Prostate Cancer Clinical Trial
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
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.
Full 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 Criteria
DISEASE CHARACTERISTICS:
Diagnosis of localized prostate cancer
Diagnosed within the past 6 months
T1 or T2 disease
Gleason score 5-8
Prostate-specific antigen no greater than 20 ng/mL
Radical prostatectomy planned
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-1
Life expectancy
More than 2 years
Hematopoietic
Hemoglobin greater than 9.0 g/dL
Platelet count greater than 100,000/mm^3
Absolute neutrophil count greater than 1,000/mm^3
Hepatic
SGPT and SGOT less than 3 times normal
Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
Renal
Creatinine less than 2.0 mg/dL
Cardiovascular
No venous thrombosis within the past year
Other
Patients must use effective barrier contraception
No other medical condition that would preclude study therapy
No known soy intolerance
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
No concurrent hormonal therapy for prostate cancer
Radiotherapy
Not specified
Surgery
See Disease Characteristics
Other
No concurrent soy supplements
No concurrent foods high in genistein
No concurrent active therapy for neoplastic disorders
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There are 4 Locations for this study
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Evanston Illinois, 60201, United States
Harvey Illinois, 60426, United States
Seattle Washington, 98195, United States
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