Genistein in Treating Patients With Prostate Cancer

NCT ID: NCT01126879

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-03
• Study Completion Date: 2013-12-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

genistein

Intervention Type: DIETARY_SUPPLEMENT

Given orally

therapeutic conventional surgery

Intervention Type: PROCEDURE

Radical prostatectomy for treatment of prostate cancer

Arm II

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

therapeutic conventional surgery

Intervention Type: PROCEDURE

Radical prostatectomy for treatment of prostate cancer

Interventions

genistein

Given orally

Intervention Type: DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type: OTHER

therapeutic conventional surgery

Radical prostatectomy for treatment of prostate cancer

Intervention Type: PROCEDURE

Other Intervention Names

CI 75610; Genestein; genisteol; genisterin; prunetol; sophoricol; PLCB

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Catalona

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2010-00941

Identifier Type: -

Identifier Source: secondary_id

STU00019487

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA090386

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI 09U2

Identifier Type: -

Identifier Source: org_study_id