Prostate cancer is the most frequent malignant neoplasm and the second leading cause of cancer death among men, with a steady increase in trend due to the overall length of life expectancy. As a high prevalence disease, extreme attention should be paid to the impact of the socio-sanitary costs arising from the diagnostic and therapeutic paths to be employed. While considering such a strong epidemiological implication, diagnostic procedures to detect this tumor have not undergone substantial alterations in recent decades, so much so that histologic diagnosis by echo-guided needle biopsy remains the only viable procedure. It should be pointed out that performing a prostate biopsy exposes the patient to the risk of developing complications that, although generally of poor clinical relevance, may in any case affect the general condition of the patient. The rate of complications also increases considerably in the case of patients who have to carry a very large number of tissue withdrawals or even repeat the biopsy several times over the course of life due to the persistence of clinical suspected presence of a prostate tumor. Despite the technological progress of radiological instrumental investigations with which to study the patient (RM multiparamater), as well as the ultrasound systems needed to perform the biopsy, remains a false negative rate that swings around 30%.
This critical element raises the issue of achieving a greater level of accuracy in the estimate of the prostate area in which to pick up the tissue, together with greater precision in the execution of the withdrawal, to overcome the difference in manuality among the operators. The primary goal of our project is to effectively increase the diagnostic capacity of prostate biopsy, in particular in terms of specificity, reducing the number of false negatives, to a halt. To achieve this goal, we propose the production of the prototype of an advanced biopsy system that is capable of performing high-precision testing and integrating the functions of:
- a robotic arm, which simultaneously manages the motion of the transplotted endocavitary ultrasound probe (necessary for guiding the execution of the bioptic pick-up) and the introducer on which to pass the needle for tissue pick-up;
- an autonomous control system that uses the results of the image processing software to plan and control the motion of the needle and probe to modulate the correct input angle, needle speed, and depth of picking, to perform the drawings with maximum reliability and with a minimum margin of error;
- an image fusion computer software that integrates the prostate (formerly performed by the patient) Magnetic Resonance Imaging (RM) and ultrasound images provided in real time by providing a three-dimensional model to precisely target the "targets" "Towards which point the bioptic pick;
- an optical fiber probe, which can detect the organ's analysis and transmit data collection software, information about the same-morphological parameters and bio-markers;
- a predictive medicine computer software that detecting the morpho-functional parameters recorded by the fiber-sensed probe provides a reliable estimate of the presence or absence of prostate cancer and its aggressiveness.
The proposal in question responds fully to the prerequisites of translational research in an oncology field and is perfectly in line with the promotion of research and innovation to support better health for all. It is, in fact, an ideal model of the bridge between bio-engineering science and medicine, crucial to providing innovative and reliable methods for patients to improve their diagnosis and care. Increasing the diagnostic power of prostate biopsy means achieving concrete benefits for the patient, for the operator, for healthcare expenditure.
In detail, the expected improvements may concern: the number of prostate tissue samples to be taken for examination (reduction), the number of biopsies that the patient should undergo during life to get a diagnosis (reduction), the risk of complications associated with biopsy (reduction), concordance between the examination of the sample taken from the biopsy and the final examination of the organ surgically removed (increase), both direct and indirect costs of healthcare expenditure to diagnose prostate cancer (reduction).