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Prostate cancer marker panel with single cell sensitivity in urine
Kristen P Nickens1, Amina Ali, Tatiana Scoggin
1Department of Surgery, Center for Prostate Disease Research, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
The Prostate
|March 27, 2015
Summary
A new urine test shows promise for detecting prostate cancer (CaP) cells after a digital rectal exam (DRE). This minimally invasive assay offers potential for earlier and more accurate CaP diagnosis, improving upon current methods.
Area of Science:
- Urology
- Oncology
- Biomarker Discovery
Background:
- Elevated PSA levels lead to over a million prostate biopsies annually in the US, with many negative for cancer.
- Current PSA tests and biopsies have limitations, driving the need for improved prostate cancer (CaP) detection methods.
- Novel urine-based assays (e.g., PCA3, TMPRSS2-ERG) and blood tests (e.g., PHI, 4K) are emerging for more precise CaP detection.
Purpose of the Study:
- To develop and evaluate the Urine CaP Marker Panel (UCMP) assay.
- To achieve sensitive and reproducible detection of CaP cells in post-digital rectal examination (post-DRE) urine.
Main Methods:
- Urine cellular content captured on filter membranes for microscopy and immuno-cytochemistry (ICC).
- Cells assayed for prostate epithelial markers (PSA, Prostein) and CaP markers (ERG, AMACR).
- Quantitative and qualitative analysis of immunostained cells correlated with biopsy results.
Main Results:
- Assay optimized for single-cell capture sensitivity using CaP cell lines.
- Feasibility cohort of 63 post-DRE urine specimens assessed.
- UCMP assay showed 64% sensitivity and 68.8% specificity for CaP detection compared to biopsy.
Conclusions:
- This pilot study demonstrates the potential of a minimally invasive CaP detection assay.
- The UCMP assay platform offers single-cell sensitivity for capture and characterization from post-DRE urine.
- Further development of this novel assay platform is warranted for improved prostate cancer diagnosis.

