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Simple Summary  Prostate cancer is the second most common cancer and the fifth leading cause of cancer death in men worldwide. The current diagnosis methods for prostate cancer are invasive and costly. In particular, digital rectal examination (DRE) or prostate massage adds considerable discomfort to patients, reduces compliance to cancer screening schedules, and raises the cost of the diagnostic procedure. New technologies are urgently needed for the effective and yet noninvasive detection of these conditions. This manuscript describes streamlined biotechnology for the noninvasive detection of prostate cancer from malignant cells shed in urine. For the first time, a whole-cell immunocapture approach combined with photodynamic diagnostic principles is used in a device to detect whole cancer cells from unprocessed patient urine samples collected without prior DRE.    Abstract  Urine-based biomarkers have shown suitable diagnostic potential for prostate cancer (PCa) detection. Yet, until now, prostatic massage remains required prior to urine sampling. Here, we test a potential diagnostic approach using voided urine collected without prior digital rectal examination (DRE). In this study, we evaluated the diagnostic performance of a microfluidic-based platform that combines the principle of photodynamic diagnostic with immunocapture for the detection of PCa cells. The functionality and sensitivity of this platform were validated using both cultured cells and PCa patient urine samples. Quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) demonstrated this platform had a detection limit of fewer than 10 cells per 60 µL and successfully validated the presence of a PCa biomarker in the urine of cancer patients without prior DRE. This biosensing platform exhibits a sensitivity of 72.4% and a specificity of 71.4%, in suitable agreement with qRT-PCR data. The results of this study constitute a stepping stone in the future development of noninvasive prostate cancer diagnostic technologies that do not require DRE.

Selective Microfluidic Capture and Detection of Prostate Cancer Cells from Urine without Digital Rectal Examination