genistein in treating patients with prostate cancer

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

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.

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.

Eligibility criteria:
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