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Factors associated with Prostate Cancer in Prostate Needle Biopsy
Proposal
1626
Title of Proposed Research
Factors associated with Prostate Cancer in Prostate Needle Biopsy
Lead Researcher
Daniel M. Moreira
Affiliation
University of Illinois at Chicago
Funding Source
None
Potential Conflicts of Interest
None
Data Sharing Agreement Date
16 December 2016
Lay Summary
Prostate cancer is the most common cancer and the second most common cause of cancer-related death in men in the United States.
In this study we seek to determine the factors that are most predictive of having prostate cancer at the time of prostate needle biopsy, including patients' demographics, medications and laboratory tests. We expect that, by analyzing such variables in multivariate models, we will be able to determine the independent predictors of cancer in prostate needle biopsy which may allow a reduction in unnecessary biopsies.
Study Data Provided
[{ "PostingID": 369, "Title": "GSK-ARI40006", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer" },{ "PostingID": 1276, "Title": "GSK-ARI103094", "Description": "ARI103094-Follow-Up Study for REDUCE Study Subjects" }]
Statistical Analysis Plan
Univariable comparisons of baseline characteristics will be performed using Fisher's exact test for categorical data and Student's t test or Kruskall-Wallis test for continuous variables. The association of baseline patient characteristics with prostate cancer detection in subsequent biopsies will be evaluated with chi-squared test or logrank test in univariable analysis, and with logistic regression or Cox proportional hazards in multivariable analysis. Kaplan-Meier curves will be generated. All statistical analyses will be two-tailed and performed using R (R Foundation for Statistical Computing, Vienna, Austria). A P value < 0.05 will considered to indicate statistical significance.
Publication Citation
https://doi.org/10.1016/j.juro.2018.06.018
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