Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diet and PSA Levels in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003367
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: green tea
Dietary Supplement: soy protein isolate
Dietary Supplement: vitamin E
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 154
Study Start Date: April 1998
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003367

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Moshe Shike, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003367     History of Changes
Other Study ID Numbers: 98-014, CDR0000066354, NCI-G98-1445
Study First Received: November 1, 1999
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Vitamin E
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 20, 2014