Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
SWOG Cancer Research Network
With
OBJECTIVES: * Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia. * Compare the toxicity of these regimens in these patients. * Compare the effects of these regimens on the rate of increase in prostate-specific antigen (PSA) in these patients. * Compare the effects of these regimens on prostatic cellular proliferation and apoptosis, degradation of basal cell integrity of prostatic ducts, and changes in nuclear chromatin patterns in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms. * Arm I: Patients receive oral selenium once daily. * Arm II: Patients receive oral placebo once daily. Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually for 8 years. PROJECTED ACCRUAL: A total of 465 patients will be randomized for this study.
Age
40–any
Sex
MALE
Healthy volunteers
Not accepted