Spots Global Cancer Trial Database for Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
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Trial Identification
Brief Title: Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
Official Title: A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
Study ID: NCT00058266
Conditions
Study Description
Brief Summary: RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
Detailed Description: OBJECTIVES: * Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy. * Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug. * Determine the quality of life of patients treated with this drug. OUTLINE: Patients receive 1 of 2 treatment regimens. * Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy). * Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months. Quality of life is assessed at baseline and at 1 and 3 months after surgery. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States
University of Washington School of Medicine, Seattle, Washington, United States
Contact Details
Name: Raymond C. Bergan, MD
Affiliation: Robert H. Lurie Cancer Center
Role: STUDY_CHAIR
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