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Home > "V" Clinical Trials Conditions > Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia  Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in preventing the development of prostate cancer. PURPOSE: Randomizedphase II trial to study the effectiveness of combining vitamin E, selenium, and soy protein in preventing prostate cancer in patients who have high-grade prostate neoplasia.
Details: OBJECTIVES: - Determine whether nutritional supplementation with soy protein isolate, vitamin E, and selenium can delay the time to development of invasive prostate cancer (disease-free survival) in patients with high-grade prostatic intraepithelial neoplasia. - Determine the effect of this supplementation on intermediate endpoints that may reflect a lessened risk of invasive prostate cancer (e.g., serum PSA levels, hormone levels, lycopene, malondialdehyde, vitamin E, and reduced thiol groups) in these patients. - Determine the safety of this supplementation in these patients. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral vitamin E, oral selenium, and oral soy protein isolate twice daily. - Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 3 years in the absence of invasive prostate cancer (demonstrated on biopsy) or unacceptable toxicity. Patients are followed every 6 months for 1 year and then annually for 2 years. PROJECTED ACCRUAL: A total of 306 patients (153 per treatment arm) will be accrued for this study within 6 years.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed high-grade prostatic intraepithelial neoplasia (HGPIN) - No evidence of invasive prostate cancer by at least 2 biopsies within the past 18 months - At least 1 biopsy must show evidence of HGPIN within the past 6 months - No prior invasive prostate cancer PATIENT CHARACTERISTICS: Age - Not specified Performance status - Not specified Life expectancy - More than 5 years Hematopoietic - Platelet count at least 75,000/mm^3 - No coagulopathies Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - PT (INR) no greater than 1.5 times ULN - PTT no greater than 1.5 times ULN - No hepatic insufficiencies Renal - Creatinine no greater than 2 times ULN - No renal insufficiencies Other - No prior nonmelanoma skin cancer (e.g., squamous cell or basal cell carcinoma) - No other malignancy within the past 5 years except superficial bladder cancer - No known bowel malabsorption - No dietary behavior (e.g., morbid obesity or eating disorders) that would limit adherence to study therapy - No major illness, including psychiatric illness, that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - More than 3 months since prior androgen therapy - More than 3 months since prior hormonal therapy for benign prostatic hyperplasia (e.g., finasteride) - No concurrent finasteride - No concurrent androgen therapy Radiotherapy - More than 2 years since prior radiotherapy to the pelvic region Surgery - Not specified Other - More than 2 weeks since prior supplemental vitamin E or selenium - No other concurrent vitamin E (greater than 100 IU/day), selenium, or soy protein isolate (more than 2 servings/week) - No other concurrent treatment for high-grade prostatic intraepithelial neoplasia
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NeilFleshner, Study Chair, Princess Margaret Hospital
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Laurence Klotz 416-480-4673
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Ricardo Rendon 902-473-6118
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Neil Fleshner 416-946-2899
Additional Information:
Study ID Numbers: CDR0000310096; CAN-NCIC-PRP1
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064194
Other Prostate Cancer Studies:
1. Lycopene In Preventing of Prostate Cancer
2. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
3. Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
4. Study of Prostate Cancer in Black and White U.S. Veterans
5. A Phase III, Randomized Study of Atrasentan in Men with Metastatic, Hormone-Refractory Prostate Cancer
Related Studies:
Other Prostate Cancer Clinical Trials
Other Nova Scotia Clinical Trials
Other Halifax Clinical Trials
Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
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