Study concept and design: Bosland, Kato, Zeleniuch-Jacquotte.
Acquisition of data: Bosland, Kato, Zeleniuch-Jacquotte, Schmoll, Enk Rueter,
Melamed, Kong, Macias, Kajdacsy-Balla, Lumey, Walden, Lepor, Taneja, Randolph, Schlicht,
Analysis and interpretation of data: Bosland, Zeleniuch-Jacquotte, Enk Rueter,
Xie, Gao, Deaton.
Drafting of the manuscript: Bosland, Kato, Zeleniuch-Jacquotte, Lumey.
Critical revision of the manuscript for important intellectual content: All
Statistical analysis: Bosland, Xie, Gao.
Obtained funding: Bosland.
Administrative, technical, and/or material support: Bosland, Kato,
Zeleniuch-Jacquotte, Schmoll, Enk Rueter, Lumey, Walden, Lepor, Taneja, Randolph, Schlicht,
Meserve-Watanabe, Deaton, Davies.
Study supervision: Bosland, Kato, Zeleniuch-Jacquotte, Melamed, Kajdacsy-Balla,
Conflict of Interest Disclosures: All authors
have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr
Taneja reports that he has served as consultant for Eigen, Gtx, and Bayer and as a speaker for
Janssen, receives royalties from Elsevier, and is a clinical trial investigator for Steba. No other
disclosures were reported.
Funding/Support: This work was supported in part by
National Institute of Health grants U01 CA072290 and R01
CA166195 as well as National Institute of Health grants P50 CA16087 and UL1 TR000050, with minor
support from the Prevent Cancer Foundation and the
United Soybean Board. Solae
LLC provided the intervention materials.
Role of the Sponsor: The funding organizations had no role in the design and conduct
of the study; collection, management, analysis, and interpretation of the data; preparation, review,
and approval of the manuscript; or decision to submit the manuscript for publication. Solae LLC
developed and provided the intervention materials and reviewed parts of the manuscript for
Additional Contributions: We thank all study participants for their dedicated
contributions and we gratefully acknowledge the contributions of Nikola Baumann, PhD (University of
Illinois at Chicago), for help with the validation of the PSA assay and Pablo Torre, MD (Manhattan
VA Medical Center), for his help in recruiting participants. We also thank David M. Albala, MD (Duke
University), Nagi Kumar, PhD (Moffitt Cancer Center), Anne R. Simoneau, MD (Long Beach VA), Gregory
P. Zagaya, MD (University of Chicago), and Michael L. Howard, MD (Rotolo Howard and Leitner
Associates), for enrolling study participants, as well as all members of the various incarnations of
the data safety and monitoring board of this study. Drs Albala, Kumar, and Zagaya received
compensation on a per-participant basis via a subcontract to their institution; the others did not
receive compensation. This article is dedicated to the memory of Ernst L. Wynder, MD, who was the
first to propose that a prostate cancer prevention study with a soy intervention be conducted.