Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: genistein
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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). | Dietary Supplement: genistein<br>* Given orally<br>Procedure: conventional surgery<br>* Patients undergo surgery<br>|
| Experimental: Group B<br>Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months. | Dietary Supplement: genistein<br>* Given orally<br>Procedure: conventional surgery<br>* Patients undergo surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | At surgery & monthly thereafter during treatment (3 mos) | 
| Decrease in prostate-specific antigen-positive cells |  | At time of surgery | 
| Alteration in cell morphology |  | At time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage II prostate cancer