An interventional study of lycopene supplement and fish oil supplement in Prostate Cancer, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2016-01-01.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 84 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate meeting the following criteria:
Gleason score ≤ 6 with no pattern 4 or 5 histology
Must have had an extended pattern biopsy (defined as 8+ cores) within the past 2 years
No more than 33% of biopsy cores positive
Must have 3 serum prostate-specific antigen (PSA) level readings taken ≥ 2 weeks apart over the past year
PSA ≤ 10.0 ng/mL
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
Two 15mg lycopene capsules daily for 3 months.
Dietary Supplement: lycopene supplement
1g fish oil capsule daily for 3 months.
Dietary Supplement: fish oil supplement
placebos for lycopene and fish oil.
Other: Placebo
placebos for lycopene and fish oil.
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.
Time frame: baseline through 3 month
Potentially eligible men identified at Urologic Oncology clinic at Helen Diller Family Comprehensive Cancer Center San Francisco starting in 2003.
| Milestone | Lycopene Supplement | Fish Oil Supplement | Placebo |
|---|---|---|---|
| Started | 29 | 27 | 28 |
| Completed | 22 | 21 | 26 |
| Not completed | 7 | 6 | 2 |
| Withdrew: Insufficient rna quality | 7 | 6 | 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.
| fold change | Lycopene Supplement | Fish Oil Supplement | Placebo |
|---|---|---|---|
| IGF-1 | 0.05 ± 1.32 | NA ± NA | 0.02 ± 1.22 |
| COX-2 | NA ± NA | 0.39 ± 1.98 | 0.40 ± 2.19 |
| IGF-1R | 0.20 ± 3.00 | NA ± NA | 0.74 ± 2.86 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | 0/84 (0%) | 0/84 (0%) |
| Age, Continuous(years) | Lycopene Supplement | Fish Oil Supplement | Placebo | Total |
|---|---|---|---|---|
| Mean | 61 ± 7 | 62 ± 8 | 59 ± 8 | 61 ± 8 |
| Sex: Female, Male(Participants) | Lycopene Supplement | Fish Oil Supplement | Placebo | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 29 | 27 | 28 | 84 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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