Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy - Full Text View

Sponsor:	Northwestern University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00058266

Purpose

RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: genistein Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)

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:

Toxicity [ Time Frame: At surgery & monthly thereafter during treatment (3 mos) ] [ Designated as safety issue: Yes ]
Decrease in prostate-specific antigen-positive cells [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
Alteration in cell morphology [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	December 2002
Study Completion Date:	September 2009
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).	Dietary Supplement: genistein Given orally Procedure: conventional surgery Patients undergo surgery
Experimental: Group B Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.	Dietary Supplement: genistein Given orally Procedure: conventional surgery Patients undergo surgery

Detailed Description:

OBJECTIVES:

Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.
Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.
Determine the quality of life of patients treated with this drug.

OUTLINE: Patients receive 1 of 2 treatment regimens.

Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.

Quality of life is assessed at baseline and at 1 and 3 months after surgery.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of localized prostate cancer
- Diagnosed within the past 6 months
- T1 or T2 disease
- Gleason score 5-8
- Prostate-specific antigen no greater than 20 ng/mL
Radical prostatectomy planned

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

More than 2 years

Hematopoietic

Hemoglobin greater than 9.0 g/dL
Platelet count greater than 100,000/mm^3
Absolute neutrophil count greater than 1,000/mm^3

Hepatic

SGPT and SGOT less than 3 times normal
Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)

Renal

Creatinine less than 2.0 mg/dL

Cardiovascular

No venous thrombosis within the past year

Other

Patients must use effective barrier contraception
No other medical condition that would preclude study therapy
No known soy intolerance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

No concurrent hormonal therapy for prostate cancer

Radiotherapy

Not specified

Surgery

See Disease Characteristics

Other

No concurrent soy supplements
No concurrent foods high in genistein
No concurrent active therapy for neoplastic disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058266

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

Study Chair:

Raymond C. Bergan, MD

Robert H. Lurie Cancer Center

More Information

No publications provided

Responsible Party:	Raymond C. Bergan, Robert H. Lurie Comprehensive Cancer Center at Northwestern University
ClinicalTrials.gov Identifier:	NCT00058266 History of Changes
Other Study ID Numbers:	NU 00U7, NU-00U7
Study First Received:	April 7, 2003
Last Updated:	May 19, 2011
Health Authority:	United States: Federal Government

Keywords provided by Northwestern University:

stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
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 February 09, 2012