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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lycopene supplement
fish oil supplement
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

lycopene supplement

fish oil supplement

placebo

Arm Description

Two 15mg lycopene capsules daily for 3 months.

1g fish oil capsule daily for 3 months.

placebos for lycopene and fish oil.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2006
Last Updated
December 2, 2015
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00402285
Brief Title
Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
Official Title
The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lycopene supplement
Arm Type
Active Comparator
Arm Description
Two 15mg lycopene capsules daily for 3 months.
Arm Title
fish oil supplement
Arm Type
Active Comparator
Arm Description
1g fish oil capsule daily for 3 months.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebos for lycopene and fish oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
lycopene supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil supplement
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebos for lycopene and fish oil.
Primary Outcome Measure Information:
Title
Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2
Description
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.
Time Frame
baseline through 3 month

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R. Carroll, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21912659
Citation
Magbanua MJ, Roy R, Sosa EV, Weinberg V, Federman S, Mattie MD, Hughes-Fulford M, Simko J, Shinohara K, Haqq CM, Carroll PR, Chan JM. Gene expression and biological pathways in tissue of men with prostate cancer in a randomized clinical trial of lycopene and fish oil supplementation. PLoS One. 2011;6(9):e24004. doi: 10.1371/journal.pone.0024004. Epub 2011 Sep 1.
Results Reference
result
PubMed Identifier
24504435
Citation
Magbanua MJ, Richman EL, Sosa EV, Jones LW, Simko J, Shinohara K, Haqq CM, Carroll PR, Chan JM. Physical activity and prostate gene expression in men with low-risk prostate cancer. Cancer Causes Control. 2014 Apr;25(4):515-23. doi: 10.1007/s10552-014-0354-x. Epub 2014 Feb 7.
Results Reference
derived

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

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