Published Online: December 9, 2008 (doi:10.1001/jama.2008.864).
Author Contributions: Drs Lippman and Klein had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Both contributed equally to the study.
Study concept and design: Lippman, Klein, P. Goodman, Thompson, Ford, Parnes, Minasian, Gaziano, Crawford, G. Goodman, Cook, Karp, Walther, Lieber, Ganz, Santella, Albanes, Taylor, Probstfield, Crowley, Meyskens, Coltman.
Acquisition of data: Klein, P. Goodman, Lucia, Hartline, Parsons, Bearden, G. Goodman, Claudio, Winquist, Cook, Lieber, Arnold, Jagpal, Crowley.
Analysis and interpretation of data: Lippman, Klein, P. Goodman, Thompson, Ford, Parnes, Minasian, Gaziano, Kristal, Darke, Arnold, Crowley, Baker, Coltman.
Drafting of the manuscript: Lippman, Klein, P. Goodman, Thompson, Minasian, Darke.
Critical revision of the manuscript for important intellectual content: Lippman, Klein, P. Goodman, Lucia, Thompson, Ford, Parnes, Minasian, Gaziano, Hartline, Parsons, Bearden, Crawford, G. Goodman, Claudio, Winquist, Cook, Karp, Walther, Lieber, Kristal, Arnold, Ganz, Santella, Albanes, Taylor, Probstfield, Jagpal, Crowley, Meyskens, Baker, Coltman.
Statistical analysis: P. Goodman, Darke, Arnold, Crowley.
Obtained funding: Lippman, Coltman.
Administrative, technical, or material support: Lippman, Klein, P. Goodman, Lucia, Thompson, Ford, Minasian, Hartline, Bearden, Crawford, G. Goodman, Claudio, Cook, Lieber, Ganz, Santella, Albanes, Taylor, Probstfield, Meyskens.
Study supervision: Lippman, Klein, Thompson, Ford, Minasian, Gaziano, Hartline, G. Goodman, Karp, Lieber, Probstfield, Crowley, Baker, Coltman.
Financial Disclosures: Dr Lucia reported serving as a consultant for GlaxoSmithKline and Veridex, and being a member of the Advisory Board for GenProbe. Dr Thompson reported serving as a consultant for Veridex and Mission Pharmacal (with fees paid to University of Texas Health Sciences Center, San Antonio). Dr Gaziano reported receiving investigator-initiated research funding from Veroscience, Amgen, and BASF Corporation, and research support in the form of study agents and packaging from BASF Corporation, Wyeth Pharmaceuticals, and DSM Nutritional Products Inc (formerly Roche Vitamins); serving as a consultant or receiving honoraria from Bayer AG and Pfizer; and serving as an expert witness for Merck. Dr Meyskens reported being a co-founder of Cancer Prevention Pharmaceuticals. No other authors reported financial disclosures.
Funding/Support: This work was supported in part by Public Health Service Cooperative Agreement grant CA37429 awarded by the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, and in part by the National Center for Complementary and Alternative Medicine (National Institutes of Health). Study agents and packaging were provided by Perrigo Company (Allegan, Michigan), Sabinsa Corporation (Piscataway, New Jersey), Tishcon Corporation (Westbury, New York), and DSM Nutritional Products Inc (Parsipanny, New Jersey).
Role of the Sponsor: The National Cancer Institute was involved in the design and conduct of the study, in the analysis and interpretation of the data, and in the preparation, review, and approval of the manuscript.
