Detection of Prostate Cancer Using Voided Urine

NCT ID: NCT04788277

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 675 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2026-05-31

Brief 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.

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.

Conditions

Prostate Carcinoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Diagnostic (biospecimen collection)

Patients undergo collection of urine samples at baseline during standard of care office/clinic visit.

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of urine samples

Interventions

Biospecimen Collection

Undergo collection of urine samples

Intervention Type: PROCEDURE

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madhukar Thakur, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Madhukar Thakur, MD

Role: CONTACT

Madhukar.Thakur@jefferson.edu

215-503-7874

Facility Contacts

Madhukar Thakur, MD

Role: primary

Madhukar.Thakur@jefferson.edu

215-503-7874

Other Identifiers

JT 15161

Identifier Type: OTHER

Identifier Source: secondary_id

20G.196

Identifier Type: -

Identifier Source: org_study_id