Clinical trial · Interventional
Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
NCT00402285CI-TRIAL-00020407completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fish oil supplement | Dietary Supplement | — | UNRESOLVED |
| lycopene supplement | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- lycopene supplement
- description
- Two 15mg lycopene capsules daily for 3 months.
- interventionNames
- Dietary Supplement: lycopene supplement
- type
- ACTIVE_COMPARATOR
- label
- fish oil supplement
- description
- 1g fish oil capsule daily for 3 months.
- interventionNames
- Dietary Supplement: fish oil supplement
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebos for lycopene and fish oil.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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 aspirinReferences
Publications (2)
- RESULTMagbanua 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. PMID 21912659
- DERIVEDMagbanua 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. PMID 24504435