Genistein in Treating Patients With Prostate Cancer

Phase 2

Terminated

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

Interventions: Other: placebo
Dietary Supplement: genistein
Procedure: therapeutic conventional surgery

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm II	therapeutic conventional surgery	Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
Arm II	placebo	Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
Arm I	therapeutic conventional surgery	Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
Arm I	genistein	Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Primary Outcome Measures

Name	Time	Method
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs	At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue	At baseline and at time of surgery	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.
Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy	At baseline, 1 and 12 months after surgery	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.
Measurement of PSA in Serum and Plasma by Nanotechnology	At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery	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.