Increased Plasmatic Levels of PSA-Expressing Exosomes Distinguish Prostate Cancer Patients from Benign Prostatic Hyperplasia: A Prospective Study.

Prostate Specific Antigen (PSA) fails to discriminate between benign prostatic hyperplasia (BPH) and Prostate Cancer (PCa), resulting in large numbers of unnecessary biopsies and missed cancer diagnoses. Nanovesicles called exosomes are directly detectable in patient plasma and here we explore the potential use of plasmatic exosomes expressing PSA (Exo-PSA) in distinguishing healthy individuals, BPH, and PCa. Exosomes were obtained from plasma samples of 80 PCa, 80 BPH, and 80 healthy donors (CTR). Nanoparticle Tracking Analysis (NTA), immunocapture-based ELISA (IC-ELISA), and nanoscale flow-cytometry (NSFC), were exploited to detect and characterize plasmatic exosomes. Statistical analysis showed that plasmatic exosomes expressing both CD81 and PSA were significantly higher in PCa as compared to both BPH and CTR, reaching 100% specificity and sensitivity in distinguishing PCa patients from healthy individuals. IC-ELISA, NSFC, and Exo-PSA consensus score (EXOMIX) showed 98% to 100% specificity and sensitivity for BPH-PCa discrimination. This study outperforms the conventional PSA test with a minimally invasive widely exploitable approach.

Cancers. 2019 Sep 27*** epublish ***

Mariantonia Logozzi, Daniela F Angelini, Alessandro Giuliani, Davide Mizzoni, Rossella Di Raimo, Martina Maggi, Alessandro Gentilucci, Vittorio Marzio, Stefano Salciccia, Giovanna Borsellino, Luca Battistini, Alessandro Sciarra, Stefano Fais

Department of Oncology and Molecular Medicine, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. ., Neuroimmunology Unit, IRCCS Santa Lucia Foundation, 00179 Rome, Italy. ., Environment and Health Department Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. ., Department of Oncology and Molecular Medicine, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. ., Department of Oncology and Molecular Medicine, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. ., Department of Urology, Policlinico Umberto I, Università La Sapienza, Viale dell'Università 33, 00161 Rome, Italy. ., Department of Urology, Policlinico Umberto I, Università La Sapienza, Viale dell'Università 33, 00161 Rome, Italy. ., Department of Urology, Policlinico Umberto I, Università La Sapienza, Viale dell'Università 33, 00161 Rome, Italy. ., Department of Urology, Policlinico Umberto I, Università La Sapienza, Viale dell'Università 33, 00161 Rome, Italy. ., Neuroimmunology Unit, IRCCS Santa Lucia Foundation, 00179 Rome, Italy. ., Neuroimmunology Unit, IRCCS Santa Lucia Foundation, 00179 Rome, Italy. ., Department of Urology, Policlinico Umberto I, Università La Sapienza, Viale dell'Università 33, 00161 Rome, Italy. ., Department of Oncology and Molecular Medicine, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. .