N/A
Completed N=84
Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
Source: ClinicalTrials.gov NCT00402285 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2 — 0.05; NA; 0.02; NA fold change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2 |
0.05; NA; 0.02; NA; 0.39; 0.40 | — |
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 ( 7 days duration
- No concurrent NSAIDs, COX-2 inhibitors, or aspirin
Data sourced from ClinicalTrials.gov (NCT00402285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.