Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
NCT ID: NCT02381015
Last Updated: 2019-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
700 participants
INTERVENTIONAL
2011-06-30
2012-06-30
Brief Summary
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Detailed Description
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Prostate cancer (PCa) is the most common cancer among men in the U.S. One important strategy to address this public health concern is to prevent the disease. Two large randomized clinical trials, The Prostate Cancer Prevention Trial (PCPT) and The Reduction by Dutasteride of Prostate Cancer Events (REDUCE), have demonstrated a 23-25% reduction in PCa risk with the use of 5 alpha reductase inhibitors (5ARIs: finasteride and dutasteride). However, 5ARIs have not been widely adopted due, in part, to poor cost-effectiveness. We hypothesize that targeted chemoprevention, based on 1) overall genetic risk \[family history (FH) and PCa risk-associated genetic variants\], and 2) polymorphisms that interact with 5ARIs, may be more efficacious and cost-effective, and thus more likely to be employed by physicians and their patients. The effectiveness of this genomic-targeted approach needs to be systematically evaluated and compared to non-genomic approaches using evidence-based methods such as those recommended by the EGAPP (Evaluation of Genomic Applications in Practice and Prevention) working group. We have assembled a multidisciplinary research team to address an overarching question of whether a genomic-targeted approach improves outcomes related to chemoprevention of PCa using 5ARIs compared to a non-targeted approach. We will evaluate and compare the efficacy, perception, decision making, and cost-effectiveness of genomic and non-genomic approaches in two existing large randomized clinical trials (Reduction by Dutasteride of Prostate Cancer Events (REDUCE) and Prostate Cancer Prevention Trial (PCPT)), two new study populations of men at risk for PCa, and in a survey of physicians. The unique study design of REDUCE and PCPT, with end-of-study prostate biopsies, allows us to address two critical questions in this study: Prostate Specific Antigen (PSA) detection-bias of PCa risk-associated Single Nucleotide Polymorphisms (SNPs) and efficacy of genomic-targeted chemoprevention of PCa using 5ARIs. We have the following specific aims: 1) assess the clinical validity of PCa risk prediction models using a panel of non PSA detection biased PCa risk-associated SNPs. 2) identify and assess the clinical validity of novel polymorphisms that interact with 5ARIs in reducing PCa diagnosis using both genome-wide and candidate gene approaches, 3) assess the clinical utility of a genomic-targeted approach by comparing its reduction in rates of PCa with non-targeted chemoprevention, 4) compare perception and decision making of physicians and patients for genomic and non-genomic-targeted chemoprevention of PCa, and 5) Compare the cost-effectiveness of genomic and non-genomic-targeted chemoprevention of PCa. Results from this study will provide comprehensive data for evidence-based evaluation by the Center for Disease Control's Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group, provide a proof of principle study of Comparative Effectiveness Research (CER), and will help build a road map for future Genomic and Personalized Medicine (GPM) in the 21st century.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Genetic Risk Score: Number Format
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format
Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
Genetic Risk Score: Number + Pictograph
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph
Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Family History: Number Format
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format
Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Family History: Number + Pictograph
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph
Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Interventions
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Genetic Risk Score: Number Format
Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
Genetic Risk Score: Number + Pictograph
Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Family History: Number Format
Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Family History: Number + Pictograph
Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
49 Years
MALE
Yes
Sponsors
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Van Andel Research Institute
OTHER
Spectrum Health Medical Group
UNKNOWN
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Endeavor Health
OTHER
Responsible Party
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Jianfeng Xu
Professor of Human Genomics and Personalized Medicine, Epidemiology, Cancer Biology, and Urology
Principal Investigators
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Jianfeng Xu, Dr.P.H.
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Other Identifiers
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IRB00011784
Identifier Type: -
Identifier Source: org_study_id
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