Completed

Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer

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What is being tested

behavioral dietary intervention

+ dietary intervention
+ therapeutic dietary intervention
Behavioral
Dietary Supplement
Procedure
Who is being recruted

Urogenital Diseases
+7

+ Genital Diseases
+ Genital Diseases, Male
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2000
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 28, 2000Actual 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.

Official TitleImpact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer 
NCT00082732
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
56 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Prostatic Neoplasms
Urogenital Neoplasms
Male Urogenital Diseases
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.
Treatment Groups
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.

Study 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
Suspended
University of Texas - MD Anderson Cancer CenterHouston, United StatesSee the location
CompletedOne Study Center
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