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 2016
Estimated Primary Completion Date:	May 2015 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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:	June 2, 2014
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 26, 2015