Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy

Study Overview
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Brief Summary
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RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate 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.

Detailed Description
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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 groups. PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.

Official Title
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A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: Lycopene
* Dietary Supplement: Multivitamin
* Dietary Supplement: Soy isoflavones


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral isoflavones with multivitamin<br>Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. | Dietary Supplement: Multivitamin<br>* Daily administration as outlined in treatment arm(s)<br>Dietary Supplement: Soy isoflavones<br>* Daily administration as outlined in treatment arm(s)<br>|
| Active Comparator: Oral lycopene with multivitamin<br>Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. | Dietary Supplement: Lycopene<br>* Daily administration as outlined in treatment arm(s)<br>Dietary Supplement: Multivitamin<br>* Daily administration as outlined in treatment arm(s)<br>|
| Active Comparator: Multiple vitamin alone<br>Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. | Dietary Supplement: Multivitamin<br>* Daily administration as outlined in treatment arm(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrences of Treatment Effect on Biomarkers in Each Group | Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrences of Plasma Level Changes for Each Group | Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention | 4 years | 
| Occurrence of Tissue Level Increases | Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention | 4 years | 
| Occurrences of Disease Progression for Each Group | Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention | 4 years | 
| Occurrences of Hormonal Effect | Effect of isoflavones and lycopene on serum steroid hormones as measured by sex-hormone-binding globulin, estradiol, and free testosterone at baseline and post-study intervention | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer