Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243048
• Other study ID #: CDR0000446088
• Secondary ID: P30CA022453WSU-D
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2005
• Last updated: April 3, 2013
• Start date: May 2002
• Est. completion date: October 2007

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• soy protein isolate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative DNA damage at 3 and 6 months			No
Secondary	Quality of life as measured by questionnaire at 3 and 6 months			No
Secondary	Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months			Yes
Secondary	Response as measured by prostate-specific antigen and clinical assessment at 3 and 6 months			No
Secondary	Isoflavone serum level at 3 and 6 months			No