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Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer Clinical research trials and Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer. Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer  Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer
Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer
For Condition: stage 2 prostate cancer,stage 1 prostate cancer
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: 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: Randomized clinical trial to study the effectiveness of isoflavones in preventing further development of cancer in patients who have stage I or stage II prostate cancer.
Details: OBJECTIVES: - Determine the effectiveness of isoflavones in producing a change in risk parameters, such as decrease in free testosterone, increase in sex-hormone-binding globulin and estradiol, and decrease in tumor progression and volume, as measured by decreasing prostate-specific antigen in patients with stage I or II prostate cancer. 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. - Arm I: Patients receive oral isoflavones twice daily and an oral multivitamin once daily for 12 weeks. - Arm II: Patients receive oral placebo twice daily and an oral multivitamin once daily for 12 weeks. PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 50 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage I or II prostate cancer - Gleason score 2-6* NOTE: *Patients with a Gleason primary pattern 4 (4 + 1 or 4 + 2) are ineligible PATIENT CHARACTERISTICS: Age: - 50 to 80 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No known history of hepatic disease Renal: - No known history of renal disease Other: - Close to ideal body weight (body mass index no greater than 32 kg/m^2) - No known history of thyroid disease - No allergy to study agent - No other prior malignancy except nonmelanoma skin cancer - No evidence of prostatitis or urinary tract infection - Fertile patients must use effective contraception - Omnivorous diet (no vegan or vegetarian diets) PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior or concurrent biologic therapy for prostate cancer Chemotherapy: - No prior or concurrent chemotherapy for prostate cancer Endocrine therapy: - No prior or concurrent endocrine therapy for prostate cancer - No concurrent thyroid hormone replacement medications Radiotherapy: - No prior or concurrent radiotherapy for prostate cancer Surgery: - No concurrent surgery Other: - At least 30 days since prior antibiotics - At least 30 days since prior ingestion of a diet high in soy products - No other prior or concurrent therapy for prostate cancer - No concurrent diet high in soy products - No concurrent nutritional supplements (e.g., retinoids, beta-carotene, and isoflavones)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
N.B.Kumar, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Cancer Care and Research Pavilion at St. Joseph's/Candler *Recruiting*
Savannah, Georgia, 31405-6015
United States
Recruiting Mark Taylor 912-354-6187
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting N.B. Kumar 813-903-6885
Urology Associates of Pinnellas County *Recruiting*
Clearwater, Florida, 33756
United States
Recruiting Craig Barkley 727-441-1508
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Additional Information:
Study ID Numbers: CDR0000069097; MCC-0002,NCI-4031,NCI-P01-0195
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027950
Other Stage 2 Prostate Cancer Studies:
1. Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
2. Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
3. Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
4. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
5. Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer
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