DESCRIPTION (provided by applicant): The long-term goal of the project is to bring to the market a new tool for prostate cancer screening, the Prostate Mechanical Imager (PMI), which provides real time 3-D reconstruction of prostate capturing its geometrical and mechanical characteristics and aids in detecting tissue abnormalities. The current PMI prototype has undergone several progressions of hardware and software development leading to the final device concept validated in model experiments and in clinical studies which have yielded promising results. ProUroScanTM is the first PMI commercial device to be developed, clinically tested and submitted for FDA approval in the course of the proposed project. Digital records obtained by ProUroScanTM could be used to document palpable prostate abnormalities and to monitor disease progression over time. The ProUroScanTM will include a transrectal probe comprising force sensor arrays and a motion tracking system, a compact electronic unit with single electronic board powered through USB port from a laptop with touch screen capability and a wireless color printer. As a separate component, an automatic calibration setup for tactile sensor testing, tuning and calibration will be designed and built. Specific aims of the proposed project include PMI hardware and software refinements. The hardware development will include several technological improvements in the PMI transrectal probe and data acquisition board. Software for prostate 3-D real-time reconstruction and nodule detection will be refined and validated. Substantial amount of effort will be committed to assure the activities and resulting design of the PMI development comply with regulatory requirements. A key focus of pre-commercialization engineering will be on completing the design history file, verification, validation and safety certification testing. Two-stage clinical studies will be conducted at the Robert Wood Johnson Medical Center (New Brunswick, NJ) and at VA Medical Center (Minneapolis, MN) to document system safety and efficacy. The focal point of all proposed activities and the endpoint of the grant will be preparation and submission of the PMA application for the FDA approval of PMI. The core partnership was established between Artann and ProUroCare, publicly traded medical device company, to ensure commercialization success of the PMI. ProUroCare has committed necessary financial and managerial resources for regulatory clearance and commercialization of the PMI technology to complement NIH support of the project. There is a $50 billion prostate-related market with estimated 40 - 60 milion adult males suffering from one or more prostate conditions. Industry analysts believe that only 10 - 15% of incidents are reported, stressing the urgent need for new screening technologies. The goal of this project is to develop ProUroScanTM, a cost- effective, portable and easy-to-use imaging device for detecting and documenting palpable prostate abnormalities and monitoring disease progression over time.