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Effects of a Low Fat Diet on Serum Factors and Prostate Cancer


Phase 2
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Effects of a Low Fat Diet on Serum Factors and Prostate Cancer


OBJECTIVES:

- Compare the inhibition of growth of human prostate cancer cell lines by serum from
patients with prostate cancer before and after being fed a low fat, high fiber diet.

- Determine the underlying mechanism through which a low fat, high fiber diet affects the
growth of prostate cancer cell lines.

- Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer
cell lines through androgen-dependent and/or androgen- independent mechanisms in these
patients.

- Determine the growth factors, hormones, and/or binding proteins that may be responsible
for affecting the growth of prostate cancer cell lines in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.

- Arm II: Patients receive a control diet containing the standard amounts of fat and
fiber.

PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within
6 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of adenocarcinoma of the prostate

- Previously untreated and on watchful waiting

- Medically able to receive dietary intervention

PATIENT CHARACTERISTICS:

Age:

- 40 to 80

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Must be willing to travel to UCLA 3 days a week for 4 weeks to obtain specially
prepared foods

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- No concurrent luteinizing hormone-releasing hormone agonists (leuprolide or
goserelin)

- No concurrent androgen-receptor blocking agents (flutamide or bicalutamide)

- No concurrent testosterone

- No concurrent insulin

- No concurrent finasteride

Radiotherapy:

- Not specified

Surgery:

- No prior orchiectomy

Other:

- No concurrent saw palmetto supplement

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

William Aronson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068737

NCT ID:

NCT00020995

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781