Clinical trial NCT02381015: Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
Official title: Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Cancer, Familial
Hereditary Prostate Cancer
Keywords: Genetic testing
Genomic testing
Chemoprevention
Prostate Specific Antigen
Prostate Cancer
Predictive Genetic Testing
Genetic Counseling
Prostate-Specific Antigen
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Van Andel Research Institute
name: Spectrum Health Medical Group
name: National Cancer Institute (NCI)
name: Wake Forest University Health Sciences
First posted: 2015-03-06
Enrollment: 700
Sex: MALE
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study was designed to compare the efficacy, perception, decision making, and cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate cancer and for chemoprevention of prostate cancer.

Detailed description: ABSTRACT: This clinical trial registration is focused on Aim 4 within the overall project described in the following.

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.

Eligibility criteria: Inclusion Criteria:

* age 40 to 49 years, self-defined Caucasian background, and no prior prostate specific antigen (PSA) screening nor prostate cancer (PCa) diagnosis.

Exclusion Criteria:

* outside of age range, or not self defined Caucasian background, or a prior history of PSA screening or PCa diagnosis

Primary outcomes:
measure: Number of Participants Who Had Prostate Specific Antigen (PSA) Discussion With Physician at 3 Months, Measured by Survey
timeFrame: 3 months
measure: Number of Participants Who Had PSA Testing at 3 Months, Measured by Survey
timeFrame: 3 months
measure: Number of Participants Who Had PSA Testing at 3 Years, Measured by Medical Records
timeFrame: 3 years
Secondary outcomes:
measure: Anxiety, Measured by State-trait Anxiety Inventory (STAI)
timeFrame: Baseline
measure: Accuracy of Immediate Recall of Risk Information Measured by Survey
timeFrame: Baseline
measure: Accuracy of Recall of Risk Information at 3 Months Measured by Survey
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jianfeng Xu, Dr.P.H.
role: PRINCIPAL_INVESTIGATOR
References: