Clinical Trial: S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
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 Summary:
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.
Sponsor: Southwest Oncology Group
Current Primary Outcome: Presence of Carcinoma of the Prostate as Measured by Biopsy [ Time Frame: 3 years ]
Original Primary Outcome:
Current Secondary Outcome: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: 3 months after randomization and then every 3 months for 3 years ]
Original Secondary Outcome:
Information By: Southwest Oncology Group
Dates:
Date Received: February 14, 2002
Date Started: February 2000
Date Completion:
Last Updated: January 2, 2013
Last Verified: January 2013