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Low-Fat Diet + Fish Oil for Prostate Cancer

N/A

Waitlist Available

Led By William Aronson

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate

Gleason grade 3+4 or less

Must not have

Patient has taken finasteride or dutasteride during the prior year

Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will see if a low-fat diet with fish oil can help slow down disease progression in prostate cancer patients who are being actively monitored.

Who is the study for?

This trial is for men with prostate cancer who are on active surveillance, have a Gleason grade of 3+4 or less, and a PSA level under 20. They must not consume certain supplements or fish oil capsules during the study and be able to visit UCLA for check-ups. Men who've had prior prostate cancer treatments or take specific medications can't join.

What is being tested?

The trial is testing if a low-fat diet combined with fish oil supplements can slow down prostate cancer progression in patients opting for active surveillance rather than immediate treatment.

What are the potential side effects?

Potential side effects may include changes in digestion due to dietary adjustments and possible reactions to omega-3 fatty acids if there's an unknown allergy to fish products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a prostate biopsy with Dr. Mark using the Artemis and was diagnosed with adenocarcinoma.

Select...

My prostate cancer has a Gleason score of 7 or less.

Select...

My cancer is at an early stage and has not spread widely.

Select...

I am willing to avoid lycopene, green tea, pomegranate supplements, and juice for a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have taken finasteride or dutasteride in the last year.

Select...

I have had treatment for prostate cancer before.

Select...

My prostate cancer was found in just one biopsy core and affects less than 5% of that sample.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ki-67 index

Secondary study objectives

Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count

Malignant Neoplasms

Biological Assay

+5 more

Side effects data

From 2014 Phase 3 trial • 262 Patients • NCT01385137

47%

Arthralgia

20%

Dyspepsia

15%

Diarrhea

10%

Nausea

Joint range of motion decreased

Bloating

Fatigue

Headache

Hot flashes

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (Placebo)

Arm I (Omega-3-fatty Acid)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (fish oil)Experimental Treatment3 Interventions

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.

Group II: Arm I (control)Active Control1 Intervention

Patients receive no intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

behavioral dietary intervention

2000

Completed Phase 1

~750

omega-3 fatty acid

2013