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NCT Number: NCT00243048

Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soy protein isolate

Dietary Supplement

radiation therapy

Radiation

Primary outcomes

  1. Oxidative DNA damage at 3 and 6 months

Secondary outcomes

  1. Quality of life as measured by questionnaire at 3 and 6 months

  2. Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months

  3. Response as measured by prostate-specific antigen and clinical assessment at 3 and 6 months

  4. Isoflavone serum level at 3 and 6 months

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Oct 21, 2005
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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