Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT02176902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-19', 'releaseDate': '2025-05-02'}], 'estimatedResultsFirstSubmitDate': '2025-05-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ki-67 index', 'timeFrame': '1 year', 'description': 'The primary statistical analysis will be to compare the Ki67 index between the two intervention arms using a negative binomial mixed effects model'}], 'secondaryOutcomes': [{'measure': 'Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer)', 'timeFrame': '1 year', 'description': 'Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression).'}, {'measure': 'Serum PSA', 'timeFrame': 'Up to 1 year', 'description': 'Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression).'}, {'measure': 'Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)', 'timeFrame': 'Up to 15 years', 'description': 'Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression).'}, {'measure': 'Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)', 'timeFrame': 'Up to 1 year', 'description': 'Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression). Whether the omega-6/omega-3 ratio provides additional predictive information beyond group will be assessed by investigating whether it correlates with Ki-67 within each group.'}, {'measure': 'Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score', 'timeFrame': 'Up to 1 year', 'description': 'Linear regression will be used to correlate PBMC and biopsy GPR120 gene and protein expression to 1-year Ki-67 index and Decipher score . GPR120 gene and protein expression will be added to the linear regression for Ki-67 constructed with group and clinical/demographic covariates.'}, {'measure': 'Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count', 'timeFrame': 'Up to 1 year', 'description': 'Analysis of subject compliance to dietary regimen'}, {'measure': 'Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0', 'timeFrame': 'Up to 1 year', 'description': 'Measure of adverse events incidence'}, {'measure': 'Sample storage for future research', 'timeFrame': 'Up to 1 year', 'description': 'Urine, plasma and flash frozen prostate tissue will be stored for future research evaluating the effects of a LF/FO diet on prostate cancer progression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adenocarcinoma of the Prostate', 'Stage I Prostate Cancer', 'Stage IIA Prostate Cancer', 'Stage IIB Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '39671538', 'type': 'DERIVED', 'citation': 'Aronson 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine if a 1-year low omega-6, high omega-3 fat diet combined with fish oil results in decreased prostate cancer Ki-67 index as compared to a control group in men on active surveillance.\n\nSECONDARY OBJECTIVES:\n\nI. Evaluate the effect of a low-fat (LF)/fish oil (FO) intervention on prostate biopsy tissue markers of progression, prostate biopsy pathologic features (Gleason grade, tumor volume ), prostate-specific antigen (PSA), and long-term clinical outcomes (clinical progression, prostate cancer therapies).\n\nII. Evaluate potential surrogate biomarkers of proliferation (red blood cell \\[RBC\\] membrane fatty acid analyses, ex-vivo bioassay).\n\nIII. Determine if a correlation exists between free fatty acid receptor 4 (GPR120) levels and progression markers in response to the LF/FO intervention.\n\nIV. Evaluate effect of the intervention on the National Comprehension Cancer Network (NCCN) risk group V. Evaluate compliance with a 1-year + 2 year extension LF/FO intervention. VI. Evaluate safety of a 1-year + 2-year extension LF/FO intervention.\n\nOUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive no intervention.\n\nARM II: Patients receive dietary counseling with a research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a high omega-3, low omega-6 diet comprising 30% kilocalories (Kcal) from fat, 15% Kcal from protein, and 65% Kcal from carbohydrates for 1 year. Patients also receive 4 fish oil capsules per day orally (PO) for 1 year.\n\nAfter completion of study, patients are followed up yearly for 15 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients sign the informed consent\n* Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate\n* Patient elects to undergo active surveillance\n* Clinical stage T2c or less\n* Gleason grade 3+4 or less\n* PSA \\< 25\n* Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit\n* Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study\n* If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study\n\nExclusion Criteria:\n\n* Diagnostic prostate biopsy with only 1 core with cancer and \\< 5% of tissue from that core involved with cancer\n* Patient has taken finasteride or dutasteride during the prior year\n* Patient has taken fish oil during the prior 3 months\n* Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)\n* Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year\n* Patient has allergy to fish'}, 'identificationModule': {'nctId': 'NCT02176902', 'briefTitle': 'Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '13-000432'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01257', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '13-000432', 'type': 'OTHER', 'domain': 'Jonsson Comprehensive Cancer Center'}, {'id': 'P50CA092131', 'link': 'https://reporter.nih.gov/quickSearch/P50CA092131', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'behavioral dietary intervention', 'type': 'BEHAVIORAL', 'description': 'Receive dietary counseling', 'armGroupLabels': ['Arm II (fish oil)']}, {'name': 'behavioral dietary intervention', 'type': 'BEHAVIORAL', 'description': 'Receive guidelines for low-fat diet', 'armGroupLabels': ['Arm II (fish oil)']}, {'name': 'omega-3 fatty acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['fish oil', 'n-3 fatty acid', 'O3FA'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (fish oil)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm II (fish oil)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'William Aronson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Pharmavite LLC', 'class': 'INDUSTRY'}, {'name': 'Seafood Industry Research Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-05-02', 'type': 'RELEASE'}, {'date': '2025-05-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jonsson Comprehensive Cancer Center'}}}}