- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00058266
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
Chicago, Illinois, United States, 60611
- Veterans Affairs Medical Center - Lakeside Chicago
-
Evanston, Illinois, United States, 60201-1781
- Evanston Northwestern Healthcare - Evanston Hospital
-
Harvey, Illinois, United States, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
Given orally
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.
|
Given orally
Patients undergo surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity
Time Frame: At surgery & monthly thereafter during treatment (3 mos)
|
At surgery & monthly thereafter during treatment (3 mos)
|
Decrease in prostate-specific antigen-positive cells
Time Frame: At time of surgery
|
At time of surgery
|
Alteration in cell morphology
Time Frame: At time of surgery
|
At time of surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Raymond C. Bergan, MD, Robert H. Lurie Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Estrogens, Non-Steroidal
- Estrogens
- Protein Kinase Inhibitors
- Anticarcinogenic Agents
- Phytoestrogens
- Genistein
Other Study ID Numbers
- NU 00U7
- NU-00U7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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