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Diet and PSA Levels in Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00003367   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
April 1998
 
 
 
Complete list of historical versions of study NCT00003367 on ClinicalTrials.gov Archive Site
 
 
 
Diet and PSA Levels in Patients With Prostate Cancer
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

RATIONALE: The amount of fat, fiber, soy, fruits, vegetables, vitamin E, and green tea in the diet may affect androgen metabolism in men. This may affect PSA level in patients with prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two diets, differing in fat, fiber, soy, fruit, vegetable, vitamin E, and green tea content, in affecting PSA level 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.

Phase III
Interventional
Treatment, Randomized
Prostate Cancer
  • Dietary Supplement: green tea
  • Dietary Supplement: soy protein isolate
  • Dietary Supplement: vitamin E
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
154
 
 

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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003367
 
CDR0000066354, MSKCC-98014, NCI-G98-1445
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Moshe Shike, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP