Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer
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.
Dietary Supplement: soy protein isolate
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy|
- Oxidative DNA damage at 3 and 6 months [ Designated as safety issue: No ]
- Quality of life as measured by questionnaire at 3 and 6 months [ Designated as safety issue: No ]
- Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months [ Designated as safety issue: Yes ]
- Response as measured by prostate-specific antigen and clinical assessment at 3 and 6 months [ Designated as safety issue: No ]
- Isoflavone serum level at 3 and 6 months [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|