Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT).
Prostate cancer continues to be a major health threat, especially among African American men. The Selenium and Vitamin E Cancer Prevention Trial (SELECT), which opened on July 25, 2001, was planned to study possible agents for the prevention of prostate cancer in a population of 32,400 men in the United States, including Puerto Rico, and Canada. SELECT is a phase III randomized, placebo-controlled trial of selenium (200 microg/day from L-selenomethionine) and/or vitamin E (400 IU/day of all rac alpha-tocopheryl acetate) supplementation for a minimum of 7 years (maximum of 12 years) in non-African American men at least 55 years of age and African American men at least 50 years of age. SELECT is a large, simple trial that conforms as closely as possible with community standards of care. This commentary discusses the design problems the SELECT investigators had to resolve in developing the trial, including the role of prostate cancer screening, the best forms and doses of the study agents, and estimation of the event (prostate cancer) rate of men on the placebo arm.
Lippman
Scott M
SM
The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030-4009, USA. slippman@mdanderson.org
Goodman
Phyllis J
PJ
Klein
Eric A
EA
Parnes
Howard L
HL
Thompson
Ian M
IM
Kristal
Alan R
AR
Santella
Regina M
RM
Probstfield
Jeffrey L
JL
Moinpour
Carol M
CM
Albanes
Demetrius
D
Taylor
Philip R
PR
Minasian
Lori M
LM
Hoque
Ashraful
A
Thomas
Sarah Moody
SM
Crowley
John J
JJ
Gaziano
J Michael
JM
Stanford
Janet L
JL
Cook
Elise D
ED
Fleshner
Neil E
NE
Lieber
Michael M
MM
Walther
Philip J
PJ
Khuri
Fadlo R
FR
Karp
Daniel D
DD
Schwartz
Gary G
GG
Ford
Leslie G
LG
Coltman
Charles A
CA
D001741:Black or African American; D000368:Aged; D016588:Anticarcinogenic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002170:Canada; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D011647:Puerto Rico; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012643:Selenium / Q000627:therapeutic use*; D014481:United States; D014810:Vitamin E / Q000627:therapeutic use*
D016588:Anticarcinogenic Agents; D014810:Vitamin E; D012643:Selenium