The ROBIOPSY project aims at evolving the robotic device for prostate cancer (PC) biopsy demonstrated during the ERC-PoC PROST into a product prototype that will be ready for clinical trials. The focus of the project will be two-fold: the engineerization of the PROST prototype, and the accurate analysis of the business case of prostate cancer diagnosis and its potential extension to focal therapy. We will correct the shortcomings of the pre-clinical tests, meet the strict medical certification regulations, and address the Health Economics implications of our solution. ROBIOPSY will achieve better performance than current competitors because it solves the two main causes of PC diagnostic error: uncertain target identification, and inaccurate needle positioning, as demonstrated in the pre-clinical tests. A novel image fusion method will permit to significantly reduce the target uncertainty, while the robotic device will zero the positioning error.The ROBIOPSY prototype will consist of a single cart holding the robotic needle positioner, and housing all the electronic components. The electronics will be divided into two subsystems: interface and data processing, and safety critical controls. This will reduce the operational risks and will simplify the medical certification. A multi-centric study is ongoing to collect biopsy images to train the Machine Learning algorithms for prostate segmentation and lesion identification. In parallel to the technical development, we will analyze in depth the business case of prostate biopsy in selected European Countries, we will analyze the time/cost reduction due to the new device and will establish the economic foundation of focal therapy, to be ready for the expected evolution of PC treatments.