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Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy Clinical research trials and Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy. Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy clinical trial. Participants typically obtain the most effective healthcare available for their Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy  Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
For Condition: stage 2 prostate cancer,stage 1 prostate cancer
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Randomizedphase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
Details: OBJECTIVES: - Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy. - Determine the decrease, if any, of PSA-positive cells in the operative field of patients treated with this drug. - Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: 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). - Arm II: 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 arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of localized prostate cancer - Diagnosed within the past 6 months - T1 or T2 disease - Gleason score 5-8 - PSA 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RaymondBergan, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Raymond Bergan 312-908-5284
Silver Cross Hospital *Recruiting*
Joliet, Illinois, 60432
United States
Recruiting Lawrence Schilder 815-740-1400
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Daniel Shevrin 847-570-2515
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Mark Kozloff 708-333-2300
Additional Information:
Study ID Numbers: CDR0000287200; NU-00U7
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058266
Other Stage 2 Prostate Cancer Studies:
1. Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
2. Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
3. Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
4. Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
5. Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Illinois Clinical Trials
Other Harvey Clinical Trials
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
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