Abstract
Simple SummaryProstate 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.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.
Highlights
Introduction distributed under the terms andProstate cancer (PCa) is the second most commonly diagnosed cancer and the fifth leading cause of cancer death in men worldwide [1]
The plasma deposited polyoxazoline (PPOx) films were functionalized with anti-prostate-specific membrane antigen (PSMA) antibodies in order to selectively bind prostate cancer (PCa) cells from urine
We identified the diagnostic accuracy of urinary prostate cancer antigen 3 (PCA3) and/or PSMA mRNA expression detected by Quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR)
Summary
Introduction distributed under the terms andProstate cancer (PCa) is the second most commonly diagnosed cancer and the fifth leading cause of cancer death in men worldwide [1]. Prostate cancer screening includes digital rectal examination (DRE) and a blood test for prostate-specific antigen (PSA). The results from these screening tests do not provide a definite diagnostic conditions of the Creative Commons. But are used to decide whether or not a tissue biopsy examination is warranted [2,3]. A PSA level above 4 ng mL−1 (standard cut-off value) has been accepted as the threshold to recommend a biopsy. The IMPACT (Identification of Men with a genetic predisposition to ProstAte Cancer) study proposed annual PSA screening in the population with germline breast cancer 1/2 early-onset (BRCA1/2) and prostate biopsy if PSA level above 3 ng mL−1 [4]. PSA testing has poor specificity in the range
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