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Non-DRE Voided Urine Test to Diagnose Prostate Cancer: Updated Results
Patrick T Gomella1, Joon Yau Leong1, Leonard G Gomella1
1Department of Urology, Thomas Jefferson University, Philadelphia, PA 19107, USA.
Diagnostics (Basel, Switzerland)
|March 13, 2025
Summary
A novel optical assay detects prostate cancer (PCa) malignant cells (MC) in urine by targeting VPAC receptors. This noninvasive method shows increasing MC shedding and fluorescence intensity with higher PCa severity, offering a reliable, cost-effective preliminary detection tool.
Area of Science:
- Oncology
- Biotechnology
- Medical Diagnostics
Background:
- Standard prostate cancer (PCa) diagnosis relies on PSA testing, DRE, and biopsies, which are invasive and costly.
- Research is exploring alternative, less invasive methods like serum and urine assays for PCa detection.
- A novel noninvasive optical technique targets VPAC receptors overexpressed on PCa malignant cells (MC).
Purpose of the Study:
- To validate a novel noninvasive optical technique for detecting PCa in non-DRE voided urine.
- To assess the correlation between VPAC receptor expression on MC and PCa severity.
- To evaluate the assay's specificity and reliability compared to existing methods.
Main Methods:
- Collected non-DRE voided urine samples from 62 PCa patients and 97 BPH patients.
- Incubated urine cells with TP4303 fluorophore targeting VPAC receptors and DAPI for nuclear staining.
- Analyzed cell counts and fluorescent intensity using microscopy and specialized software.
Main Results:
- PCa malignant cells (MC) were detected in voided urine, with increasing shedding and fluorescence intensity correlating with higher Gleason grades.
- The assay demonstrated 89.6% specificity for BPH patients.
- A 100% negative predictive value (NPV) was observed for BPH patients.
Conclusions:
- PCa MC can be detected in non-DRE voided urine by targeting VPAC receptors.
- The quantity of MC shed and fluorescence intensity correlate with PCa severity.
- This optical urine assay offers a simple, noninvasive, and potentially cost-effective preliminary detection method for PCa.

