Selenium and Vitamin E Cancer Prevention Trial (SELECT)

Principal Investigator:
Mitchell C. Benson, M.D.
Professor of Urology
College of Physicians and Surgeons
Department of Urology
Columbia University
(212) 305-5201

Co-Investigator:                 
Aaron E. Katz, M.D.

Study Purpose: Prostate cancer is the most common cancer diagnosed in American men. The purpose of this study is to compare the effects of selenium (L-selenomethionine), vitamin E (alpha-tocopherol), selenium plus vitamin E, and placebo (a pill containing no active substances).  We want to determine whether the supplements compared to the placebo can prevent or reduce the occurrence of prostate cancer.

Past studies of selenium and vitamin E suggested that these agents might reduce the incidence of prostate cancer. No large scale study has investigated the effects of these supplements either alone or in combination in preventing prostate cancer.

Study subjects and method of recruitment: About 32,400 men will be enrolled in this study and followed for 7 to 12 years.  Patients at the NewYork-Presbyterian Hospital Columbia campus are potentially eligible to participate in this study.

To be eligible, men must be in good health and not have a history of prostate cancer.  African American men age 50 or older and other men age 55 or older are eligible. Prostate cancer appears at younger ages in African American men than others.

Study procedures: Participants will be randomized to one of four groups: selenium alone, vitamin E alone, both and neither.

• During the first year, participants will have a visit for randomization and then will be contacted after three and nine months by phone to see how they are doing. 
• Participants will have office visits every six months and have their remaining pills counted.  Participants will receive a limited medical exam every year.  If participants wish, they may also have a yearly exam of their prostate (digital rectal examination) and a yearly blood test (prostate specific antigen-PSA) to look for evidence of prostate cancer. 
• During this study, participants may have to have surgery or a biopsy of their prostate.  If the tissue from the surgery is either suspicious for cancer or has pre-cancerous changes (high grade prostatic intraepithelial neoplasia-PIN), tissue samples will be sent to a SELECT central laboratory for confirmation. 
• Participants will also have blood drawn at some follow-up visits to test the level of vitamin E and selenium in their blood.  This blood draw will be done prior to randomization and at six months, one year, two years, four years, six years, eight years and ten years after participants begin the study.

There are also a few optional programs in which participants may be interested in participating, but they are not mandatory for participation in the SELECT study.

Contact: Erica Golliday at 212-307-0347