Active SELECT Clinical Sites With ≥100 Participants as of October 23, 2008:San Diego, U of CA: J. Kellogg Parsons, principal investigator (PI) [1743 men]; Upstate Carolina CCOP: Jay Bearden III, PI (1201 men); London Regional Cancer Program, London Health Sciences Centre: Joseph L. Chin and Eric Winquist, PIs (981 men); University of Colorado: E. David Crawford, PI (964 men); Swedish Medical Ctr: Gary E. Goodman, PI (934 men); VAMC Jesse Brown: Thomas E. Lad, PI (749 men); Harbor-UCLA: Rowan T. Chlebowski, PI (629 men); Le Centre de Recherche: Yves Fradet, PI (628 men); Altamira Family Med: Jaime Claudio, PI (610 men); Mayo, Rochester: Michael M. Lieber, PI (606 men); Capital Region Prostate Centre: Gary Steinhoff, PI (543 men); Vancouver Hospital: Mark FitzGerald, PI (423 men); Rush University Medical Center: Steven K. Rothschild, PI (385 men); MD Anderson Cancer Center: Elise D. Cook, PI (381 men); VAMC San Juan: Luis Baez, PI (359 men); SUNY Stony Brook: Iris A. Granek, PI (358); Sherbrooke University Hospital: Abdenour Nabid, PI (348 men); George Washington University: Richard J. Katz, PI (342 men); William Beaumont Hospital: David A. Decker, PI (321 men); Wilford Hall Medical Center: Kyle J. Weld, PI (309 men); Cascadia Cancer Prevention at St. Joseph Hospital: Frank E. James, PI (299 men); Dayton CCOP: Lawrence J. Litscher, PI (296 men); Grand Rapids CCOP: Marianne K. Lange, PI (287 men); VAMC Minneapolis: Timothy J. Wilt, PI (270 men); Carle Cancer Center CCOP: David L. Graham, PI (253 men); LDS Hospital: Scott Chidester, PI (250 men); University of Mississippi: Charles R. Pound, PI (238 men); Greenville CCOP: Jeffrey K. Giguere, PI (230 men); Metro-Minnesota CCOP: Alice C. Shapiro, PI (229 men); VAMC Cleveland: Donald R. Bodner, PI (227 men); Wichita CCOP: Shaker R. Dakhil, PI (219 men); Arizona Cancer Center: Frederick R. Ahmann, PI (219 men); Marshfield Clinic: Matthias Weiss, PI (215 men); University of Iowa Hospital: Richard D. Williams, PI (207 men); Baptist Hospital East: Kerry Short, PI (202 men); Downstate Medical Center: Richard J. Macchia, PI (197 men); Kalamazoo CCOP: Raymond S. Lord III, PI (181 men); Southern Nevada CCOP: John A. Ellerton, PI (173 men); Sunnybrook Health Science Center: Laurence Klotz, MD, PI (171 men); Missouri Baptist Medical Center: Paul K. Schultz, PI (170 men); Geisinger Clinic: Albert M. Bernath, PI (165 men); VAMC Kansas City: Peter J. Van Veldhuizen Jr., PI (163 men); Orocovis Med Ctr: Jose S. Aponte, PI (163 men); Sutter Health Cancer Research Group-Eastern Division: Vincent Caggiano, PI (160 men); VAMC Washington, DC: Steven H. Krasnow, PI (154 men); Bay Area CCOP: Norman R. Cohen, PI (153 men); Sentara Cancer Institute: Robert W. Given, PI (152 men); VAMC Fargo: William K. Becker, PI (151 men); Medical College of Wisconsin: Robert F. Donnell, PI (149 men); VAMC Houston: Teresa G. Hayes, PI (146 men); Baptist Regional Cancer Insitute: Neil Abramson, PI (136 men); Mount Sinai CCOP: Rogerio C. Lilenbaum, PI (134 men); Methodist Hospitals of Dallas: John V. Cox, PI (133 men); Miguel Sosa Padilla: Miguel Sosa-Padilla, PI (133 men); Kaiser Permanente: Nagendra R. Tirumali, PI (132 men); Duluth CCOP: Steven A. Kuross, PI (131 men); Stormont-Vail Health Care: Stanley J. Vogel, PI (130 men); Decatur Memorial Hospital: James L. Wade III, PI (126 men); VAMC Puget Sound: Daniel W. Lin, PI (124 men); VAMC Boston: Mary T. Brophy, PI (122 men); Scott & White CCOP: Scott Coffield, PI (119 men); Schiffler Cancer Center: Gregory S. Merrick, PI (116 men); MeritCare Hospital CCOP: Preston D. Steen, PI (115 men); Gaston Memorial Hospital: Steven W. Yates, PI (114 men); VAMC Phoenix: James V. Felicetta, PI (113 men); Lehigh Valley Hospital: Gregory R. Harper, PI (113 men); Cancer Resource Ctr: Sushil S. Lacy, PI (112 men); Holy Cross Hospital: Leonard J. Seigel, PI (112 men); Cleveland Clinic: Eric A. Klein, PI (111 men); Walter Reed AMC: Rob Dean, PI (111 men); Kaiser Permanente-GA: Joshua I. Barzilay, PI (110 men); Columbia River CCOP: Keith S. Lanier, PI (110 men); Oregon Health & Science University: Mark G. Garzotto, PI (110 men); H Lee Moffitt Cancer Center: Julio M. Pow-Sang, PI (110 men); McGill University Health Center: Simon Tanguay, PI (110 men); Vanderbilt University: Michael S. Cookson, PI (109 men); St Luke's Mountain State Tumor Institute: Thomas M. Beck, PI (107 men); Washington University: Robert L. Grubb III, PI (107 men); VAMC Southern Arizona: Maria C. Bishop, PI (106 men); Andres Grillasca: Luis Baez, PI (106 men); VAMC Hines: Nirmala Bhoopalam, PI (102 men); University of Oklahoma: Daniel J. Culkin, PI(102 men); Kaiser Permanente-Oakland: Louis Fehrenbacher, PI (100 men); St Vincent Hospital: Thomas J. Saphner, PI (100 men).
