dietary Supplement: lycopene supplement
Active Comparator: fish oil supplement
1g fish oil capsule daily for 3 months.
 Dietary Supplement: fish oil supplement
Placebo Comparator: placebo
placebos for lycopene and fish oil.
 Other: Placebo
placebos for lycopene and fish oil.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402285


Locations
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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Study Chair: Peter R. Carroll, MD University of California, San Francisco
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00402285    
Other Study ID Numbers: CDR0000505501
UCSF-03553
UCSF-H5664-22834-04A
First Posted: November 22, 2006    Key Record Dates
Results First Posted: May 16, 2013
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by University of California, San Francisco:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Lycopene
Anti-Inflammatory Agents
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents