Genistein in Treating Patients With Prostate Cancer

Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells

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.

Study Overview

• Status: Terminated
• Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer; Adenocarcinoma of the Prostate
• Intervention / Treatment: Other: placebo; Dietary supplement: genistein; Procedure: therapeutic conventional surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.	Dietary supplement: genistein; Given orally; Other Names: CI 75610; Genestein; genisteol; genisterin; prunetol; sophoricol; Procedure: therapeutic conventional surgery; Radical prostatectomy for treatment of prostate cancer
Placebo Comparator: Arm II; Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.	Other: placebo; Given orally; Other Names: PLCB; Procedure: therapeutic conventional surgery; Radical prostatectomy for treatment of prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William Catalona, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2011
• Primary Completion (Actual): May 9, 2013
• Study Completion (Actual): December 28, 2013

Study Registration Dates

• First Submitted: May 18, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (Estimate): May 20, 2010

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Estrogens, Non-Steroidal; Estrogens; Protein Kinase Inhibitors; Anticarcinogenic Agents; Phytoestrogens; Genistein
• Other Study ID Numbers: NCI 09U2; NCI-2010-00941; STU00019487 (Other Identifier: Northwestern University IRB); P50CA090386 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No