MP30-17 A DOUBLE BLIND, PROSPECTIVE STUDY FOR PROSTATE CANCER DIAGNOSIS IN URINE SAMPLE: ACCURACY OF THE ELECTRONIC NOSE COMPARED TO HIGHLY TRAINED DOGS
INTRODUCTION AND OBJECTIVE:
The diagnostic accuracy in urine sample for prostate cancer (PCa) in highly trained dogs was studied and high performance in terms of sensitivity and specificity was demonstrated. What dogs are able to smell is still unknown but is thought that could be volatile organic compounds (VOCs). However, in clinical practice, using dogs for PCa diagnosis is problematical to be applied. Electronic noses were developed and widely used for the different fields of industries. Thanks to the collaboration between Humanitas hospitals group and Natta Institute of Politecnico di Milano have been developed a new type of electronic nose (e-nose) with specific feature for detecting PCa. The aim of this study is to compare the PCa diagnosis accuracy of e-nose versus highly trained dogs in urine sample.
This is an ongoing, double-blind, prospective cohort study. Urine samples were collected consecutively from patients divided into 2 groups: (PCa Group): Men with biopsy-proven PCa (any stage and grade); (Control group) Healthy men and women affected by different benign and malignant pathologies without PCa. Each patient filled 2 urine containers with 30cc and then frozen. The first samples were transferred to the military veterinary center of the Italian Ministry of Defense in Grosseto (CEMIVET), where 2 German Shepherd Explosion Detected Dogs, trained to identify PCa VOCs in urine, “tested” them. The second samples were transferred to the Natta Institute of Politecnico di Milano to be analyzed by e-nose.
Overall, 126 subjects were included in the study: 66 (52.4%) in PCa Group, 60 (47.6%) in Control group. The median age (years) for group 1 was 64 ( IQR 60-68), and 46 (24.5-65) for group 2. In group 2, 15 (25.0%) were women and 45 (75.0%) men. For dog 1 the sensitivity (SE) was 100% (95% CI 98.0-100) and the specificity (SP) 98.2% (95% CI 97.2-99.3). For dog 2 SE it was 97.6% (95% CI 95.6.0-98.9) and SP 96.9% (95% CI 95.9-98.1). When only men aged ≥45 years are considered, for dog 1 SE was 100% (95%CI 98.9-100) and SP 97.0% (95% CI 96.0-98.1), while for dog 2 SE it was 97.1% (95% CI 94.0-98.2) and SP 96.0 (95% CI 94.5-97.2). Overall, e-nose SE was 85.0% (95% CI 83.0-93.1) and SP 82.0% (95%CI 76.0-85.7). When considering only men aged ≥45 years, the SE was 84.0% (95% CI 82.3-93.5) and the SP 80.0% (95% CI 77.2-84.6).
The diagnostic performance of the e-nose in recognizing specific PCa VOCs in urine samples is high and promising. Our study is ongoing and the development of e-nose is still improving. Nevertheless, the diagnostic performance of dogs is amazing and fascinating, the e-nose has the potential to become a feasible, easily reproducible, low cost, highly accurate test to be applied in clinical practice.
Source of Funding: