Quantification of urinary exosomal PSA for the diagnosis of prostate cancer: a study protocol with emphasis on application of clinical laboratory-based techniques (Preprint)

Abstract

Background: Prostate cancer is the most common cancer in men and represents a major problem of public health. The current method of diagnosing/screening for prostate cancer is invasive and costly. There have been renewed and innovative studies on searching urinary biomarker for prostate cancer diagnosis, especially with the technologies of urinary exosomes. However, the technologies of urine exosomes usually need expensive machines such as ultracentrifuge and they are difficult to standardization, which hinder their application in clinical laboratory.Objective: In this study, our objective is to detect urinary exosomes from prostate cancer for the development of a test to aid in the diagnosis of prostate cancer. Methods:The methods include the collection of first-void urine by using Colli-Pee device, the isolation of urine exosome by optimized precipitation method and the detection of exosomal PSA by Elecsys® total PSA. We have modified and optimized the isolation of urinary exosomes with precipitation method. Results:We have found the urinary exosomal PSA can be quantified by automatic technique of Elecsys® total PSA. We have received the ethic approval. It will be a 2.5-year study. We shall start to include the patients and controls in July 15, 2024. We expect to start the data analysis in July of 2025. Conclusions:To our knowledge, it is the first study to detect the urinary exosomal PSA by the technique of Elecsys® total PSA for the diagnosis of prostate cancer. This study emphasizes on the techniques suitable for the implementation in clinical laboratory, which will facilitate application of urinary exosomes to simplify and improve the diagnosis/screening of prostate cancer.