Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

NCT00243048 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000446088P30CA022453WSU-D-2325
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer

Outcome Measures

Primary Outcomes (1)

• Oxidative DNA damage at 3 and 6 months

Secondary Outcomes (4)

• 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

Interventions

soy protein isolate DIETARY_SUPPLEMENT

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Soybean Proteins; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Therapeutics

Study Officials

• Omer Kucuk, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: May 1, 2002
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2007
• Last Updated: April 5, 2013

Record last verified: 2013-04

Locations

US (1)