Conditions: Precancerous/Nonmalignant Condition Prostate Cancer
Keywords: prostate cancer high grade prostatic intraepithelial neoplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 619
Healthy volunteers: no

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate.

PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.

Detailed description:
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.

Arms:
arm 1: L-selenomethionine (Selenium)one tablet by mouth daily for 3 years. arm 2: L-selenomethionine placebo one tablet by mouth daily for 3 years

Interventions: intervention 1: L-selenomethionine intervention 2: L-selenomethionine placebo
Intervention descriptions: intervention 1: Randomization between active L-selenomethionine and placebo intervention 2: Randomization between active L-selenomethionine and placebo

Protocol document: