Genistein in Treating Patients With Prostate Cancer

Phase 2TerminatedNCT01126879

Northwestern University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

genisteinDIETARY_SUPPLEMENT

Given orally

placeboOTHER

Given orally

therapeutic conventional surgeryPROCEDURE

Radical prostatectomy for treatment of prostate cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery

Data from ClinicalTrials.gov

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