Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer
behavioral dietary intervention
+ dietary intervention
+ therapeutic dietary intervention
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: July 28, 2000
Actual date on which the first participant was enrolled.OBJECTIVES: * Determine whether a behavior-based dietary intervention can motivate patients with hormone-refractory prostate cancer to adopt and maintain a dietary pattern that includes < 20% of energy from fat, > 25 g of fiber, and 80 g of soy protein powder. * Compare bioavailable levels of testosterone in patients treated with a behavior-based dietary intervention vs observation only. * Determine whether this dietary intervention decreases or stabilizes a rising serum prostate-specific antigen level in these patients. * Determine whether this dietary intervention improves disease-specific survival, mediated by reduced bioavailable levels of testosterone, in these patients. * Determine the impact of a positive intervention outcome on androgen receptors in patients treated with this dietary intervention. OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms. All patients receive nutritional counseling on a healthy diet. Patients also keep a food diary during study participation. * Arm I (dietary intervention): Patients receive dietary intervention comprising nutritional counseling on a low-fat, high-fiber, soy supplemented diet and behavior-based activities, such as goal-setting, contracting, and stimulus control, once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52. Treatment continues in the absence of disease progression or unacceptable toxicity. * Arm II (observation): Patients undergo observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks. PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.56 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * No small cell component * No histologically confirmed and/or demonstrable metastatic or locally recurrent disease by bone scan, chest x-ray, computed tomography (CT) scan, or transrectal ultrasound * No clinical symptoms within the past 90 days * Documented biochemical failure after radical prostatectomy * Prostate-specific antigen must have initially nadired to an undetectable level (\< 0.1 ng/mL) after prostatectomy AND is currently rising (0.3-40.0 ng/mL) * Serum testosterone \> 100 ng/dL PATIENT CHARACTERISTICS: Age * Any age Performance status * Zubrod 0-1 Life expectancy * At least 1 year Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No known allergic reactions to milk or soy products PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 1 year since prior chemotherapy Endocrine therapy * More than 1 year since prior hormonal therapy Radiotherapy * Not specified Surgery * See Disease Characteristics
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location