|
Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. 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 medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, 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 for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally 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. Participants frequently get the best healthcare available for their Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
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. Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
2. Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
3. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
4. Combination Chemotherapy in Treating Patients With Advanced 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 Missouri Clinical Trials
Other Springfield Clinical Trials
Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer
|
|
|
|
|
|
|
|
