Clinical trial NCT00243048: Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer
Official title: Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage II prostate cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-21
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate that is localized to the prostate gland
* Must be scheduled to receive curative radiotherapy for prostate cancer
* Not eligible for a higher priority study at the Karmanos Cancer Institute

PATIENT CHARACTERISTICS:

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

Primary outcomes:
measure: Oxidative DNA damage at 3 and 6 months
Secondary outcomes:
measure: Quality of life as measured by questionnaire at 3 and 6 months
measure: Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months
measure: Response as measured by prostate-specific antigen and clinical assessment at 3 and 6 months
measure: Isoflavone serum level at 3 and 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Omer Kucuk, MD
role: STUDY_CHAIR
References: