| Phase II Randomized Study of Soy Isoflavones Before Radical Prostatectomy in Patients With Stage I or II Adenocarcinoma of the Prostate
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
Basic Trial Information
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Protocol IDs
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Phase II
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Prevention, Treatment
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Closed
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18 and over
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NCI
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WSU-C-2418
NCT00078923
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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.
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
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 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., Centrum™) allowed
- No concurrent herbs
- No concurrent soy foods
- No other concurrent isoflavone supplements
- No other concurrent antineoplastic agents
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic - ALT and AST less than 2 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2 times ULN
Renal Other - Fertile patients must use effective barrier contraception
- Medically cleared for surgery
- No concurrent thyroid disease
Expected Enrollment A total of 100 patients (25 per treatment arm) will be accrued for this study within 12.5 months. Outcomes Primary Outcome(s)Oxidative DNA damage as measured by 5-hydroxymethyluridine level at 3 weeks
Lipid oxidation as measured by 8-isoprostane level at 3 weeks
Secondary Outcome(s)Tumor size, grade, and extension at 3 weeks
Prostate-specific antigen and prostatic
intraepithelial neoplasia grade at 3 weeks
Biomarkers of cell growth, differentiation, and apoptosis at 3 weeks
Toxicity as measured by number and grade of adverse events at 3 weeks
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 2-6 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.
Trial Contact Information
Trial Lead Organizations Barbara Ann Karmanos Cancer Institute | | | | Omer Kucuk, MD, Principal investigator | | | |
| Registry Information | | | Official Title | | Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy | | | Trial Start Date | | 2003-06-27 | | | Registered in ClinicalTrials.gov | | NCT00078923 | | | Date Submitted to PDQ | | 2004-01-14 | | | Information Last Verified | | 2006-12-12 | | | NCI Grant/Contract Number | | CN85083 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
