Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00243048|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : April 5, 2013
RATIONALE: Eating a diet high in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of prostate cancer cells and prevent further development of prostate cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving isoflavones together with radiation therapy may be an effective treatment for prostate cancer.
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: soy protein isolate Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Official Title:||Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2007|
- Oxidative DNA damage at 3 and 6 months
- Quality of life as measured by questionnaire at 3 and 6 months
- Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months
- Response as measured by prostate-specific antigen and clinical assessment at 3 and 6 months
- Isoflavone serum level at 3 and 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243048
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Omer Kucuk, MD||Barbara Ann Karmanos Cancer Institute|