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value over routine clinical information, and the 4K model
performed significantly better than the base model in this
group. The 4Kpanel did not add predictive value to a PSA
clinical model for biopsy decision-making for men at
subsequent surveillance biopsies. This work aims to
provide clinical validation of a biomarker that will help
determine those men who have or will develop aggressive
prostate cancer, allowing for the accurate determination
of those men who may avoid or delay the burden
of immediate treatment safely, while concurrently
identifying men who may optimally benefit from early
treatment.
Author contributions:
Daniel W. Lin had full access to all the data in the
study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design:
Lin, Newcomb, Sjoberg, Dong, Zheng.
Acquisition of data:
Lin, Newcomb, Brooks, Carroll, Cooperberg, Dash,
Ellis, Fabrizio, Gleave, Morgan, Nelson, Thompson, Zheng.
Analysis and interpretation of data:
Lin, Newcomb, Brown, Sjoberg, Dong,
Nelson, Thompson, Zheng.
Drafting of the manuscript:
Lin, Newcomb, Brown, Sjoberg, Dong, Nelson,
Thompson, Zheng.
Critical revision of the manuscript for important intellectual content:
Lin,
Newcomb, Brown, Sjoberg, Dong, Brooks, Carroll, Cooperberg, Dash, Ellis,
Fabrizio, Gleave, Morgan, Nelson, Thompson, Zheng.
Statistical analysis:
Brown, Sjoberg, Dong, Zheng.
Obtaining funding:
Lin, Newcomb, Nelson, Zheng.
Administrative, technical, or material support:
Lin, Nelson.
Supervision:
Newcomb, Lin, Nelson.
Other:
None.
Financial disclosures:
Daniel W. Lin certifies that all conflicts of interest,
including specific financial interests and relationships and affiliations
relevant to the subject matter or materials discussed in the manuscript
(eg, employment/affiliation, grants or funding, consultancies, honoraria,
stock ownership or options, expert testimony, royalties, or patents filed,
received, or pending), are the following: Yan Dong is an employee of
OPKO. The remaining authors have nothing to disclose.
Funding/Support and role of the sponsor:
This work was supported by
the Department of Defense (PC130355
)
, the Canary Foundation, and the
Institute for Prostate Cancer Research. The sponsors played a role in
the design and conduct of the study, and collection, management, and
analysis of the data.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at
http://dx.doi.org/10.1016/j. eururo.2016.11.017.
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