Detection of Prostate Cancer Using Voided Urine

Description

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.

Conditions

Prostate Carcinoma

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Study Overview

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Study Details

Study overview

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.

Investigation Into Detection of Prostate Cancer Using Voided Urine

Detection of Prostate Cancer Using Voided Urine

Condition
Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)

Ages Eligible for Study

50 Years to 79 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Thomas Jefferson University,

Study Record Dates

2025-05