Genistein in Treating Patients With Prostate Cancer - Full Text View

Purpose

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	Intervention	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Genistein

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
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.
Measure the effect of genistein on select gene and protein expressions in prostate tissue [ Time Frame: At baseline and at time of surgery ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	36
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126879

Contacts

Contact: William Catalona, MD	312-695-6124	wcatalona@nmff.org
Contact: study Coordinator	312-695-1301	cancertrials@northwestern.edu

Locations

United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: William Catalona 312-695-6124 wcatalona@nmff.org
Principal Investigator: William Catalona
Sub-Investigator: Timothy Kuzel, MD
Sub-Investigator: Gary MacVicar, MD
Sub-Investigator: Raymond Bergan, MD
Sub-Investigator: Karen Kaul, MD, PhD

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

William Catalona

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University
ClinicalTrials.gov Identifier:	NCT01126879 History of Changes
Other Study ID Numbers:	NCI 09U2, NCI-2010-00941, STU00019487, P50CA090386
Study First Received:	May 18, 2010
Last Updated:	March 19, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Genistein

Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013