A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity
Outcome Time Frame:
At surgery & monthly thereafter during treatment (3 mos)
Safety Issue:
Yes
Principal Investigator
Raymond C. Bergan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 00U7
NCT ID:
NCT00058266
Start Date:
December 2002
Completion Date:
September 2009
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage II prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
| University of Washington School of Medicine | Seattle, Washington 98195 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
