Prostate CancerNCT00402285
Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
A study testing lycopene supplement and fish oil supplement in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- lycopene supplement and fish oil supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- lycopene supplement, fish oil supplement, Placebo
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lycopene supplementDietary supplement
fish oil supplementDietary supplement
PlaceboOther
placebos for lycopene and fish oil.
| Study group | Role | What they receive |
|---|---|---|
| lycopene supplement | Active comparator | Two 15mg lycopene capsules daily for 3 months. Receives: Dietary Supplement: lycopene supplement |
| fish oil supplement | Active comparator | 1g fish oil capsule daily for 3 months. Receives: Dietary Supplement: fish oil supplement |
| placebo | Placebo comparator | placebos for lycopene and fish oil. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline through 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startApr 2003
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter R. Carroll, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402285
- Sponsor's protocol ID
- CDR0000505501
- Other IDs
- UCSF-03553, UCSF-H5664-22834-04A
- Status last verified
- Dec 2015
- First submitted
- 20 Nov 2006
- Last updated
- 1 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 21912659Magbanua 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.
PubMed 24504435
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
- ClinicalTrials.gov ID
- NCT00402285
- Acronym / sponsor ID
- CDR0000505501
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lycopene supplement | Active comparator | Dietary Supplement: lycopene supplementTwo 15mg lycopene capsules daily for 3 months. |
| fish oil supplement | Active comparator | Dietary Supplement: fish oil supplement1g fish oil capsule daily for 3 months. |
| placebo | Placebo comparator | Other: Placeboplacebos for lycopene and fish oil. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lycopene supplement | Dietary supplement | lycopene supplement |
| fish oil supplement | Dietary supplement | fish oil supplement |
| Placeboplacebos for lycopene and fish oil. | Other | placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21912659Magbanua 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.
- Derived from this study: PubMed 24504435Magbanua 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter R. Carroll, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lycopene supplement and fish oil supplement in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402285, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.