Genistein in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs). SECONDARY OBJECTIVES: I. Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy. II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay. III. Measure the effect of genistein on gene and protein expression in prostate tissue by qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy. ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy. All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months following the start of therapy. After completion of study treatment, patients are followed at 1, 6, and 12 months.

Official Title
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Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells

Conditions
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Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: genistein
* Other: placebo
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA >= 10, Gleason score >= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review ECOG performance status 0-1 Hemoglobin > 9.0gm/dl Platelets >= 100 K/uL ANC > 1000/uL AST (SGOT)/ALT (SGPT) < 3X upper limit of normal Creatinine < 2.0 mg/dl Total bilirubin < 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis) Participants must agree not to take soy supplements Ability to understand and the willingness to sign a written informed consent document Willingness to take study agent for at least 2 weeks prior to radical prostatectomy Exclusion History of venous thrombosis within past year Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer) Participants may not be receiving any other investigational agents Known soy intolerance Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy. | Dietary Supplement: genistein<br>* Given orally<br>* Other names: sophoricol;Procedure: therapeutic conventional surgery<br>* Radical prostatectomy for treatment of prostate cancer<br>|
| Placebo Comparator: Arm II<br>Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy. | Other: placebo<br>* Given orally<br>* Other names: PLCB;Procedure: therapeutic conventional surgery<br>* Radical prostatectomy for treatment of prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs | Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery. | At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy | Blood will be drawn to analyze the natural history of circulating prostate cells (CPCs) in a cohort of subjects at baseline and 1 and 12 months after surgery. | At baseline, 1 and 12 months after surgery | 
| Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue | At baseline and time of surgery, tissue will be collected to measure the effect of genistein on select gene and protein expressions in prostate tissue. | At baseline and at time of surgery | 
| Measurement of PSA in Serum and Plasma by Nanotechnology | Blood will be collected to measure PSA in serum and plasma by nanotechnology at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery. | At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery |