|
Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer Clinical research trials and Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer. Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer  Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Isoflavones Compared With Lycopene Before Surgery in Treating 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: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may prevent the development of cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
Details: OBJECTIVES: - Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer. - Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients. - Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients. - Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients. - Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment arms. - Arms I-III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. - Arms IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. - Arm VII: Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 45 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed localized prostate cancer - Stage I or II - Scheduled prostatectomy between 4-6 weeks after initial biopsy PATIENT CHARACTERISTICS: Age: - 45 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: - No known history of thyroid disease - Body mass index no greater than 32 - Omnivorous diet - No known allergy to study supplements - No evidence of prostatitis or urinary tract infection - No other prior malignancy except nonmelanoma skin cancer - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No concurrent thyroid hormone replacement medications Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - At least 30 days since prior antibiotics - At least 30 days since prior diet high in soy and/or lycopene products (e.g., greater than 40 mg soy/day and/or greater than 15 mg lycopene/day) - No other concurrent nutritional supplements, including modular supplements with other carotenoids and isoflavones - No prior or concurrent therapy for prostate cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
N.B.Kumar, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Ralph Levitt 701-234-7592
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-239-2413
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Cancer Care and Research Pavilion at St. Joseph's/Candler *Recruiting*
Savannah, Georgia, 31405-6015
United States
Recruiting Mark Taylor 912-354-6187
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting N.B. Kumar 813-903-6885
Additional Information:
Study ID Numbers: CDR0000069265; NCI-3811,NCI-P02-0216,MCC-0105
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042731
Other Stage 2 Prostate Cancer Studies:
1. Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
2. Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
3. Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
4. Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
5. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Georgia Clinical Trials
Other Savannah Clinical Trials
Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
|
|
|
|
|
|
|
|
