Detection of Prostate Cancer Using Voided Urine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation Into Detection of Prostate Cancer Using Voided Urine

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (biospecimen collection)<br>Patients undergo collection of urine samples at baseline during standard of care office/clinic visit. | Procedure: Biospecimen Collection<br>* Undergo collection of urine samples<br>* Other names: Specimen Collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the vasoactive intestinal polypeptide receptor (VPAC) assay diagnosis | The diagnostic properties of the assay will be assessed by estimating the sensitivity, specificity and positive and negative predictive values, along with their exact Clopper-Pearson 95% compatibility intervals. Subgroup estimates of specificity, positive and negative predictive values and exact compatibility intervals will be generated for comparisons between controls with and without benign prostatic hyperplasia (BPH). All study variables will be summarized and tabulated by prostate cancer status, BPH status, and by percent malignant cells (%M), fluorescence intensity, and VPAC protein quantity. Continuous variables will be summarized in groups by means with standard deviations or, of skewed, by medians with first and third quartiles and with other continuous variables by correlation coefficients. Discrete variables will be summarized by frequency counts and percentages. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations and expected values of aggressiveness | Spearman's correlation coefficients of aggressiveness (measured by Gleason score or prognostic grade group [PGG]) associated with increasing levels of %M, fluorescence intensity, and VPAC protein quantity will be estimated along with 95% compatibility intervals. Linear regression modeling will be used to evaluate how expected values of aggressiveness (measured by Gleason score or PGG are associated with increasing levels of %M, fluorescence intensity, and VPAC protein quantity, respectively, while adjusting for demographics or other study variables that appear to be confounders in preliminary summary analyses. Analyses will be conducted using SAS version 9.4. | Up to 2 years |