Clinical trial · Interventional
Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer
A Phase II Randomized, Open-Label, Two-Arm Study of a Low Omega-6, High Omega-3 Fat Diet Combined With Fish Oil vs. a Control Group in Men on Active Surveillance for Prostate Cancer
NCT02176902CI-TRIAL-00085711active not recruitingN/AClinicalTrials.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)
This randomized phase II trial will evaluate if a low omega-6, high omega-3 fat diet combined with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| omega-3 fatty acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm I (control)
- description
- Patients receive no intervention.
- type
- EXPERIMENTAL
- label
- Arm II (fish oil)
- description
- Patients receive dietary counseling with research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low omega-6, high omega-3 fat diet combined with fish oil. Patients also receive 4 fish oil capsules per day PO for 1 year.
- interventionNames
- Behavioral: behavioral dietary intervention
- Dietary Supplement: omega-3 fatty acid
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Ki-67 index
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients sign the informed consent * Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate * Patient elects to undergo active surveillance * Clinical stage T2c or less * Gleason grade 3+4 or less * PSA \< 25 * Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit * Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study * If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study Exclusion Criteria: * Diagnostic prostate biopsy with only 1 core with cancer and \< 5% of tissue from that core involved with cancer * Patient has taken finasteride or dutasteride during the prior year * Patient has taken fish oil during the prior 3 months * Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy) * Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year * Patient has allergy to fish
References
Publications (1)
- DERIVEDAronson WJ, Grogan T, Liang P, Jardack P, Liddell AR, Perez C, Elashoff D, Said J, Cohen P, Marks LS, Henning SM. High Omega-3, Low Omega-6 Diet With Fish Oil for Men With Prostate Cancer on Active Surveillance: The CAPFISH-3 Randomized Clinical Trial. J Clin Oncol. 2025 Mar;43(7):800-809. doi: 10.1200/JCO.24.00608. Epub 2024 Dec 13. PMID 39671538