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The Effect of a Low Fat Diet, High in Soy, Fruits, Vegetables, Green Tea, Vitamin E and Fiber on the PSA in Patients With Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

The Effect of a Low Fat Diet, High in Soy, Fruits, Vegetables, Green Tea, Vitamin E and Fiber on the PSA in Patients With Prostate Cancer


OBJECTIVES: I. Determine the effects of 2 dietary regimens on levels of prostate-specific
antigen (PSA) in patients with prostate cancer. II. Determine the compliance of these
patients with the dietary regimen. III. Evaluate the effects of the dietary regimen on
quality of life in these patients. IV. Evaluate the effects of the dietary regimen on PSA
anxiety in these patients. V. Evaluate the effects of the dietary regimen on obesity, high
blood pressure, and serum cholesterol in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to previous treatment
(prostatectomy vs radiotherapy) and prostate-specific antigen (PSA) level (less than 5 mg/mL
vs 5 or greater mg/mL). All patients complete quality of life, dietary, and other
questionnaires before, during, and at the conclusion of the study. Patients are randomized
to one of two dietary intervention regimens: Arm I (Intensive Nutritional Intervention):
Patients are assigned to follow a low fat, high fiber diet that is also high in soy, fruits
and vegetables, green tea, and vitamin E. Patients meet with a nutritionist for nutrition
education and dietary counseling weekly for 8 weeks, then every 2 weeks for 2 months, and
then monthly for 14 months. Sessions include dietary counseling, meal planning, and
instruction in skills necessary to maintain dietary lifestyle changes. Patients record their
dietary intake on a regular basis. Arm II (General Nutritional Instruction): Patients are
assigned to follow dietary guidelines established by the National Cancer Institute. Patients
meet with a nutritionist for dietary counseling and monitoring every 2 months for 18 months.
Patients on both arms have PSA levels tested before the study, 1 and 3 months into the
study, and then every 3 months thereafter for up to 18 months.

PROJECTED ACCRUAL: A total of 154 patients will be accrued for this study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate with
either: Two increases in prostate-specific antigen (PSA) levels with a minimal 30%
increase in range of values following either prostate surgery (prostatectomy) or radiation
therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3 times
upper limit of normal (ULN) Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance
greater than 40 mL/min Cardiovascular: No significant heart disease (New York Heart
Association class III or IV) Pulmonary: No severe debilitating pulmonary disease Other: No
narcotic dependent pain No extreme dietary patterns (such as a macrobiotic diet) No
baseline diet having fewer than 25% calories from fat No history of second malignancy
within past 5 years except nonmelanomatous skin cancer No insulin-dependent diabetes No
infection requiring antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: At least 4 weeks since hormone therapy Radiotherapy: At least 4 weeks
since radiotherapy Surgery: Prior prostatectomy allowed Other: Recovered from toxic
effects of any prior therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Moshe Shike, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-014

NCT ID:

NCT00003367

Start Date:

April 1998

Completion Date:

December 2002

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
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021