Prostate Cancer Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Randomized Study Of Combination Vitamin E, Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial Neoplasia
Verified date | April 2020 |
Source | Canadian Cancer Trials Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: Randomized phase III 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.
Status | Completed |
Enrollment | 310 |
Est. completion date | April 30, 2008 |
Est. primary completion date | April 30, 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
NCIC Clinical Trials Group |
Canada,
Fleshner NE, Kapusta L, Donnelly B, Tanguay S, Chin J, Hersey K, Farley A, Jansz K, Siemens DR, Trpkov K, Lacombe L, Gleave M, Tu D, Parulekar WR. Progression from high-grade prostatic intraepithelial neoplasia to cancer: a randomized trial of combination — View Citation
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