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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Given orally
Patients undergo surgery
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
Toxicity
Time frame: At surgery & monthly thereafter during treatment (3 mos)
Decrease in prostate-specific antigen-positive cells
Time frame: At time of surgery
Alteration in cell morphology
Time frame: At time of surgery
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University of Washington School of Medicine
Seattle, Washington, United States