Genistein in Treating Patients With Prostate Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer	Dietary Supplement: genistein; Other: placebo; Procedure: therapeutic conventional surgery	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
Study Start Date :	May 2010
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	May 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: PLCB Procedure: therapeutic conventional surgery; Radical prostatectomy for treatment of prostate cancer

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Determine whether genistein will decrease number of circulating prostate cells (CPCs) in the blood as determined by qRT-PCR for PSA on RNA extracted from PBMNCs [ Time Frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery ]
   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.

Secondary Outcome Measures :

1. Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy [ Time Frame: At baseline, 1 and 12 months after surgery ]
   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.
2. Measure the effect of genistein on select gene and protein expressions in prostate tissue [ Time Frame: At baseline and at time of surgery ]
   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.
3. Measurement of PSA in serum and plasma by nanotechnology [ Time Frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

Principal Investigator:	William Catalona	Northwestern University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Northwestern University
ClinicalTrials.gov Identifier:	NCT01126879 History of Changes
Other Study ID Numbers:	NCI 09U2; NCI-2010-00941; STU00019487 ( Other Identifier: Northwestern University IRB ); P50CA090386 ( U.S. NIH Grant/Contract )
First Posted:	May 20, 2010
Last Update Posted:	December 13, 2017
Last Verified:	December 2017

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Prostatic Neoplasms; Adenocarcinoma; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Genistein	Anticarcinogenic Agents; Protective Agents; Physiological Effects of Drugs; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Phytoestrogens; Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists