Detection of Prostate Cancer Using Voided Urine

Prostate Carcinoma Clinical Trial

Official title:

Investigation Into Detection of Prostate Cancer Using Voided Urine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04788277
• Other study ID #: 20G.196
• Status: Active, not recruiting
• Start date: February 26, 2020
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 675
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of urine samples

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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