Genistein in Treating Patients With Prostate Cancer

Northwestern University

Status and phase: Terminated; Phase 2

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

Treatments: Other: placebo; Dietary Supplement: genistein; Procedure: therapeutic conventional surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01126879

STU00019487 (Other Identifier)

NCI-2010-00941

P50CA090386 (U.S. NIH Grant/Contract)

NCI 09U2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Treatment:

Procedure: therapeutic conventional surgery

Dietary Supplement: genistein

Arm II

Placebo Comparator group

Description:

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Treatment:

Procedure: therapeutic conventional surgery

Other: placebo