Intergroup Participants:Eastern Cooperative Oncology Group: D. Karp (chief liaison); Cancer and Leukemia Group B: P. Walther (chief liaison); North Central Cancer Treatment Group: M. Lieber (chief liaison); Radiation Therapy Oncology Group: F. Khuri (chief liaison); and Veterans Affairs Cooperative Studies Program: M. Gaziano (chief liaison).
SELECT Steering Committee: Gary E. Goodman, MD, Philip R. Taylor, MD, ScD, Powel H. Brown, MD, PhD, Paul Godley, MD, PhD, Charles Bennett, MD, PhD, Michael M. Lieber, MD, Lewis Musgrove, Ellen Richmond, MS, RN, Alan R. Kristal, DrPH, Julia E. Vertrees, PharmD, Regina M. Santella, PhD, M. Scott Lucia, MD, Demetrius Albanes, MD, Patricia A. Ganz, MD, Jeffrey L. Probstfield, MD, Neil E. Fleshner, MD, MPH, Isaac J. Powell, MD, T. J. Jagpal, CCRP, William R. Markesbery, MD, William Christen, ScD, Patricia A. Cassano, PhD, M. Peter Lance, MD, Carolyn J. Hoban, DSc, Marjorie A. Godfrey, Abbie L. Brown, Dana B. Sparks, MAT, Elaine Armstrong, MS, Frank L. Meyskens Jr, MD, Cathy Tangen, DrPH, Garnet L. Anderson, PhD, Amy Darke, MS, Katie Arnold, MS, Karen Anderson, Monica Yee, Scott M. Lippman, MD, Eric A. Klein, MD, Phyllis J. Goodman, MS, Ian M. Thompson, MD, Leslie G. Ford, MD, Howard L. Parnes, MD, J. Michael Gaziano, MD, MPH, Lori Minasian, MD, Jo Ann L. Hartline, MPH, J. Kellogg Parsons, MD, MHS, James D. Bearden, III, MD, Jaime Claudio, MD, Elise D. Cook, MD, Laurence H. Baker, DO, John J. Crowley, PhD, Charles A. Coltman Jr, MD.
SELECT Committees and Subcommittees:Recruitment and Adherence Committee: J. L. Probstfield (chair); Minority and Medically Underserved Subcommittee: E. D. Cook (chair); Health-related Quality of Life Committee: C. M. Moinpour and P. A. Ganz (co-chairs); Pathology and Biomarkers Committee: M. S. Lucia (chair); Molecular Epidemiology Committee: R. M. Santella (chair); Diet and Nutrition Committee: A. R. Kristal (chair); Site Coordinators Committee: T. J. Jagpal (chair).
Disclaimer: Dr Gaziano, a contributing editor for JAMA, was not involved in the editorial review of or decision to publish this article.
Additional Contributions: We thank the 35 533 men and many principal investigators and clinical research associates at our 427 clinical sites, whose participation in SELECT has written an important chapter in the history of cancer prevention. We also thank the many personnel of the Southwest Oncology Group (the coordinating group of this Intergroup trial), whose tireless efforts allowed SELECT to successfully complete the test of its primary hypotheses. No compensation was received.