Genistein 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.

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