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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00058266 |
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Date of registration:
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07/04/2003 |
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Primary sponsor: |
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Public title:
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Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
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Scientific title:
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A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans) |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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36 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00058266 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Raymond C. Bergan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Robert H. Lurie Cancer Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Dietary Supplement: genistein
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Procedure: conventional surgery
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Primary Outcome(s)
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Alteration in cell morphology
[Time Frame: At time of surgery]
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Decrease in prostate-specific antigen-positive cells
[Time Frame: At time of surgery]
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Toxicity
[Time Frame: At surgery & monthly thereafter during treatment (3 mos)]
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Secondary ID(s)
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NU 00U7
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NU-00U7
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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