Prostate Cancer Clinical Trial
Detection of Prostate Cancer Using Voided Urine
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.
Full 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Philadelphia Pennsylvania, 19107, United States
How clear is this clinincal trial information?