Adenocarcinoma of the ProstateNCT02176902
Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer
A study testing behavioral dietary intervention, omega-3 fatty acid and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Stage I Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer
- What is being tested?
- behavioral dietary intervention, omega-3 fatty acid and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
SECONDARY OBJECTIVES:
- 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).
II. Evaluate potential surrogate biomarkers of proliferation (red blood cell [RBC] membrane fatty acid analyses, ex-vivo bioassay).
III. Determine if a correlation exists between free fatty acid receptor 4 (GPR120) levels and progression markers in response to the LF/FO intervention.
IV. 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.
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive no intervention.
ARM 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.
After completion of study, patients are followed up yearly for 15 years.
- Conditions
- Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Being tested
- behavioral dietary intervention, omega-3 fatty acid, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
Receive dietary counseling
behavioral dietary interventionBehavioural
Receive guidelines for low-fat diet
omega-3 fatty acidDietary supplement
Also called fish oil, n-3 fatty acid, O3FA
Given PO
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (control) | No intervention | Patients receive no intervention. |
| Arm II (fish oil) | Experimental | 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. Receives: Behavioral: behavioral dietary intervention; Dietary Supplement: omega-3 fatty acid; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki-67 index
The primary statistical analysis will be to compare the Ki67 index between the two intervention arms using a negative binomial mixed effects model
Measured: 1 year
Secondary outcomes (8)
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)
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).
Measured: 1 year
Serum PSA
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).
Measured: Up to 1 year
Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)
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).
Measured: Up to 15 years
Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)
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.
Measured: Up to 1 year
Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score
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.
Measured: Up to 1 year
Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count
Analysis of subject compliance to dietary regimen
Measured: Up to 1 year
Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0
Measure of adverse events incidence
Measured: Up to 1 year
Sample storage for future research
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study start1 Nov 2014
- Primary completion19 Apr 2023
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pharmavite LLC, Seafood Industry Research Fund
- Responsible party
- Sponsor
- Investigators
- William Aronson, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176902
- Sponsor's protocol ID
- 13-000432
- Other IDs
- NCI-2014-01257, 13-000432, P50CA092131
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2014
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39671538
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02176902
- Acronym / sponsor ID
- 13-000432
- Conditions
- Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pharmavite LLC, Seafood Industry Research Fund
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
SECONDARY OBJECTIVES:
- 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).
II. Evaluate potential surrogate biomarkers of proliferation (red blood cell [RBC] membrane fatty acid analyses, ex-vivo bioassay).
III. Determine if a correlation exists between free fatty acid receptor 4 (GPR120) levels and progression markers in response to the LF/FO intervention.
IV. 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.
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive no intervention.
ARM 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.
After completion of study, patients are followed up yearly for 15 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (control) | No intervention | –Patients receive no intervention. |
| Arm II (fish oil) | Experimental | Behavioral: behavioral dietary intervention, Dietary Supplement: omega-3 fatty acid, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| behavioral dietary interventionReceive dietary counseling | Behavioural | Arm II (fish oil) |
| behavioral dietary interventionReceive guidelines for low-fat diet | Behavioural | Arm II (fish oil) |
| omega-3 fatty acidAlso: fish oil, n-3 fatty acid, O3FAGiven PO | Dietary supplement | Arm II (fish oil) |
| laboratory biomarker analysisCorrelative studies | Other | Arm II (fish oil) |
Primary outcome
Ki-67 index
Time frame: 1 year
The primary statistical analysis will be to compare the Ki67 index between the two intervention arms using a negative binomial mixed effects model
8 secondary outcomes
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)
Time frame: 1 year
Serum PSA
Time frame: Up to 1 year
Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)
Time frame: Up to 15 years
Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)
Time frame: Up to 1 year
Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score
Time frame: Up to 1 year
Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count
Time frame: Up to 1 year
Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0
Time frame: Up to 1 year
Sample storage for future research
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 39671538Aronson 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.
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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.
William Aronson principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral dietary intervention, omega-3 fatty acid and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Stage I Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2025. 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. 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?
Results are not available in the source record.
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?
Ki-67 index (time frame: 1 year). 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 NCT02176902, which also lists 1 linked publication.
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 10 Feb 2025.