S0000 Selenium and Vitamin E in Preventing Prostate Cancer

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.

Conditions

• Prostate Cancer

Interventions

DRUG

Vitamin E

400 IU daily by mouth for 7-12 years

DRUG

Selenium

200 mcg daily for 7-12 years

OTHER

Vitamin E placebo

daily for 7-12 years

OTHER

selenium placebo

daily for 7-12 years

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• NCIC Clinical Trials Group

  collaborator NETWORK

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Eric Klein, MD · The Cleveland Clinic

• Philip J. Walther, MD, PhD · Duke University

• Laurence H. Klotz, MD · Toronto Sunnybrook Regional Cancer Centre

• Scott M. Lippman, M.D. · MD Anderson

• Ian M. Thompson, M.D. · University of Texas

• J. Michael Gaziano, M.D. · MAVERIC

• Daniel D Karp, M.D. · Beth Israel Deaconess

• Fadlo R. Khuri, M.D. · MD Anderson

• Michael M Lieber, M.D. · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

50 Years

Max Age

120 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2001-07-31

Primary Completion

2011-05-31

Completion

2012-09-30

Countries

• United States

Study Locations