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Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00243048
First received: October 20, 2005
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Dietary Supplement: soy protein isolate
Radiation: radiation therapy
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Oxidative DNA damage at 3 and 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: May 2002
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243048

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Omer Kucuk, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00243048     History of Changes
Other Study ID Numbers: CDR0000446088, P30CA022453, WSU-D-2325
Study First Received: October 20, 2005
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013