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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058266 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: genistein Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans) |
Estimated Enrollment: | 88 |
Study Start Date: | December 2002 |
Arms | Assigned Interventions |
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Group A: Experimental
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).
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Drug: genistein
Given orally
Procedure: conventional surgery
Patients undergo surgery
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Group B: Experimental
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
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Drug: genistein
Given orally
Procedure: conventional surgery
Patients undergo surgery
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OBJECTIVES:
OUTLINE: Patients receive 1 of 2 treatment regimens.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of localized prostate cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
Evanston Northwestern Healthcare - Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
Veterans Affairs Medical Center - Lakeside Chicago | |
Chicago, Illinois, United States, 60611 | |
United States, Washington | |
University of Washington School of Medicine | |
Seattle, Washington, United States, 98195 |
Study Chair: | Raymond C. Bergan, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Raymond C. Bergan ) |
Study ID Numbers: | CDR0000287200, NU-00U7 |
Study First Received: | April 7, 2003 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00058266 |
Health Authority: | United States: Federal Government |
stage I prostate cancer stage II prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Genistein |
Anticarcinogenic Agents Estrogens Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Protein Kinase Inhibitors |
Hormones Protective Agents Pharmacologic Actions Neoplasms Neoplasms by Site Estrogens, Non-Steroidal Therapeutic Uses Phytoestrogens |