Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer
NCT ID: NCT00243048
Last Updated: 2013-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2002-05-31
2007-10-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying the side effects and how well giving isoflavones together with radiation therapy works in treating patients with localized prostate cancer.
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Detailed Description
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* Determine the effect of soy protein isolate (isoflavones) and radiotherapy on the modulation of biomarkers in patients with localized prostate cancer.
* Determine the toxicity of this regimen in these patients.
* Determine the effect of this regimen on the quality of life of these patients.
OUTLINE: This is a randomized, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral soy protein isolate (isoflavones) twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive an oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
In both arms, patients also undergo radiotherapy while receiving isoflavones or placebo.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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soy protein isolate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
Performance status
* 0-3
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No organ function restrictions
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* No prior hormonal therapy
Radiotherapy
* See Disease Characteristics
Other
* No other concurrent micronutrient supplements, herbs, or vitamins except 1 daily multivitamin
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Omer Kucuk, MD
Role: STUDY_CHAIR
Barbara Ann Karmanos Cancer Institute
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Other Identifiers
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WSU-D-2325
Identifier Type: -
Identifier Source: secondary_id
CDR0000446088
Identifier Type: -
Identifier Source: org_study_id
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