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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Oxidative DNA damage at 3 and 6 months

Safety Issue:

No

Principal Investigator

Omer Kucuk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000446088

NCT ID:

NCT00243048

Start Date:

May 2002

Completion Date:

October 2007

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201