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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027950 |
Purpose
RATIONALE: Soy isoflavones may reduce the risk of some types of cancer. It is not yet known if isoflavones are effective in preventing the development of prostate cancer.
PURPOSE: This randomized phase III trial is studying the effectiveness of isoflavones in preventing further development of cancer in patients who have stage I or stage II prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: multivitamin Dietary Supplement: soy isoflavones |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Active Control |
| Official Title: | The Specific Role of Isoflavones in Reducing Prostate Cancer Risk |
| Estimated Enrollment: | 148 |
| Study Start Date: | October 2001 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to Gleason score (2-4 vs 5-6). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage I or II prostate cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Arizona | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | |
| Savannah, Georgia, United States, 31405-6015 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Study Chair: | Nagi B. Kumar, PhD, RD, FADA | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Study ID Numbers: | CDR0000069097, MCC-0002, NCI-4031, NCI-P01-0195 |
| Study First Received: | December 7, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027950 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage II prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |