Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
NCT ID: NCT00058266
Last Updated: 2012-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
36 participants
INTERVENTIONAL
2002-12-31
2009-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
genistein
Given orally
conventional surgery
Patients undergo surgery
Group B
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
genistein
Given orally
conventional surgery
Patients undergo surgery
Interventions
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genistein
Given orally
conventional surgery
Patients undergo surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Raymond C. Bergan, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States
University of Washington School of Medicine
Seattle, Washington, United States
Countries
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Other Identifiers
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NU-00U7
Identifier Type: -
Identifier Source: secondary_id
NU 00U7
Identifier Type: -
Identifier Source: org_study_id