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 to 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04788277.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Einstein Medical Center PhiladelphiaStatus: Active
Contact: Madhukar Thakur
Thomas Jefferson University HospitalStatus: Active
Contact: Madhukar Thakur
Phone: 215-503-7874
PRIMARY OBJECTIVE:
I. To detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in our laboratory, which targets VPAC1 and/or STEAP1 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.
IV. To determine STEAP1 receptor density as a function of PCa GGl to 5 using receptors specific immunohistochemistry.
V. To determine STEAP1 expression as a function of PCa GG, 1-5 using quantitative RtPCR.
OUTLINE: This is an observational study.
Patients undergo collection of urine samples at baseline during standard of care office/clinic visit.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorMadhukar Thakur
