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Home > "D" Clinical Trials Conditions > Diet and PSA Levels in Patients With Prostate Cancer  Diet and PSA Levels in Patients With Prostate Cancer
Diet and PSA Levels in Patients With Prostate Cancer
For Condition: stage 1 prostate cancer,stage 2 prostate cancer,prevention of prostate cancer,stage 3 prostate cancer,recurrent prostate cancer,adenocarcinoma of the prostate,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MosheShike, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000066354; MSKCC-98014,NCI-G98-1445
Study Start Date: April 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003367
Other Stage 2 Prostate Cancer Studies:
1. Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
2. Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
3. Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer
4. DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
5. Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
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Diet and PSA Levels in Patients With Prostate Cancer
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