Detection of Prostate Cancer Using Voided Urine
Status
RECRUITING
Phase
Age
50 - 79 Years
Enrollments
675Conditions
Prostate CarcinomaSummary
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.
Detailed 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.
Locations
1 location Found with status Recruiting
Eligibility Criteria
Inclusion Criteria:
* Provide signed and dated informed consent form
* Male
* Patients must be 50-70 years of age
* Willing to comply with all study procedures
* Prior to digital rectal exam (DRE)
* Patients with the diagnosis of prostate cancer (Cohort 1 N=150)
* Prior to radical prostatectomy/radiotherapy (XRT) or systemic therapy
* May be on active surveillance
* Patients with elevated PSA level but no know prostate cancer (Cohort 2 N=150)
* Diagnosis of BPH/lower urinary tract symptoms (LUTS)
* No prior diagnosis of prostate cancer
* Prior negative biopsy with PSA > 1.5
* Without biopsy PSA < 1.5
* Patients with normal PSA levels (Cohort 3 N=200)
* No documented history of BPH (no medical management or prior surgical treatment for BPH)
* PSA < 1.5
* No documented history of prostate cancer
* No documented history of urothelial carcinoma
* Patients Pre DRE and Post DRE (Cohort 4 N=200)**
* Patients on with a known Gleason Score (Cohort 5= 150)
Exclusion Criteria:
• Patients under the age of 50
Study Plan
Diagnostic (biospecimen collection)
Patients undergo collection of urine samples at baseline during standard of care office/clinic visit.
PROCEDURE:
Biospecimen CollectionDescription:
Undergo collection of urine samples
Outcome Measures
Primary Outcome Measures
Sensitivity and specificity of the vasoactive intestinal polypeptide receptor (VPAC) assay diagnosis
Secondary Outcome Measures
Correlations and expected values of aggressiveness
Timeline
Last Updated
June 27, 2024Start Date
March 9, 2021Today
January 16, 2025Completion Date ( Estimated )
May 1, 2025
Sponsors of this trial
Lead Sponsor
Thomas Jefferson University
RECRUITING 
21 - 64 Years