L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Presence of Carcinoma of the Prostate as Measured by Biopsy
The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.
Jim Marshall, PhD
Roswell Park Cancer Institute
United States: Federal Government