Clinical Trial: Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
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 Summary:
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 (REDUCE and 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: PSA detection-bias of PCa risk-
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome:
- PSA Discussion with Physician 3 months, measured by survey [ Time Frame: 3 months ]Discussion with Physician regarding PSA screening, measured by survey 3 months after provision of risk information
- PSA testing 3 months, measured by survey [ Time Frame: 3 months ]PSA screening, measured by survey 3 months after provision of risk information.
- PSA testing 3 years [ Time Frame: 3 years ]PSA screening, measured by medical records 3 years after provision of risk information.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Anxiety, measured by state-trait anxiety inventory (STAI) [ Time Frame: 0 ]Immediate reaction to risk information. Measured by state-trait anxiety inventory (STAI)
- Chemoprevention discussion with Physician 3 months, measured by survey [ Time Frame: 3 months ]Discussion with Physician regarding chemoprevention, measured by survey 3 months after provision of risk information
- Chemoprevention uptake 3 months, measured by survey [ Time Frame: 3 months ]Uptake of chemoprevention, measured by survey 3 months after provision of risk information.
- Risk Recall immediate, measured by survey [ Time Frame: 0 ]Immediate recall of risk information. Measured by survey.
- Risk Recall 3 month, measured by survey [ Time Frame: 3 month ]3 month recall of risk information. Measured by survey.
Original Secondary Outcome: Same as current
Information By: Wake Forest University Health Sciences
Dates:
Date Received: February 28, 2015
Date Started: June 2011
Date Completion:
Last Updated: March 5, 2015
Last Verified: February 2015
