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Clinical Trial Summary

This study collects urine from male patients seen at the urology clinic to detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in the laboratory, which targets certain biomarkers expressed on prostate cancer cells. The information learned from this study may allow researchers develop a simple diagnostic test for the management of those patients who have elevated prostate specific antigen (PSA) and are suspected to have prostate cancer. It may also help researchers understand the genetic risk factors associated with prostate cancer.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in our laboratory, which targets vasoactive intestinal polypeptide receptor 1 (VPAC1) receptors expressed on prostate cancer cells and validates the results with prevailing condition of the patients/volunteers and evaluate diagnostic accuracy. SECONDARY OBJECTIVES: I. To establish if the malignant cells as a percent of total cell shed in the urine. II. To establish the fluorescence intensity around malignant cells. III. To establish if the VPAC protein quantity in shed malignant cells correlate with the aggressiveness of the disease. OUTLINE: Patients undergo collection of urine samples at baseline during standard of care office/clinic visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04788277
Study type Observational [Patient Registry]
Source Thomas Jefferson University
Contact
Status Active, not recruiting
Phase
Start date February 26, 2020
Completion date June 2025

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