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Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate 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 Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate Clinical research trials and Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate 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 Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate. Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate 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 Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate clinical trial. Subjects frequently obtain the most expert healthcare possible for their Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate 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 > "S" Clinical Trials Conditions > Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate  Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
For Condition: stage 1 prostate cancer,stage 2 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of different regimens of soy isoflavones in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).
Details: OBJECTIVES: - Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy. - Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens. - Determine the potential response, in terms of tumor and prostatic intraepithelial neoplasia grade and volume, extraprostatic extension, and serum prostate-specific antigen level, in patients treated with soy isoflavones and in those treated with placebo. - Determine the safety of soy isoflavone supplementation in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study. Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1 of 4 treatment arms. - Arm I (control group): Patients receive oral placebo once daily. - Arm II: Patients receive oral soy isoflavones and oral placebo once daily. - Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once daily. - Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones once daily. In all arms, treatment continues for 3-4 weeks (depending on the time from study entry to planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical prostatectomy. Patients are followed at 1 week. PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study within 12.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Stage T1c or T2 - Disease confined to the prostate gland - Planning to undergo radical prostatectomy within the next 3-4 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - ALT and AST less than 2 times upper limit of normal (ULN) - Alkaline phosphatase less than 2 times ULN Renal - Not specified Other - Fertile patients must use effective barrier contraception - Medically cleared for surgery - No concurrent thyroid disease PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biological therapy for prostate cancer - No concurrent biological agents Chemotherapy - No prior chemotherapy for prostate cancer - No concurrent chemotherapy Endocrine therapy - No prior hormonal therapy for prostate cancer - No concurrent thyroid hormone replacement medication - No concurrent hormonal therapy Radiotherapy - Not specified Surgery - See Disease Characteristics Other - At least 3 months since prior high-dose nutritional supplements - No concurrent regular use (more than once weekly) of soy products greater than 50 g of soy protein or 50 mg of soy isoflavone - No concurrent high-dose nutritional supplements - Standard-dose single multivitamin tablet (e.g., Centrumâ„¢) allowed - No concurrent herbs - No concurrent soy foods - No other concurrent isoflavone supplements - No other concurrent antineoplastic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OmerKucuk, Principal Investigator, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Omer Kucuk 313-745-2748
Additional Information:
Study ID Numbers: CDR0000353197; WSU-C-2418
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078923
Other Stage 1 Prostate Cancer Studies:
1. Hormone Therapy in Treating Patients Who Have Stage I or Stage II Prostate Cancer
2. Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
3. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
4. Assessing Quality of Life of Patients With Prostate Cancer
5. Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
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