Low-Fat Fish Oil Diet for Prostate Cancer Prevention

Summary

Studies on patterns of how many men get prostate cancer in other countries show that environment contributes to the high incidence of prostate cancer in the United States. Epidemiology studies suggest that this influence may be reduced by the diet of men at risk of getting prostate cancer. Although the exact nature of the effects of diet are not completely known, the amount of fat eaten appears to affect the number of men who get prostate cancer. The type of fat also seems to matter. Eating more of a type of fat called omega-3 polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat comes from fish and is quite different from the type of fat from animals and vegetables (omega-6 fat). Because the exact mechanism of this reduction in prostate cancer risk is not known, no blood test indications, called markers, have been discovered that would show the effect working.

Study doctors designed this study to try to find markers in the blood tests of men who have prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil helps reduce those markers, hence indicating that it helps reduce the cancer in these men. These men will be compared to men with prostate cancer whose diets do not contain the fish-oil fat.

The men chosen will have prostate cancer and be scheduled for operations to have their prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the beginning of the diet. After the 4-to-8-week period, they will have their operations. Their blood will be checked again and a sample of their removed prostate will be examined to tell if the diet had any effect on the cancer and its markers.

Conditions

• Prostate Cancer

Interventions

DIETARY_SUPPLEMENT

Fish Oil

Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.

DIETARY_SUPPLEMENT

Vitamin E supplement

Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.

DIETARY_SUPPLEMENT

Western Diet

Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.

DIETARY_SUPPLEMENT

Low-Fat Diet

Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.

OTHER

Medical Examination

Subjects will have a routine medical exam.

OTHER

Dietary Interview

Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.

OTHER

Blood Draw

40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.

PROCEDURE

Radical Prostatectomy

Subjects will undergo a radical prostatectomy as part of their standard of care.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• William Aronson, MD · UCLA and Western Los Angles VA

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-12-18

Primary Completion

2018-02-12

Completion

2018-02-12

Countries

• United States

Study Locations