Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

April 3, 2013 updated by: Barbara Ann Karmanos Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Oxidative DNA damage at 3 and 6 months

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 20, 2005

First Submitted That Met QC Criteria

October 20, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000446088
  • P30CA022453 (U.S. NIH Grant/Contract)
  • WSU-D-2325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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